Associate Director Regulatory Affairs
Associate Director, Regulatory Affairs
This individual is expected to provide strategic leadership within Regulatory Affairs. This person will serve as the Regulatory department representative on relevant project teams, and as the Regulatory contact with FDA and other regulatory authorities.
Duties and Responsibilities:
• Responsible for representing the regulatory function a the core team level
• Responsible for the development of global regulatory strategies
• Accountable for the implementation and execution of global regulatory strategies
• Accountable for regulatory submission of IND’s, CTA’s and other major regulatory submissions (e.g. NDA’s, BLA’s and MAA’s)
• Responsible for the submission content and labeling content
• Responsible for leading interactions with the FDA and other Regulatory Agencies’ as required
• Leads the Regulatory subteam in most cases and is accountable for escalating issues to upper management, evaluating regulatory risks and developing mitigations plans in close cooperation with regulatory senior management
Experience: A minimum 4-year degree in a scientific or technical discipline; advanced degree preferred. Must have a minimum of 7-9 years experience in Regulatory Affairs or equivalent experience within the pharmaceutical industry.
Previous experience in leading submission teams for marketing application and/or clinical trial applications is also required.
Other qualifications: Management experience is a plus. Must demonstrate a solid working knowledge of drug development process and knowledge of FDA regulatory requirements. Knowledge of EU, Canada, ROW and Post-marketing a plus. Direct experience in interacting with regulatory authorities; experience interacting with DDMAC is a plus. Candidates must be able to influence others and demonstrate strong project management, problem-solving, negotiating, interpersonal and communication skills (both written and oral).