Head of Global Regulatory Affairs
This position will be a strategic leader developing a global regulatory strategy for the company portfolio. This position involves both high level strategic planning, direct interactions with regulators and partners as well as hands-on responsibilities. You will provide regulatory leadership through cross functional collaboration and will be responsible for the development and execution of the regulatory strategy. You will guide team decisions, oversee regulatory operations, and manage electronic submissions. You will ensure effective communications with representatives of the FDA and global health authorities.
This position will report to the Chief Medical Officer.
- Primary liaison with FDA and global health authorities.
- Regulatory representative in project teams leading regulatory strategy development and implementation.
- Provide regulatory oversight and guidance to project teams on compliance matters, health authority requirements, clinical study design issues, logistics, and operational recommendations for product development.
- Work pro-actively to partner with other functions to plan and execute an effective regulatory strategy in alignment with the overall clinical plan.
- Accountable for the development and submission of all regulatory documents (e.g., pre-IND and end of phase briefing books, INDs, responses to regulatory inquiries, IND Safety reports), IMPD content, pediatric development planning (PSP/PIPs), designations for expedited program development and/or special status submissions, NDAs, CTAs, MAAs, IND/IMPD maintenance activities, annual reporting, and safety submissions.
- Lead regulatory operations and submissions management by managing and providing vendor oversight.
- Lead the development of briefing documents and lead formal regulatory meetings with health authorities.
- Anticipate regulatory obstacles and emerging issues including changing regulations throughout the product lifecycle, develop solutions, and provide guidance to the cross-functional teams and senior management.
- Effectively communicate the regulatory strategy, risks, mitigations and overall plans to the project teams and Ribon Management Team as required.
- Establish and maintain excellent relationships with regulatory agency personnel.
- Ensure compliance with internal SOPs, regulations, and applicable laws.
- Monitor global regulatory changes that may impact asset development and corporate strategy.
Knowledge and Skill Requirements:
- B.S/M.S. in a scientific discipline; PharmD or PhD preferred.
- Minimum 10 years in life sciences industry-related experience with experience in Regulatory strategy.
- Advanced knowledge and experience in interpretation of regulations, guidelines and precedents related to drug development in the US and EU; APAC is a plus.
- Experience submitting INDs and NDAs/BLAs.
- Experience with CTD format and content regulatory filings.
- Expert knowledge of the current global regulatory environment.
- Deep experience & knowledge in all regulatory aspects of clinical development.
- Excellent verbal and written communication skills with ability to positively impact and influence peers and team.
- Experience managing complex schedules and priorities in dynamic environments; ability to conform with shifting priorities, demands and timelines through analytical and problem-solving capabilities.
If you are interested in joining Ribon’s team, please email your resume to [email protected]