Director of Regulatory Affairs

Global Life Science Hub partners with a forward-thinking New Jersey based biopharmaceutical powerhouse that is revolutionizing the life science industry. Their breakthrough innovations in oncology offer new hope to cancer patients, while their advancements in CNS disorders and infectious diseases bring relief to those facing challenging health conditions.

With a proven track record of successfully discovering and commercializing over 15 drugs, this industry leader pushes the boundaries of medical innovation. As the Director of US Regulatory Affairs, your role is to manage, design, and implement the U.S. regulatory strategy for the clinical-stage programs. You will also provide guidance on US regulatory strategy and filings.

Responsibilities:

• Direct and coordinate activities of assigned products within Regulatory Affairs, encompassing developmental products and post-marketing commitments, for a leading pharmaceutical company
• Serve as the primary contact for negotiations and interactions with regulatory authorities, including the FDA, providing guidance and strategy for ex-US strategy and filings.
• Contribute to the development of regulatory strategies to ensure efficient FDA review and approval times for regulatory applications.
• Offer regulatory guidance to the team during strategy formulation and preparation of submissions.
• Coordinate and collaborate with various departments to ensure regulatory documentation is comprehensive, consistent, and adheres to FDA standards for all submissions.
• Author and maintain IND and NDA applications, supplements, and annual reports as per established timelines and submission dates.
• Liaise with regulatory agencies on product-related regulatory issues, and participate in meetings and teleconferences, preparing briefing documents for health authorities.
• Critically review protocols, data, and reports for clarity, consistency, conformance to regulations, guidelines, and regulatory strategy, and suitability for submission.
• Assist in developing and implementing departmental policies and procedures, ensuring compliance with Company Standard Operating Procedures.
• Review and assess the Company's change controls in line with regulatory requirements.
• Prepare and submit reports to senior management as required.
• Provide regulatory evaluation and opinions on due diligence activities, and offer regulatory assessments to management.

Experience/Qualifications:

• Hold an M.S. degree in a life science or other relevant discipline, with preference given to candidates with advanced degrees.
• Possess a minimum of 5 years of relevant experience in drug or biologics development.
• Recent experience in the infectious disease, respiratory, GI, and/or pain therapeutic areas is a plus.
• Preferably have direct experience with CDER and hold RAC certification.
• Demonstrate thorough knowledge of FDA and international regulatory requirements.
• Have a proven track record of effectively managing multiple projects/activities and working in a team-oriented environment.
• Possess direct experience with successful NDA submissions.
• Be an energetic, results-oriented individual contributor and team player.
• Exhibit strong verbal and written communication skills to effectively communicate with employees at all levels, including the ability to conduct presentations.
• Possess strong analytical and technical writing skills.
• Demonstrate thorough knowledge and understanding of FDA and ICH guidelines.
• Have previous supervisory experience.
• Be willing and able to travel domestically and internationally up to 20% of the year, using various modes of transportation.
• Experience with eCTD submission software is useful, but not required.

Apply:

The Global Life Science Hub are a niche Life Science headhunting firm. We place professionals across Europe and the US for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.

If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.glshub.com