Featured Job

Head of R&D Regulatory Affairs Job in West Sussex

Wednesday, November 30th, 2011

Meera Pattni at CK Regulatory is currently recruiting for a Head of R&D Regulatory Affairs to join a successful pharmaceutical company based in West Sussex.

The role:

As Head of R&D Regulatory Affairs you will be responsible for ensuring  proper procedures and processes are in place to meet compliance needs. You will also ensure Pharmacovigilance activities are in line with SOPs.

Further responsibilities of this Regulatory Affairs position will include:

  • Develop UK Regulatory/Medical Affairs plans and take corrective actions when needed to ensur etimelines and objectives are achieved.
  • Develop/build on strong and sustainable relationships with Health Authorities to overcome barriers and expedite product registration processes.
  • Ensure customer excellence by delivering quality support for the Company’s project review boards and regional Innovation and BD&L process and collaborate to deliver planned sales aligned with annual business plans.
  • Monitor country government actions, legislation and OTC industrial organisation actions.
  • Ensure operational excellence through effective implementation of global regulatory information management and global labelling compliance initiative.
  • Ensure compliance review of the portfolio in collaboration with Region/Global QA.
  • Build drug regulatory affairs/medical affairs organisation in line with strategic plan.
  • Knowledge of global pharmacopeias, local and global regulations, compendiums, innovative new techniques.
  • MA submissions, approvals in line with Global / Region objectives.
  • RA Compliance review in line with annual plans.

The ideal candidate:

Meera is looking for candidates with the following qualifications, experience and skills:

  • Life sciences degree, educated to Masters level preferable.
  • Strong background in regulatory affairs.
  • Line management experience essential.
  • Pharmacist background preferable.
  • Understanding of local market business needs and environment.
  • Strong communication and negotiation skills.
  • Strong interpersonal skills.

How to apply:

For more information or to apply for this Head of R&D Regulatory Affairs position, please contact Meera Pattni at CK Regulatory on 01438 870024 or email mpattni@ckregulatory.com. Please quote reference CL23209 in all correspondence.

Not quite what you’re looking for? Click here to search our current Regulatory Affairs jobs in the UK now.

Head of Regulatory Affairs Job in Wiltshire, UK

Tuesday, November 29th, 2011

Meera Pattni at CK Regulatory is currently recruiting for a Head of Regulatory Affairs to join a pharmaceutical company based in Wiltshire.

 

The role:

As Head of Regulatory Affairs, you will be responsible for the managerial leadership of the Regulatory Affairs and Pharmacovigilance departments to deliver the goals for the company projects and products. You will also provide leadership on development activities requiring Regulatory and Pharmacovigilance input in both US and EU.

Further responsibilities will include:

  • Provide leadership of the Regulatory and Pharmacovigilance activities to ensure the timely development of products.
  • Develop, gain approval for, and implement regulatory strategy for the company’s project and products and provide regulatory intelligence and advice throughout the company.
  • Recruit, train, develop and lead staff in order to maximise their contribution to the success of the company.
  • Propose and agree an annual budget for Regulatory Affairs Department, and manage the department within the budget.
  • Evaluate product development opportunities and support commercial discussions and negotiations.
  • Liaise with Regulatory Authorities and third parties as necessary.
  • Ensure compliance to internal and external procedures and guidelines to meet requirements of GCP.
  • Represent the Company in interactions with external organisations.

 

The ideal candidate:

To be considered for this Head of Regulatory Affairs you will have the following skills, experience and qualifications:

  • Life sciences degree.
  • Strategic management experience.
  • Experience of prioritising own and others workload.
  • Apply effective management skills to achieve results.
  • Ability to make decisions under pressure.
  • Ensure quality systems are implemented.

 

How to apply:

For more information or to apply for this Head of Regulatory Affairs position, please contact Meera Pattni on 01438 870024 or email mpattni@ckregulatory.com. Please quote reference CL23204 in all correspondence.

Not quite what you’re looking for? Click here to search our current Regulatory Affairs jobs now.

Junior Medical Writer Job in Cambridge

Wednesday, November 23rd, 2011

A Junior Medical Writer is required to join a Regulatory Affairs Consultancy based in Cambridge. This is an excellent opportunity to work with a very busy and fast growing company with excellent prospects to progress. 

