Regulatory Affairs Associate Director
|Job Title:||Regulatory Affairs Associate Director|
|Contact Name:||Richard Williamson|
|Job Published:||January 06, 2017 08:35|
I am exclusively recruiting for a Boutique Consultancy in the Cambridgeshire area who are searching for an Associate Director of Regulatory Affairs to join their ever expanding team who specialise in supporting clients in the development of ground-breaking treatments for human disease and inherited disorders.
The role is permanent & based in the office.
The appointed candidate to this dynamic consultancy will report to the Director, Regulatory Affairs and will be accountable for the preparation and management of a wide range of regulatory submissions for clients in the EU and US. They will work both independently on their own projects, and support the wider regulatory team as necessary.
This individual will have a solid understanding of EU human medicinal product legislation and hands-on experience with the procedural aspects and writing of regulatory submissions including IMPDs, CTAs, Orphan Drug applications, Scientific Advice procedures, Paediatric Investigation Plans and MAA and marketing applications in Common Technical Document format.
It is essential that the candidate has excellent written and effective verbal communication skills, is able to independently project manage submissions, is flexible, and able to work to deadlines. Experience of biologicals, and in particular Advanced Therapy Medicinal Products is highly desirable, in particular experience of preparing CMC documentation for these products.
It is essential that the candidate has excellent written and effective verbal communication skills, is able to independently project manage submissions, is flexible, and able to work to deadlines.
Experience of biologicals, and in particular Advanced Therapy Medicinal Products is highly desirable, in particular experience of preparing CMC documentation for these products.
Reporting to the Director of Regulatory Affairs, the incumbent will:
- Actively contribute to the development and implementation of regulatory strategy for assigned projects.
- Interact directly and effectively with existing regulatory team, external consultants, clients and regulatory agencies in the EU/US
- Prepare and perform thorough review of submissions taking into account relevant guidance pertaining to document content.
- Coordinate and maintain regulatory submissions (e.g., IMPD/CTAs and amendments, Orphan Drug applications, annual reports, meeting packages, etc.) in accordance with applicable regulations.
- Coordinate internal/external authoring/review/comment adjudication and finalization (submission and archival).
- Develop and maintain current regulatory knowledge.
QUALIFICATIONS AND BACKGROUND REQUIREMENTS
- Bachelor's degree in a biological or pharmaceutical discipline. Higher degree an advantage.
Professional Work Experience
- Candidate must have at least 7 years of direct regulatory experience in the pharmaceutical or biotechnology industry, with demonstrated increasing expertise and responsibility.
- Experience of authoring regulatory documents from source documentation is essential
- Experience of client-facing consultancy is highly desirable
- Experience of working with biological and innovative products is highly desirable.
- A wide breadth of understanding of the drug development process including clinical, non-clinical and CMC aspects is desirable.
This is a permanent position in a small consultancy with high levels of scope for professional development in the management of novel new medicines, including (but not limited to) the gene and cell therapy area. Re-numeration package based on individual experience and skills.
This position will be based at our office in Cambridge.
Domestic and international travel required.
For more information on this role - please contact Rich Williamson on 02033273072 or apply to this advert.
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