Posts Tagged ‘Regulatory Affairs Jobs’
Monday, November 14th, 2011
Meera Pattni at CK Regulatory is recruiting for an Associate Director of Regulatory Affairs to join a successful pharmaceutical company based in London.
The role:
As Associate Director of Regulatory Affairs you will be required to plan, manage and execute regulatory activities related to global regulatory leadership for one or more projects. In addition, you will also provide regulatory therapeutic area strategic guidance on development projects and marketed products. Further responsibilities will include:
- Manage and hire therapeutic area product development regulatory affairs staff.
- Act as regulatory contact person for global project team on selected products.
- Act as regional therapeutic area regulatory representative for specific project and products.
- Prepare monthly reports detailing any development activities.
- Responsible for due diligence and feasibility assessments of candidates in a therapeutic area.
The ideal candidate:
Meera is looking for candidates with the following skills, experience and qualifications:
- Life sciences degree.
- Previous line management experience.
- Pharmaceutical industry knowledge essential.
- Experience within regulatory affairs.
How to apply:
For more information or to apply for this Associate Director of Regulatory Affairs position, please contact Meera Pattni at CK Regulatory on +44 (0) 1438 870024 or email mpattni@ckregulatory.com.
Not quite what you’re looking for? Click here to search our current Regulatory Affairs jobs now.
Tags: associate director of regulatory affairs job in london, associate director regulatory affairs, London, Regulatory Affairs, Regulatory Affairs Jobs, regulatory affairs jobs in London, Regulatory Affairs recruitment
Posted in Featured Job, News | No Comments »
Thursday, November 3rd, 2011
Meera Pattni at CK Regulatory is currently recruiting for a Regulatory Documentation Publisher to join a pharmaceutical company based in Basel.
The role:
As the Research Regulatory Documentation Publisher you will be required to support the submission process of scientific documents to the appropriate regulatory team. The publisher will be responsible for preparing scientific reports for regulatory submission use while supporting the department submission coordinator.
Responsibilities:
- Coordinating the different positions throughout the process of releasing internal scientific documents to Health Authority submissions requesting Clinical Trials.
- Formatting scientific reports in MS Word by applying corporate formatting standards.
- Ensuring timely input from authors & other positions and incorporating their input into appropriate documents.
- Managing quality control on selected reports at different stages of the process.
The ideal candidate:
Meera is looking for candidates with the following skills, experience and qualifications:
- Excellent communication skills in both written and oral English.
- Ability to manage multiple projects at once.
- Ability to work to deadlines.
- Proficiency in MS Word.
- Strong attention to detail.
- Willingness to think independently and take a flexible approach to documentation.
How to apply:
For more information or to apply for this Regulatory Documentation Publisher position, please contact Meera Pattni at CK Regulatory on 01438 743047 or email mpattni@ckregulatory.com. Please quote reference CL23069 in all correspondence.
Tags: Jobs for regulatory affairs, jobs in regulatory affairs, jobs regulatory affairs, meera pattni, pharma regulatory affairs jobs, Pharmaceutical regulatory affairs jobs, Pharmaceutical regulatory affairs jobs uk, Reg Affairs Jobs, reg affairs jobs uk, Regulatory Affairs Jobs, Regulatory affairs jobs in uk, regulatory affairs jobs uk, Regulatory Affairs recruitment, regulatory affairs recruitment uk, regulatory documentation publisher job basel, regulatory documentation publisher jobs, Switzerland
Posted in Featured Job, News | No Comments »
Tuesday, November 1st, 2011
Meera Pattni at CK Regulatory is currently recruiting for a Regulatory Affairs Officer to join a pharmaceutical company which specialises in the development and marketing of oral liquid medicines.
The role:
As Regulatory Affairs Officer you will help to collate documents in preparation for variations and Marketing Authorisation Applications.
Main responsibilities:
- Advise departments of regulatory information regarding approved shelf life, suppliers etc.
- Help collate documents for Marketing Authorisation Applications.
- Prepare type I and II variations.
