Lead the preparation of regulatory submissions to assure full compliance with all relevant requirements in the U.S. as well as in Europe, Canada, Japan and Australia.
- Provide strategic and operational input, guidance and oversight to global project teams to assure that regulatory submissions and all aspects of regulatory compliance support Boston Biomedical’s R&D objectives.
- Develop and create regulatory compliance strategies for multiple clinical development projects.
- Coordinate all aspects of the preparation, review and submission of regulatory documents. This includes the clinical and non-clinical portions of documents.
- Represent the Regulatory Affairs Department as a member of cross functional project teams and provide guidance relating to changing global regulatory requirements.
- Serve as the Company’s Regulatory Affairs Lead in interactions with global health authorities including the FDA, EMA, MHRA, Health Canada and ROW with respect to clinical submission documents.
- Provide leadership and direction in the development of clinical regulatory documents including INDs, CTAs, BLAs, DMFs, NDAs and MAAs.
- Make submissions to global regulatory authorities, as required, and maintain an ongoing interactive relationship regarding these submissions.
- Coordinate and maintain reporting schedules for regulatory applications.
- Assure that all aspects of the Company’s regulatory activities are conducted in full compliance with applicable regulations and at the highest level of ethical standards.
- Create and maintain Regulatory Strategic Development plans and provide strategic input in global product development planning.
- Identify and communicate to executive management information about potential regulatory issues; propose risk evaluations and mitigation strategies.
- Mentor and help develop the strategic & technical expertise of regulatory colleagues who are involved in supporting filings.
- Bachelor’s degree in a relevant scientific discipline. Master’s or an advanced degree (PhD, PharmD) is preferred.
- 10-15 years of regulatory affairs experience in the pharmaceutical industry.
- Understanding of global regulatory submissions including compliance with FDA, EMA, ICH and ROW clinical and preclinical regulatory requirements.
- Relevant filing experience (INDs and NDAs) in leading negotiations and Health Authority interactions as well as FDA Advisory Committee Meetings (e.g. ODAC). Experience with regulatory filings in oncology is preferred.
- Strong written and oral communication skills and the ability to interact effectively with project teams.
- Ability to manage regulatory affairs activities and provide leadership in a “hands-on fashion” while utilizing a strategic approach in all aspects of global compliance.
Job Location: Cambridge, MA
Please send resumes to email@example.com