Senior Manager/Associate Director, Regulatory Affairs

Job: Senior Manager/Associate Director, Regulatory Affairs

Location: Florida/ Remote

Reports to: Senior Director

Our client is currently on the lookout for a Regulatory Affairs expert to be responsible for their US division.

Key Responsibilities

• Help with regulatory requirements and prepare regulatory submission for all new/modified combination products, drugs, and medical devices. These submissions can include but not be limited to IND’s, BLA’s, meeting packages and expediated programs. These submissions can include but not be limited to 510 (k)s, IDEs, and PMAs as well as INDs and BLAs
• Ensure timely preparation of high-quality regulatory documentation and dossiers.
• Lead interactions with regulatory authorities, including setting meeting objectives, preparing briefing materials, coordinating internal rehearsals, and managing risk-mitigation plans.
• Collaborate closely with cross-functional teams to integrate regulatory considerations into program plans and ensure alignment with overall development timelines and objectives.
• Present and defend regulatory strategies in project team meetings and with external partners.
• Work with internal functions to ensure compliance with regulatory standards and support audit/inspection readiness.
• Maintain up-to-date knowledge of relevant regulatory guidelines, global requirements, and the evolving competitive landscape.
• Provide support across additional regulatory or program activities as needed.

Qualifications

• Bachelor’s Degree/ Master's degree in Life Sciences, Engineering or related field
• 5+ years in a regulatory capacity with Oncology experience
• High degree of understanding of regulatory requirements, how they operate, how to obtain updated information and where to obtain interpretations of them
• Ability in authoring regulatory documents such as M1, M2 of an IND, IND amendments, response to regulatory agency’s IR, expediated program applications.
• Ability to inform and educate managers and department heads on regulations and policies that require compliance
• Ability to translate regulatory requirements into practical, workable plans
• Proficient with Microsoft Office Suite or similar software
• Proficient with applicable database and compliance software
• Must be able to juggle multiple and competing priorities

Offer:

• Competitive salary ($150-180k)
• Professional development and potential for upward career growth.
• Impact in shaping regulatory strategy.