- Apply for Export Certificates including legislation and notarisation as necessary.
- Regulatory administrative tasks.
- Initiation of packaging around the internalsystem and initial checks.
The ideal candidate:
Meera is looking for candidates with the following qualifications, skills and experience:
- Life sciences degree.
- Previous experience within regulatory affairs highly desirable.
- Ability to work to deadlines.
- Good written language skills.
- Ability to solve problems.
How to apply:
For more information or to appy for this Regulatory Affairs Officer position, please contact Meera Pattni on 01438 870024 or email mpattni@ckregulatory.com. Please quote reference CL23048 in all correspondence.
Tags: ck regulatory, ck regulatory jobs, ck regulatory recruitment, meera pattni, Pharmaceutical, pharmaceutical industry, pharmaceutical regulatory affairs, Regulatory Affairs Jobs, regulatory affairs officer job in west yorkshire, regulatory affairs officer job west Yorkshire, regulatory affairs officer jobs, regulatory affairs officer jobs uk, Regulatory Affairs recruitment, uk
Posted in Featured Job, News | No Comments »
Monday, October 17th, 2011
Meera Pattni at CK Regulatory is recruiting for a Regulatory Affairs Engineer to be based in West Sussex.
The role:
As Regulatory Affairs Engineer, you will support the Quality and Regulatory Affairs Manager in achieving regulatory goals and objectives by proactively supporting the organisation in achieving the necessary regulatory submissions for the targeted markets. In addition, you will also be required to develop and maintain worldwide regulatory knowledge in the preparation of regulatory submissions and registrations.
Main responsibilities:
- Identify and provide advice and guidance on worldwide regulations throughout the organisation to ensure that up to date knowledge is maintained and implemented.
- Control the preparation and maintenance of submissions to regulatory authorities for all targeted markets.
- Collaborate with Compliance Engineers to provide Regulatory advice and guidance.
- Support Business Units and Distributors world wide during the tendering process byproviding supporting documentation and certification including Manufacturers Declarations.
- Provide regulatory determinations when required by CFR committees.
- Perform regulatory review on business documentation.
- Liaise with regulatory authorities.
- Advise on installation issues relating to new product development and the installed base.
The ideal candidate:
Meera is looking for candidates with the following skills and experience:
- Ability to interpret, adapt and provide guidance on product registration.
- Proven track record in regulatory affairs.
- Good communication skills.
- Previous experience within medical devices.
How to apply:
For more information or to apply for this Regulatory Affairs Engineer position, please contact Meera on 01438 870024 or email mpattni@ckregulatory.com. Please quote reference CL22950 in all correspondence.
Tags: Jobs for regulatory affairs, jobs in regulatory affairs, jobs regulatory affairs, meera pattni, pharma regulatory affairs jobs, Pharmaceutical regulatory affairs jobs, Pharmaceutical regulatory affairs jobs uk, Reg Affairs Jobs, reg affairs jobs uk, regulatory affairs engineer jobs, regulatory affairs engineer jobs west sussex, Regulatory Affairs Jobs, Regulatory affairs jobs in uk, regulatory affairs jobs uk, Regulatory Affairs recruitment, regulatory affairs recruitment uk
Posted in Featured Job, News | No Comments »
Tuesday, October 11th, 2011
Meera Pattni at CK Regulatory is currently recruiting for an Associate Director of Regulatory Affairs to be based in the North West of England.
Responsibilities:
- Direct and prepare regulatory submissions as required for global approvals for IVDs, including preparation of reports and interaction with regulatory officials.
- Review product labelling and promotional literature for regulatory compliance.
- Research and interpret regulations, guidelines and precedents to support interdepartmental project teams in developing strategies, policies and procedures that ensure regulatory compliance with global regulatory agencies.
- Liaise with regulatory agencies for enquiries and issues.
- Review R&D protocols and technical reports and other company documents for use in regulatory submissions and in response to questions from regulatory authorities.
- Oversee and direct the preparation of regulatory documentation for country specific registrations.
