Senior Director / Director, Regulatory Affairs (Women’s Health) – Top $/Will Relo (Remote Option)
Our client, a leading provider of oral and emergency contraceptives in the US, is building its development team and actively recruiting for a highly knowledgeable, capable and mission-driven candidate to lead its Regulatory Affairs function.
The company is committed to developing and distributing reliable and affordable reproductive and sexual healthcare to all communities. To date its product portfolio has been driven by key partnerships and alliances. It is now developing its own products and this Regulatory Director will be instrumental in driving strategy and ensuring success. This is a critical role and company is prepared to offer a generous compensation package to attract and retain the right candidate.
Key Things to Note:
- The company currently has 2 products in development – both injectables– with several others under review.
- This Director will be responsible for all aspects of Regulatory Affairs, with particularly focus on submissions and strategy.
- Typically, this company will be submitting applications to the FDA Division of Urology, Obstetrics and Gynecology (DUOG).
- This position will begin as an independent contributor, directing the work for cross-functional teams, including external consultants. Supervisory responsibilities anticipated in the future.
- This company, which was established in 2008, has a start-up vibe. It has created an inclusive and empowered environment in which smart, resourceful, flexible, collaborative, focused (and kind) employees will thrive. This is a wonderful opportunity for those who bring similar qualities and values.
- This company is in Charleston, SC. The company is open to candidates can be onsite full-time (relo provided) but will also consider excellent remote candidates who can travel to Charleston as needed..
- Develop and lead global Regulatory strategy for drug development, clinical trial submissions, label expansions, registration submissions, and post-marketing activities.
- Lead creative and constructive interactions with US FDA to ensure that all projects have clearly defined regulatory paths and milestones leading to successful filings and approvals.
- Develop and execute regulatory plans, including oversight of and participation in the effort to ensure timely regulatory submissions for Company products (including INDs, ANDAs, NDAs, CTAs, 501(k)s, PMAs).
- Develop and maintain external relationships with potential partners, contract organizations, and regulatory agencies
- Provide direction and interpretation of regulatory requirements, regulatory intelligence, and benchmarking information
- Direct the development of systems, practices, and processes to ensure effective communication and execution of regulatory practices
- Ensure Regulatory team infrastructure is up to date and fit for purpose, including oversight of consultants (strategic direction, contracts, budget) as required.
- Lead general regulatory compliance, including local and federal licensure, promotional compliance, and maintenance of regulatory policies and procedures.
- Participate in FDA facility inspections, as needed, in support of Regulatory Affairs.
- Actively participate in cross-functional company meetings and activities, e.g., drug development, commercial launch, strategic planning, and business development.
Targeted candidate will offer a related scientific degree and 10+ years of industry experience with particular expertise in Regulatory Affairs strategies and tactics.
Other priorities include:
- Demonstrated ability to drive the work of cross-functional teams, including external consultants
- Direct experience interacting with the FDA;
- Substantial knowledge of U.S. Pharmaceutical and/or Medical Device regulations, standards, policies, and guidance documents
- Success moving products from IND/ANDA to regulatory approval
- Outstanding project management skills, including ability to juggle simultaneous projects with sometimes overlapping deadlines
- Superb verbal and written communication skills
- Track record of impact, growth and longevity; start-up experience preferred
Finally, we seek a hands-on, make-things-happen leader who brings ingenuity and initiative to the workplace every day and is committed to this company’s mission of providing accessible and reliable healthcare to all.
This is an immediate need. Please forward Word resume for prompt consideration.