The role of the Director of Regulatory Affairs entails overseeing regulatory strategy and providing managerial support for the development of complex Injectable and Inhalation products in the extensive portfolio, emphasizing proficient execution. This position involves guiding and collaborating with R&D and HORA teams, reviewing ANDAs before or after submission, proactively addressing identified issues with cross-functional teams, and ensuring the timely submission of high-quality materials with a focus on securing first-cycle approvals. The Director will establish effective relationships with regional and functional regulatory colleagues to devise US submission strategies and offer support as required. Additionally, the candidate will engage in the early stages of product development to ensure that Complex Products' ANDAs contain sufficient information for expedited approval. The role also requires expertise in 505b(2) strategy and submissions, effective communication with the FDA, and a strong grasp of immunogenicity/sameness concepts.
- Oversee the development of complex injectable and inhalation dosage forms,
- Coordinate and execute regulatory strategies, and assist individuals at all levels in adopting appropriate approaches.
- Coordinate and review critical documents for submission to US regulatory authorities and engage with the FDA as needed to ensure the timely submission of high-quality materials.
- Establish productive relationships with US Regulatory authorities to guide the company in addressing specific issues and information requests.
- Conduct timely gap analyses and execution plans,
- Contribute to ongoing R&D projects,
- Prepare information and activities for regulatory agency meetings,
- Supervise designated Regulatory staff and conduct periodic performance evaluations
- Master's or PhD in physical, pharmaceutical, biological, or another life science field, with direct FDA submission experience
- A minimum of 12 years of hands-on regulatory experience, including 5 years in a managerial capacity. Additionally, 8-10 years of experience with a successful track record of submitting ANDA applications to the FDA.
- A history of interaction with the OGD Divisions of the FDA.
- Experience with complex generics products such as Injectable, Dermatological, Ophthalmic, and respiratory product/devices for the US market.
- Exceptional written and verbal communication and presentation skills.
- Proficiency in interpersonal skills and a proven ability to work with cross-functional, multinational teams.
- Strong skills in team management and development.