- Develop regulatory SOPs relevant for registration of IVD products or other regulatory aspects.
Person specification:
- Extensive experience in the medical device industry, preferably with IVD experience and extensive regulatory affairs experience.
- Experience in the preparation and submission of 510K, PMAs, IND, CE Design Dossiers, CE Technical Files.
- Possess a working knowledge of MDD and IVDD, applicable ISO standards.
- Ability to work as part of a team.
- Excellent influencing and negotiating skills.
- Excellent verbal and written communication skills.
How to apply:
For more information or to apply for this Associate Director of Regulatory Affairs position, please contact Meera on 01438 870024 or email a copy of your CV to mpattni@ckregulatory.com. Please quote reference CL22924 in all correspondence.
Tags: Associate Director of Regulatory Affairs Job in North West, Director of Regulatory Affairs, director of regulatory affairs north west, Jobs for regulatory affairs, jobs in regulatory affairs, jobs regulatory affairs, meera pattni, pharma regulatory affairs jobs, Pharmaceutical regulatory affairs jobs, Pharmaceutical regulatory affairs jobs uk, Reg Affairs Jobs, reg affairs jobs uk, Regulatory Affairs Jobs, Regulatory affairs jobs in uk, regulatory affairs jobs uk, Regulatory Affairs recruitment, regulatory affairs recruitment uk, uk
Posted in Featured Job, News | No Comments »
Monday, October 3rd, 2011
Meera Pattni at CK Clinical is recruiting for a Global Regulatory Affairs CMC Associate to join a successful and innovative pharmaceutical company at their site in Yorkshire, UK.
The job:
As Global Regulatory Affairs CMC Associate, you will be required to assist the new product development and existing product development projects within the scope of the global regulatory CMC team. You will also assist and support regulatory CMC strategy and deliver submissions.
Responsibilities:
- Deliver global regulatory affairs CMC project activities by effective coordinator, strategy and implementation.
- Prepare and deliver regulatory submissions including CTAs, MAAs, INDs and variations/renewals in line with defined CMC plans.
- Work collaboratively with appropriate company personnel and contractors to coordinate the regulatory work stream elements for CMC activities.
- Liaise with regulatory authorities as required.
- Maintain documented regulatory project plans in line with best practice recommendations.
- Facilitate and support the development and documentation of revised regulatory processes in line with global processes within the CMC team.
The ideal candidate:
Meera is looking for candidates will the following skills:
- Excellent communication skills.
- Highly organised.
- Ability to handle multiple projects at once.
- Results orientated.
- Strong negotiating and interpersonal skills.
- Openness to change.
How to apply:
For more information or to apply, please contact Meera on 01438 870024 or email mpattni@ckregulatory.com. Please quote reference CL22877 in all correspondence.
Tags: Global Regulatory Affairs CMC Associate Job in Yorkshire, Jobs for regulatory affairs, jobs in regulatory affairs, jobs regulatory affairs, meera pattni, new product development, pharma regulatory affairs jobs, Pharmaceutical regulatory affairs jobs, Pharmaceutical regulatory affairs jobs uk, Reg Affairs Jobs, reg affairs jobs uk, Regulatory Affairs, Regulatory Affairs Jobs, Regulatory affairs jobs in uk, regulatory affairs jobs uk, Regulatory Affairs recruitment, regulatory affairs recruitment uk, regulatory CMC, regulatory strategy, Regulatory Submissions, uk
Posted in Featured Job, News | No Comments »
Friday, September 2nd, 2011
Pharmaceutical-business-review.com has reported that French pharmaceutical company Roche has received approval from the European Commission (EC) for lung cancer drug Tarceva.
The drug can now be used as a treatment on it’s own to treat patients with locally advanced or metastatic lung cancer. Prior studies have shown that Tarceva nearly doubles the amount of time patients survive without their cancer progressing when compared to chemotherapy.
Hal Barron, Roche’s head of Global Product Development and chief medical officer believes the European approval to be good news for those with genetically distinct forms of the cancer because they can receive a greater benefit when the medicine is used as an initial treatment.
