Senior Director, Regulatory Affairs (Inhalations – ANDAs and 505 (b)(2))

The Senior Director of Regulatory Affairs is responsible for establishing regulatory direction and providing management support for the US development of complex Inhalation products within Lupin’s complex portfolio, with a robust execution skill set. This individual is responsible for guiding and coordinating with R&D and HORA, reviewing ANDAs pre- or post-submission, proactively working with cross-functional teams, including marketing, to resolve any outstanding issues identified, and ensuring timely, high-quality submissions to focus on first-cycle approvals.

The Senior Director will build solid, effective relationships with peers and staff from other regional and functional regulatory bodies to develop US submission strategies and provide support as needed. The candidate will get involved in the early stages of product development to ensure that the ANDAs with good experience in Complex Products have sufficient information to support a quicker approval. This role should also have the capability to implement 505b (2) strategies and submissions, a strong communication strategy with the FDA, and additional strong expertise in the Medical Device area, and the ability to understand the PK/PD strategy.

This position supervises Regulatory personnel as required. Further, it supports all the Regulatory aspects of the Company’s generic businesses.

Essential Duties and Responsibilities

• Products include assets being developed for Inhalation dosage forms and others as designated.
• The individual is responsible for developing, coordinating, and executing regulatory strategies and for guiding others at all levels on appropriate approaches. Responsible for the coordination/review (all critical) of documents for submission to US regulatory authorities
• The individual will interact with the FDA as needed and provide support for regulatory filings and ensure timely and high-quality submissions.
• Responsible for establishing productive working relationships with the US Regulatory authorities, providing guidance to the company by addressing specific issues and information requests.
• Conduct gap analyses and execution plan in a timely manner.
• Responsible for establishing and maintaining engagement with cross-functional teams to complete the tasks.
• Understand and contribute scientifically to ongoing R&D projects.
• Drug development experiencerequired(CMC and PK/PD Clinical development)
• Responsible for the preparation of information and related activities for meetings with drug regulatory agencies, as well as the conduct of meetings and the preparation of accurate meeting minutes.
• Provides support for due diligence activities associated with business development as required.
• Supervise assigned Regulatory staff and conduct periodic performance evaluations in accordance with organizational structure.
• Perform other duties as assigned.
• Excellent verbal and written communication skills (including technical writing and editing skills) are essential. Mustpossessgood oral and written English language skills

• MS or PhD in physical, pharmaceutical, biological, or other life sciences. An advanced degree is a plus.
• A minimum of 10 years of hands-on regulatory experience, with 5 years in a management role. Further, 8-10 years of experience with a successful record of submissions and approvals of ANDA/NDA (505B2) applications to the FDA.
• A history of interaction with the OGD/OND Divisions of the FDA as well.
• Experience with complex generics products such as respiratory products/devices for the US.
• Excellent written and verbal communication, presentation skills are required.
• Good interpersonal skills and experience working with cross-functional, multinational teams.
• Strong team management and developing skill set.

Physical Requirements

The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment.

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