Job description
Senior Director, Regulatory Affairs
Greater Boston
Description:
The Director/Senior Director, Regulatory Affairs is responsible for developing and executing the global regulatory strategy for the programs assigned. Reporting to the Head of Regulatory Affairs, this individual will develop and advance organizational policies and procedures, while also monitoring changes in the regulatory environment that may impact current or future program objectives.
Experience:
Greater Boston
Description:
The Director/Senior Director, Regulatory Affairs is responsible for developing and executing the global regulatory strategy for the programs assigned. Reporting to the Head of Regulatory Affairs, this individual will develop and advance organizational policies and procedures, while also monitoring changes in the regulatory environment that may impact current or future program objectives.
Experience:
- BA/BS degree in life sciences, advanced degree is a plus
- At least 12 years in the pharmaceutical industry, with a minimum of 8 years in regulatory affairs
- Well-versed in regulatory strategy, and regulatory writing
- Experience as primary regulatory author for of IND and CTA documents
- Experience in communicating regulatory strategy, submission documents and plans both internally and externally
- Lead the timely preparation, review, publishing and submission of documents to regulatory authorities, and maintain compliance with applicable regulatory requirements and best industry practices
- Provide strategic guidance and insightful interpretation of applicable global/regional regulations in support of regulatory milestones such as IND, CTA, NDA, MAA; regulatory agency interactions; etc.
- For the products assigned, lead and/or co-author the preparation of information packages for regulatory submissions; review these packages for conformance with established regulatory requirements and company standards
- Assess opportunities for expedited pathways, such as US Breakthrough Therapy Designation or Priority Medicines
- Effectively communicate with internal and external team members, senior leaders and key stakeholders on the status of, risks and mitigation plans associated with the regulatory milestones
- Coordinate with the appropriate in-house stakeholders the preparation of responses to queries from regulatory authorities and ensure timely submission
- Ensure regulatory commitments are addressed diligently, within the required timeframe.
- Support continuous improvement of existing department processes and strategies
- Keep abreast of regulatory guidance and technical/scientific developments relevant to projects. Contribute to commenting on draft regulations and assess future areas for influencing the regulatory environment
- Knowledgeable in ICH, FDA and EMA guidelines, and familiarity with GCP, GLP, GRP
- Extensive experience in working with regulatory health authorities such as FDA, EMA, Health Canada across all phases of clinical development; orphan drug experience is a plus
- Sound understanding of the scientific principles underlying the regulatory requirements
- Strong knowledge of eCTD elements and structure and regulatory writing skills
- Ability to work independently and thrive in a fast-paced environment
- Team player with the ability to be a situational leader when required
- Strong analytical and strategic thinking skills