Are you looking for a new role in Regulatory Affairs? CK Regulatory are currently recruiting for a number of great positions in Regulatory Affairs, here are just a few of them…
Regional Regulatory CMC Country Lead
This is a 6 month contract role based in Maidenhead.
Job purpose:
You will be responsible for managing a team of professionals that provide submission strategy for all registration activities within the countries under responsibility and driving forward all activities which will ensure timely submissions and approvals.
Main responsibilities:
- Lead the provision of submission strategy for execution of lifecycle submissions associated to the management of CMC changes originating at manufacturing sites.
- Lead regional/local management of lifecycle submissions in markets under responsibility including marketing authorisation amendments, variations, renewals.
- Coordinate with the publishing teams for the generation of the submission ready components required to support lifecycle submissions.
- Ensure that the CMC change management electronic systems are updated and maintained in alignment with the regulatory information submitted/approved.
- Act as a direct liaison with regulatory authorities to facilitate the prompt review and approval of submissions.
- Manage timely responses from questions raised by regulatory authorities.
- Compliance with department and company SOPs.
Person specification:
- Life sciences degree.
- Substantial work experience within regulatory affairs in the pharmaceutical industry.
- Experience in submission of CMC documentation.
- Experience liaising with regulatory authorities.
- Line management experience.
- Strong interpersonal skills.
For more information, or to apply, please contact Meera Pattni at CK Regulatory on 01438 743 047 or email mpattni@ckregulatory.com.
Quality Overall Summary and Module 3 Pharmaceutical Expert
Job purpose:
You will be responsible for producing Quality Overall Summary reports for new licence applications as well as ensuring that module 3 elements submitted are of good quality.
Scope of the role:
This role is based within the category R&D structure the role is positioned to support roll out of existing products to new countries. You will liaise closely with the QOS Manager and all module 3authors within the category R&D teams. You will be responsible for improving the quality of module 3s created and maintained by the R&D teams.
Main responsibilities:
- Produce Quality Overall Summary reports for revised module 3s createdby the R&D teams.
- Produce expert reports and statements if required to support licence variations.
- Review dossiers and variations prior to preparing QOSs.
- Ensure module 3s are of high quality.
- Day to day implementation of work associated with specific projects.
- High level of technical input at both theoretical and practical levels.
Person specification:
- Good graduate degree in life sciences.
- Experience preparing and approving elements of module 3.
- In depth knowledge of ICH and other external guidelines.
- Strong analytical and problem solving skills.
- Excellent communication skills.
- Ability to work under pressure and meet deadlines.
For more information, or to apply, please contact Meera Pattni at CK Regulatory on 01438 743 047 or email mpattni@ckregulatory.com.
Global Regulatory Manager – Health and Personal Care
My client are a leading global healthcare company with operations in over 60 countries and sales in over 180. Due to expansion within the department a new position has arisen within the Healthcare / Personal care products.
Reports to: Director, Global Regulatory – Health and Personal Care.
Job summary:
You will be responsible for determining regulatory strategy for Health and Personal Care products. You will work jointly with local regulatory teams to implement the strategies to secure and maintain marketing authorisations for H&PC products across Europe and International markets.
Scope of the role:
You will be required to define regulatory strategies for new product development and for existing products to be marketed in new regions. You will be required to work closely with relevant departments including Clinical, Medical and Product Safety to deliver the regulatory dossier required to support the launches in line with category strategy.
Main responsibilities:
- Develop and implement regulatory strategies that enable the delivery of a pipeline of product innovation to meet category strategies for relevant H&PC segments.
- Monitor, collect and interpret regulatory issues that will impact the companies product, policies and procedures.
- Interface and represent company interests with relevant government agencies/industry associations for the purpose of negotiating legislations, regulations and guidelines.
- Work closely with company personnel and contractors to define global registration dossiers.
- Provide regulatory expertise in the area of advertising, label claims and other written materials for new and existing products.
- Ensure safety evaluations and health risk assessments are carried out for products in accordance with company policy and guidelines.
- Help prepare responses to address any significant regulatory or safety issues relating to the products.
- Motivate and develop people within a results orientated culture.
Person specification:
- Educated to honours degree within life sciences.
- Substantial experience within Healthcare or Personal Care Products development and Regulatory Affairs.
- Ability to understand and interpret directives and regulatory guidelines.
- Experience with recruitment, management and development of people.
- Strong understanding of marketing strategy, planning issues, budgeting, andproject management.
- Excellent communication skills, fluency in English is essential.
- Openness to change.
For more information, or to apply, please contact Meera Pattni at CK Regulatory on 01438 743 047 or email mpattni@ckregulatory.com.
Senior Manager, Global Regulatory Affairs – Health and Personal Care
My client are a leading global healthcare company with operations in over 60 countries and sales in over 180. Due to expansion within the department a new position has arisen within the Healthcare / Personal care products.
Direct reports: 3 – 5, Indirect reports: 12 – 20
Job summary:
You will be required to lead category teams and drive growth through regulatory affairs. You willbe responsible for developing regulatory strategy for Health and Personal Care products and working with regulatory teams to implement these strategies to secure and maintain marketing authorisations for these products across the European and International regions.
Scope of the role:
You will provide leadership in developing regulatory strategy to drive growth for the assigned brands and take overall accountability for more than one category brand. As part of the role you will recruit and develop human resource and regulatory expertise for a large team to sustain growth. You will also be responsible for delivering regulatory dossiers which are compliant with regional regulatory requirements for the newer regions and will be required to take provide regulatory advice and strategic input to colleagues in other countries.
Main responsibilities:
- Develop and implement regulatory strategies that enable the delivery of a pipeline of product innovation to meet Category Strategies for all key geographies.
- Responsible for the creation and assembly of regulatory dossiers for assigned categories.
- Lead the preparation of responses to questions from the regulatory authorities across the world to address regulatory issues relating to MAAs and product licence maintenance.
- Provide leadership to team members in developing regulatory strategies.
- Monitor, collect and interpret regulatory issues that will impact the company products, policies and procedures.
- Advise Global Category Development, Supply and Scientific Services Group on regulatory requirements and regulatory impact during New Product Development and maintenance process for projects intended for launch.
Person specification:
- Life sciences degree.
- Substantial line management experience, including recruitment.
- Extensive experience within Health and Personal Care Product Regulatory Affairs, experienced at both category and country levels desirable.
- Track record of delivering marketing authorisations in key geographies.
- Excellent leadership, communication and analytical skills.
- Ability to motivate teams and build strong working relationships.
- Understanding of P&L management.
- Strong intellectual curiosity.
For more information, or to apply, please contact Meera Pattni at CK Regulatory on 01438 743 047 or email mpattni@ckregulatory.com.
