Our client is a clinical-stage biopharmaceutical company developing treatments for rare and ultra-rare genetic diseases. They are seeking a Vice President of Regulatory Affairs to develop and lead regulatory strategies for drug development and product registration. In this role you will lead interactions with the FDA and global health authorities to advance life-saving programs through the pipeline. Reporting directly into the Chief Medical officer, you will oversee all regulatory activities and build out the regulatory affairs and compliance team. This is an exciting opportunity to advance your career and take this company to the next level.
Responsibilities:
- Work with the CMO in developing regulatory strategies for development programs.
- Oversee all regulatory activities from Pre-IND meetings through marketing authorization and post-approval.
- Create and execute regulatory plans and manage timelines to achieve program goals.
- Interface directly with regulatory agencies and product development teams to facilitate the review and approval of regulatory applications.
- Responsible for the preparation and submission of required documents to regulatory agencies.
- Establish and maintain an archive of documents supporting regulatory filings.
- Develop and maintain strong and effective relations with internal/external personnel.
- Work closely with cross-functional teams to ensure that all activities are conducted in compliance with relevant laws, regulations, and guidance. Ensure clear communication of project activities and progress in a timely manner.
- Develop corporate quality systems and oversees compliance with GCP, GMP, GLP regulations, FDA and other health authority requirements and ICH guidance.
Knowledge and Skills:
- Bachelor’s degree in scientific field, advanced degree (MS or PhD) preferred.
- 12+ years of experience in regulatory affairs providing regulatory guidance in the development of drugs and/or post-marketing support of drugs
- Expert knowledge of FDA /EMA and ROW (rest of world) regulations and guidance documents.
- Demonstrated management and leadership skills working in a team environment
- Strong writing skills
- Direct experience in preparation of all major regulatory filings and supportive amendments of supplements.
- Well-developed communication abilities in support of proposing complex development strategies with globally diverse leadership team(s).
- Must have a high emotional IQ and ability to create solutions to
- Working knowledge of regulations pertaining to global regulatory agencies.
- Must have knowledge of GXP requirements and regulations as well an understanding of the pharmaceutical product life cycle.
- Experience with regulatory CMC filings is desirable
- Demonstrated ability to manage multiple assignments, appropriately identify and resolve regulatory issues, and communicate as needed to management.
- Demonstrated ability to work independently and manage multiple projects within cross-functional teams.
- Strong negotiation, communication and interpersonal skills and ability to deal effectively with a variety of personnel including medical, scientific, and drug development staff.