Key responsibilities:

  • Prepare tabulated summaries along with preparation of in-text tables or narratives for the Senior Medical Writers or Medical Writer.
  • Create of hyperlinks and bookmarks as required. 
  • Carry out numeric Quality Control of documents as required under the supervision of the Medical Writer. 
  • Plan schedule and track all assigned medical writing activities to ensure high quality, timely and accurate completion.
  • Provide regular status updates to the Medical Writer for all assigned medical writing activities.
  • Under supervision write low complexity CSR /NCSR. 
  • Compile current study reports within the EDMS environment
  • Requesting required documents from the client, or other departments as appropriate
  • Checking documents for compliance with EDMS requirements
  • Entering documents into the EDMS structure
  • Interact and effectively communicate with other groups in order to source clinical documents as required.
  • Assessing documents for completeness and quality
  • Produce documents using other software packages as required.
  • Perform any other activity as may reasonably be required from time to time. 
  • Complete all of the above activities within the framework and in compliance with ICH Guidelines, R&D SOPs and other documentation in force within the company

 

Location: Cambourne, Cambridge

Reference: MED_WR_02

Please reply with your CV and cover letter to jobs@elc-group.com

Senior Regulatory Affairs Professional Job based in Cambridge, UK

Wednesday, November 23rd, 2011

An outstanding opportunity for a Senior Regulatory Affairs Professional to join a well established Regulatory Consultancy Company and play an instrumental role in the growth of the business.

Duties will include:

  • management of product licence registration and post registration activities with the appropriate regulatory authorities on a global basis
  • preparation of any regulatory dossiers and/or supporting documentation
  • supporting clients with the appropriate documentation to facilitate registration/maintenance of products
  • providing leadership and guidance to junior stuff and ensuring site activities comply with regulatory requirements.
  • reviewing and interpreting regulatory guidelines.
  • Providing in house training on regulatory topics as required
  • Supporting marketing and business development activities. This may include (but not be limited to):

-   advising on regulatory activities, timelines and costs for new business proposals as required

-   participating in new business meetings, kick off meetings and project meetings as required.

The candidate should be qualified in Life Sciences and have broad experience in pharma regulatory environments for US/EU markets. Sound knowledge of Global Regulatory Procedures, including marketing applications, negotiation and product licensing knowledge, proven success in agency influencing and negotiation are essential. Broad level of experience within the Pharmaceutical industry with knowledge of Regulatory Affairs and knowledge of product development is a must.

If you feel you have the relevant skills and experience for this role please send your application to jobs@elc-group.com. Please quote reference S_RAPM in all correspondence.

Regulatory Affairs Professional Job based in Cambridge, UK

Wednesday, November 23rd, 2011

An outstanding opportunity for a Regulatory Affairs professional to join a well established Regulatory Consultancy Company and play an instrumental role in the growth of the business. You will be responsible for identifying and developing new business to ensure the regulatory sales targets are met or exceeded.

The person

Suitable candidates will have a background in sales / marketing of a scientific consultancy service. You will have sound knowledge of Global Regulatory Procedures, including marketing applications, negotiation and product licensing knowledge, proven success in agency influencing and negotiation. Broad level of experience within the Pharmaceutical industry with knowledge of Regulatory Affairs and knowledge of product development is a must.

You must have excellent communication skills, be a good listener, be commercially minded and able to develop complex and diverse proposals / solutions for clients’ requirements.

You will have the ability to network with colleagues and co-workers appropriately and to manage the communication to and collaboration of decision-making members of each project team. 

Typical activities may include:

  • Providing regulatory strategy and technical consultancy for the Regulatory Affairs Business Development Team and Project Management Team as well as regulatory consultancy and strategic advice to the clients;
  • Reviewing and providing technical advice to prepare regulatory submissions;
  • Contributing to development and implementation of global and regional regulatory functions;
  • To assist in business development in securing new business and making presentations to clients;
  • Maintaining and developing relationships with existing customers via meetings, telephone calls and emails;
  • Visiting potential customers to prospect for new business;
  • Acting as a contact between a company and its existing and potential markets;
  • Negotiating the terms of an agreement and closing sales;
  • Gathering market and customer information;
  • Representing the organization at trade exhibitions, events and demonstrations;
  • Negotiating variations in price, delivery and specifications with managers
  • Advising on forthcoming product developments and discussing special promotions;
  • Liaising with Project Managers to check on the progress of existing orders;
  • Recording sales and order information and sending copies to the sales manager;
  • Reviewing own sales performance, aiming to meet or exceed targets;
  • Gaining a clear understanding of customers’ businesses and requirements.    

