Senior Manager / Associate Director - Regulatory Affairs - Hertfordshire (Head Office)

Medical Affairs, Other

East Anglia, East Midlands, London, South East (Excluding London)

£Competitive

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Reference: 6835

A world-leading, research-based Pharmaceutical organisation are seeking a tenacious individual to join a small team of 4, working as a Senior Manager / Associate Director. This role will provide regulatory support on specific projects and queries relating to Chemistry, Manufacturing, and Controls (CMC) for small molecules and biologics products in development. Based from our clients Head Office in Hertfordshire, the successful candidate will lead and interact with all regulatory affairs departments, both internally and externally.

Essential Requirements
You will have extensive experience in the pharmaceutical industry, gained within Biologics.
Proven experience in CMC regulatory supporting new chemical entities and biologic products.
Working knowledge of the development and/or manufacture of small molecules and biologics (mAbs) compounds.
Experience of the development and manufacture of multiple dosage forms including process validation.
A good working knowledge of the analytical aspects relevant to small molecules and biologics (mAbs) including specification setting.
Experience in making regulatory submissions and dealing with regulatory agencies, preparation of briefing documents and holding agency meetings relating to CMC/Quality issues.
A Bachelor’s Degree (or equivalent with experience) in a Scientific or Technical Discipline; Advanced Degree (MSc. Ph.D, MBA) preferred.

Role Responsibilities
Provide CMC-regulatory support on specific projects/queries relating to CMC for small molecules and biologic products (primarily monoclonal antibodies (mAbs) in development from a global perspective and strengthen the science and scientific arguments made in the Quality section of all submissions (IMPDs/INDs, Briefing documents for scientific advice, BLAs/MAAs, variations etc.) made by the company.
Provide CMC expertise at Health Authority meetings.
Collaborates with IPT and CMC teams to advance development projects toward submission/approval.
Provide CMC input into Regulatory Submissions and Clinical Development Plans as well as pro-actively inform stakeholders of draft and new guidelines which could impact on current projects.
Ensures quality of deliverables and services to our clients’ Business units for multiple projects/product.
Take thorough measures to keep development projects away from regulatory risk.
Provides CMC regulatory consultation to project members.
Establish CMC regulatory strategy for projects/products.
Lead preparation of regulatory communication documents and materials.
Attend internal and Health Authority regulatory meetings to solve issues on CMC/Quality of the development projects.
Lead preparation of submission dossiers. This includes authoring of QOS.
Estimates changes proposed by QA/manufacturing and take necessary regulatory measures.
Evaluate CMC regulatory situation and propose solutions to make CMC activities more productive.

Role Specific Competencies
Sense of urgency
Strategic business thinking
Global organisational awareness
Team player
Leading change

Recruitment Process
2 stage process.

Salary
Highly competitive package + bonus / benefits.

Evolve Selection is a leading UK recruitment and contract sales organisation (CSO), operating within the Pharmaceutical, Healthcare and Medical Device sectors. We offer a highly comprehensive range of permanent recruitment and flexible contract sales solutions.

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