Associate Director, Regulatory Affairs

Associate Director, Regulatory Affairs

POSITION SUMMARY

The Associate Director, Regulatory Affairs manages, evaluates and completes regulatory projects consistent with the company goals. Responsible for timely planning and coordination of regulatory submissions. Provides guidance to cross-functional teams on regulatory strategy and tactics. Keeps abreast of regulatory procedures and practices. The incumbent will work independently with appropriate oversight and is expected to identify and act on activities without requiring immediate direction.

ESSENTIAL FUNCTIONS

• With minimal supervision, plan and manage regulatory activities related to assigned development projects. Assist in developing and implementing strategies for the earliest possible approvals of regulatory submissions associated with assigned development projects.
• Manage the assembly and timely submission of 510Ks, INDs, BLAs and other dossiers as required for investigation and registration of drugs, biologics and devices in the US.
• Ensure regulatory submissions are maintained in compliance with regulatory requirements.
• Represent the company in its dealings with the FDA and other regulatory authorities, as appropriate.
• Participate on project teams and provide expertise on regulatory matters.
• Develop and maintain current regulatory knowledge and advise management of significant developments.
• Contribute to improvements in department best practices and SOPs.
• Perform other duties as required, interfacing with other departments, CROs, and external vendors as needed.

QUALIFICATIONS, EDUCATION AND EXPERIENCE

Education

• Bachelor of Science in a scientific discipline.
• Master of Science (preferred)

Basic Qualifications

• 5+ years direct Regulatory Affairs experience in the US market.
• Experience with drugs, biologics and medical devices.  Previous experience with combination products and/or botanicals a plus.
• Experience and knowledge in preparation of 510K’s, BLAs, INDs and supportive amendments and supplements.
• Experience with prescription drug advertising regulations and promotional review committee’s
• Experience with labeling and UDI regulations
• Working knowledge of FDA regulations and understanding of FDA structure and function.
• Working knowledge of eCTD elements and structure.
• Strong regulatory writing skills and use of Microsoft Word.
• Strong team player that has a customer service approach and is solution oriented.
• Attention to detail and the ability to work individually, within a multidisciplinary team, or with external partners and vendors.
• Possess excellent written and verbal communication skills.

WORKING CONDITIONS AND PHYSICAL DEMANDS

Occasional travel (5-10%)

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