Looking for a job in regulatory affairs? Start by clicking here, now
Tags: CK Clinical, ck regulatory, ck science, Clinical jobs, clinical recruitment, EU, European Commission, European Regulatory Affairs, jobs in reg affairs, jobs in regulatory affairs, Reg Affairs Jobs, Reg Affairs Recruitment, Regulatory Affairs Jobs, Regulatory Affairs recruitment, Roche, uk
Posted in General, News | No Comments »
Tuesday, August 30th, 2011
Meera Pattni at CK Regulatory is recruiting for a Senior Regulatory Engineer to be based in the Netherlands.
The Company
Meera’s client is a global marketer of consumer and commercial products that develop innovative products and system solutions in the categories of food service, cleaning, safety, material handling, refuse and agriculture amongst others.
The Job
As Senior Regulatory Engineer, you will be responsible for coordinating and auctioning activities within regulatory affairs to ensure that all manufactured products and services provided by the company meet the quality requirements of the company, regulatory and notified bodies.
Responsibilities:
- Manage the regulatory affairs area to ensure that objectives are implemented in line with overall quality/corporate goals.
- Ensure compliance with local regulatory agencies and establish relationships with outside testing facilities as required.
- Provide update regarding regulatory status and requirements of company products. Ensure customers receive regulatory and certification information in a timely manner.
- Compile device master records, technical files, design dossiers, FDA and European submission documents that meet regulatory requirements.
- Ensure staff understand and comply with the requirements of cGMP as applied to the company products.
- Review Change Control requests, deviation requests, quality system reports for adequacy and compliance with company and regulatory requirements.
- Participate in the development and maintenance of the Company’s Quality System to meet the requirements of the US FDA and other applicable quality and regulatory standards.
You:
The ideal candidate for this Senior Regulatory Engineer will have the following skills and experience:
- Degree in a science or quality related subject.
- Previous experience in a quality or regulatory affairs role essential.
- Experience in the development and management of regulatory submissions and documents.
- Experience with internal and external audit processes.
- Demonstrated expertise in cGMPs, FDA regulations, SOP development.
Apply now:
For more information or to apply online for this Senior Regulatory Engineer position, please contact Meera Pattni at CK Regulatory on 01438 743 047 or email mpattni@ckregulatory.com. Please quote reference CL22593 in all correspondence.
Tags: EME, FDA, Jobs for regulatory affairs, jobs in regulatory affairs, jobs regulatory affairs, pharma regulatory affairs jobs, Pharmaceutical regulatory affairs jobs, Pharmaceutical regulatory affairs jobs uk, Reg Affairs Jobs, reg affairs jobs uk, Regulatory Affairs, Regulatory Affairs Jobs, Regulatory affairs jobs in uk, regulatory affairs jobs uk, Regulatory Affairs recruitment, regulatory affairs recruitment uk, regulatory compliance, regulatory jobs in the Netherlands, regulatory jobs Netherlands, Regulatory Submissions, Senior Regulatory Affairs, Senior Regulatory Engineer Job in the Netherlands
Posted in Featured Job, News | No Comments »
Friday, August 26th, 2011
Meera Pattni at CK Regulatory is currently helping a number of excellent Regulatory Affairs candidates looking for both permenant and contract positions. Please see below to find out more:
Junior Regulatory Professional
Meera is currently helping this Junior Regulatory Professional to find a new position.
This excellent candidate has recently completed a Masters in Clinical Research and has experience in:
- Preparing registration documents for marketing approval
- Drafting MHRA submissions for device approvals
Open to both permanent and contract positions, this candidate is available at short notice.
Regulatory Consultant
Meera Pattni at CK Regulatory is currently helping a Regulatory Consultant to find a new contract role close to the M4 corridor.
This candidate has experience in the following:
- Life cycle management on marketed products within neurology, oncology and haematology.
- Coordinating preparation for Scientific Advice Meetings with Regulatory Agencies in Europe.
- Developing regulatory strategies for development and marketed products.
