The Director, Regulatory Affairs is primarily responsible for developing, coordinating and implementing regulatory strategies for new product development registrations, postmarketing change and maintenance requirements, and licensing opportunities. The Director will work on strategizing filings to meet company objectives, be responsible for troubleshooting discrepancies between products and regulatory requirements, and proactively planning for changes in FDA and EU regulations and requirements.
Major Areas of Responsibility
- Collaborate with senior management, Product Development, Clinical Operations, Manufacturing and Quality to develop, coordinate, and implement regulatory strategies for new product development registrations, marketed products, and licensing opportunities.
- Work with development teams to develop strategies for regulatory submissions.
- Generate and execute regulatory submission plans, and direct document development, review, and finalization.
- Oversee the preparation, approval and submission of all sections of all filings to regulatory authorities, including, but not limited to, IND, NDA, CTA and MAA applications.
- Other duties as required.
Minimum Job Qualifications
- PhD/PharmD with 7+ years experience in Regulatory Affairs or BS/MS/MSN with 10+ years' experience.
- Experience in a successful leadership role in managing, developing and registering candidate drugs through regulatory product approval and commercialization.
- Extensive experience in working directly with the FDA. In-depth knowledge of FDA regulations, knowledge of CTD/eCTD, and all regulatory requirements for FDA and EU submission requirements.
- Must have ability to develop both short and long term strategic plans, as well as demonstrated abilities to execute such plans successfully.
- Superior scientific writing skills for developing regulatory documents
Preferred Job Qualifications
- Drives implementation of department's strategy in alignment with Manufacturing Operations, Quality, Clinical Operations, Compliance and company goals. Understands the regulatory environment for pharmaceutical companies, as well as pharmaceutical industry regulatory affairs best practices to satisfy regulatory requirements.
- Proactive, creative, forward-thinker with the ability to think innovatively about integrated global strategy for regulatory, reimbursement and patient care, while accurately anticipating future consequences and trends.
- Ability to engage regulators on new approaches and implement new strategies for product regulatory filings.
- Experience with small and large molecule drug substance, solid oral drug products and drug-device combination products.
- Develops and maintains strong collaborative internal and external working relationships.
- International regulatory experience (e.g., EU and/or Canada).
- Experience working the Division of Rare Diseases and the Division of Neurology Products at the FDA preferred.
Skills & Abilities Required
- Possesses a thorough knowledge of current FDA regulations and guidances of requirements for investigational products, IND/NDA submission requirements, and post approval manufacturing changes. Must be able to generate regulatory strategies to provide leadership to multidisciplinary teams.
- A track record of successful interaction with regulatory agencies, as demonstrated by timely submissions and approvals of pharmaceutical products.
- Possesses leadership skills and ability to interact with senior management, and to work with outside vendors and partner companies.
- Must be a demonstrated self-starter and team player with strong interpersonal skills. Must be a hands-on player.