Senior Director Regulatory Affairs CMC
.Successful candidate will be responsible for leading the RA CMC department and developing and executing global regulatory CMC strategies for the companies investigational and commercial oncology and rare-disease assets.
- Head of Regulatory CMC responsible for leading and developing the RA CMC staff.
- Work cross functionally to develop and execute global CMC regulatory strategies for investigational and commercial products.
- Coordinate, author and/or review submissions of initial INDs, CTAs, NDAs, MAAs, amendments and Agency meeting briefing documents.
- Coordinate responses to questions from health authorities.
- Provide regulatory evaluation of CMC change controls.
- Represent Regulatory CMC in interdisciplinary teams (specifications/stability/change review) and project teams.
- Provide interpretation of regulatory guidance documents, regulations and directives.
- Provide input on CMC topics to external partners.
- Communicate critical topics, risk and remediation plans to appropriate management level.
Skills and Requirements:
- Master's degree with at least 12 years of experience in regulatory in the pharmaceutical/biotech industry.
- Late stage/NDA development experience.
- Strong knowledge of current US and EU regulations and guidances, Good Manufacturing Practices (cGMP).
- Ability to effectively organize and prioritize tasks to set and achieve deadlines.
- Strong verbal and written communication skills.
- Strong knowledge of eCTD elements and structure and regulatory writing skills.
- Strong general technology skills.
- Strong project and submission management skills.
- Demonstrated ability to work effectively through cross-functional team to achieve results.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nicholas Walker at (+1) 646-367-2908 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.