- Contributing on regulatory aspects of Risk Management Plan.
Senior Regulatory Operations Professional
Meera at CK Regulatory is currently helping a Senior Regulatory Operations Professional to find a new permanent or contract role.
Available immediately, this candidate has experience in:
- Providing strategic submission intelligence to colleagues.
- Ensuring submissions meet EU, FDA and ICH guidelines.
Medical Devices Regulatory Specialist
Meera Pattni at CK Regulatory is helping a Medical Devices Regulatory Specialist to find a new role in the South East.
This candidate has excellent experience in:
- Generating technical dossiers to meet global regulatory requirements for markets including FDA, Japan, Brazil and Europe.
- Internal auditing.
- Working with Class I, IIa and IIb medical devices.
- Generating local department quality systems procedures.
For more information regarding any of the candidates detailed above, please contact Meera Patti at CK Regulatory on 01438 743 047 or email mpattni@ckregulatory.com.
Tags: ck regulatory, junior regulatory professional, medical devices regulatory specialist, meera pattni, regulatory affairs candidates, Regulatory Affairs Jobs, Regulatory Affairs recruitment, regulatory associate, Regulatory Consultant
Posted in Candidate of the Week, News | No Comments »
Tuesday, August 23rd, 2011
Meera Pattni is currently helping a global pharma company to recruit for a Junior Global Regulatory Program Manager to join their team based in Basel.
Job purpose:
You will work under some supervision to provide support to the Senior Global Regulatory Program Manager for programs through development, registration, approval/post approval. Based the global regulatory strategy, you will implement global regulatory plans for their assigned regions and assist with compliance activities.
Main responsibilities:
Regulatory Strategy:
- Support arrangements of the Company’s regulatory advisory board on regulatory strategy.
- Contribute to the plans for global regulatory readiness with other line functions.
- Serve as the drug regulatory affairs representative on product sub teams.
Health Authority interactions:
- Implement plans for HA interactions as determined by the Senior GRPM.
- Coordinate responses to HA requests.
- Coordinate rehearsals to HA meetings.
Submissions and Approvals:
- Assist with the preparation, QC and submission of worldwide dossiers and maintenance submissions.
- Ensure timely availability of supporting documents.
- Collaborate on the development and implementation of plans to avoid/minimise clock stops during submission.
- Coordinate regulatory activities and submit CTA and INDs with supervision.
Prescribing information:
- Coordinate the regulatory strategic input provided on the prescribing information.
- Revise labels as needed to achieve timely health authority approval.
Regional Excellence and Compliance:
- Prepare annual reports and renewals and ensure on time submissions to health authorities.
- Enter product specific attributes as provided by the Senior GRPM in to compliance database.
- Provide support as needed for non project related regional excellence activities.
Promotional/Non-Promotional Review:
- Assist in the review of promotional and non-promotional materials and press releases as required and work with the GRPD to ensure messages are consistent with the Company’s policies and guidelines.
The ideal candidate:
To be considered for this position, you will have the following skills, experience and qualifications:
- Previous experience within pharmaceutical regulatory affairs.
- Life sciences degree essential.
- Awareness of the drug development process.
- Good communication and negotiation skills.
- Ability to work in cross functional teams.
- Ability to work as part of a team.
How to apply:
For more information or to apply for this Junior Global Regulatory Program Manager please contact Meera Pattni on 01438 743 047 or email mpattni@ckregulatory.com. Please quote reference CL22640 in all correspondence.
Tags: Jobs for regulatory affairs, jobs in regulatory affairs, jobs regulatory affairs, Junior Global Regulatory Program Manager Job – Basel, pharma regulatory affairs jobs, Pharmaceutical regulatory affairs jobs, Pharmaceutical regulatory affairs jobs uk, Reg Affairs Jobs, reg affairs jobs uk, Regulatory Affairs Jobs, Regulatory affairs jobs in uk, regulatory affairs jobs uk, Regulatory Affairs recruitment, regulatory affairs recruitment uk
Posted in Featured Job, News | No Comments »