Offer:

• Competitive basic salary
• Attractive commissions package with no caps
• Bonuses 

 

How to apply:

Please reply with your CV and cover letter to jobs@elc-group.com

Location: Cambourne, Cambridge

Ref: RABD_1

Survey: Advice for entry level Regulatory Affairs candidates

Tuesday, November 22nd, 2011

Create your free online surveys with SurveyMonkey, the world’s leading questionnaire tool.

Associate Director of Regulatory Affairs Job in London

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.

Keep track of Regulatory Affairs events with the new smart phone app

Monday, November 14th, 2011

The Organisation for Professionals in Regulatory Affairs (TOPRA) has developed both an iPhone and Android app to help professionals working in reg affairs to keep up-to-date with their events.

With one click of a button, you can add any event to your calendar and visit the TOPRA website for more information.

TOPRA is the global organisation for Regulatory Affairs professionals and for those who have an interest in Regulatory Affairs in the healthcare sector. Their current membership is drawn from over 40 countries and members worldwide are actively involved in delivering the services needed by busy regulatory specialists. Members are drawn from industry, the regulatory agencies and the consultancy community and work in all sectors including medical technologies, biotech, borderline products and pharmaceuticals.

To download the app from  iTunes, please click here.

Regulatory Affairs Programme Manager Job in North Devon

Wednesday, November 9th, 2011

Meera Pattni at CK Regulatory is recruiting for a Regulatory Affairs Programme Manager to join a leading global healthcare supplier based in North Devon.

The role:

As Regulatory Affairs Programme Manager you will report into the Head of Regulatory Affairs and will provide regulatory support and advice to the business with a primary focus on the OTC medicines sector in the UK and EU. In addition, as part of the EU Regulatory Team you will also be responsible for the submission and maintenance of product licences and marketing authorisations to the relevant authorities.

 

Responsibilities:

  • Submission of MA applications, variations and other regulatory applications within agreed timescales
  • Obtain new MA in line with company business plans
  • Review of artwork to ensure compliance with regulation
  • Effective management of special regulatory projects
  • Resolve MHRA delays by providing timely and accurate responses to information requests.
  • Provide regulatory and technical advice to the product development as required to ensure products are developed in compliance with regulations

 

The ideal candidate:

Meera is looking for candidates with the following experience, skills and qualifications:

  • Life sciences degree is essential
  • Previous experience within regulatory affairs and OTC is essential.
  • Ability to organise workload and prioritise tasks
  • Excellent communication skill

 

How to apply:

For more information or to apply for this Regulatory Affairs Programme Manager position, please contact Meera Pattni at CK Regulatory on 01438 870024 or email your CV to mpattni@ckregulatory.com. Please quote reference CL23072 in all correspondence.

 

Not quite what you’re looking for? Click here to search our current Regulatory Affairs jobs now.

Senior ePublisher Job in Hertfordshire

Tuesday, November 8th, 2011

Meera Pattni at CK Regulatory is currently recruiting for a Senior ePublisher to join a highly successful Pharmaceutical company based in Hertfordshire, UK.

The role:

As Senior ePublisher, you will be responsible for supporting the maintenance of eCTD Lifecycles. You will be involved in formatting of word documents, pre and post publishing activities, along with QC as necessary.

Main responsibilities:

  • Responsible for supporting lifecycle publishing projects for MAAs including NT/DCP/CP and MRP submissions.
  • Responsible for supporting NeeS and paper submissions as required.
  • Liaising with Senior Global Operations management and RA staff as required.
  • Assisting with formatting of word documents, post publishing and QC when necessary.
  • Support internal process development.
  • Ensuring all quality standards are upheld PQC.
  • Supporting internal DMS management and workflows.
  • Strategising activities in support of management projects.
  • Maintenance of all internal archiving procedures.
  • Supporting presentations when necessary within group and submission project team meetings.
  • Interaction with EU affiliates as required.

 

The ideal candidate:

Meera is looking for candidates with the following skills, experience and qualifications:

  • Regulatory operations experience is essential.
  • Hands on experience with electronic publishing (NeeS/eCTD).
  • Experience of following systems and programs eDMS/Adobe Acrobat Professional.
  • Preferably a life sciences degree.
  • Excellent Adobe Acrobat skills.

 

How to apply:

For more information or to apply for this Senior ePublisher role, please contact Meera Pattni at CK Regulatory on +44(0)1438 870024 or email mpattni@ckregulatory.com. Please quote reference CL23087 in all correspondence.

Not quite what you’re looking for? Click here to search our current Regulatory Affairs jobs now.