Job description
The Associate Director is responsible for the development and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional practices are consistent with regulatory guidelines and support business objectives. The individual is also responsible for leading and/or contributing to the planning, coordination, and execution of other post approval regulatory submissions.
The successful candidate will interface cross-functionally in a matrixed environment to integrate commercial Regulatory plans and ensure planning, coordination, and communication to develop timely and robust regulatory strategies and submissions to meet overall program objectives/milestones.
Some travel required, as needed.
Key Responsibilities
Experience managing commercial regulatory strategy and labeling function required
Significant experience contributing to the development of commercial regulatory or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional teams for multiple products.
The successful candidate will interface cross-functionally in a matrixed environment to integrate commercial Regulatory plans and ensure planning, coordination, and communication to develop timely and robust regulatory strategies and submissions to meet overall program objectives/milestones.
Some travel required, as needed.
Key Responsibilities
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- Responsibility for defining commercial regulatory strategies, ensuring that all corporate communications are compliant with regulatory standards.
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- Provides regulatory guidance on new marketing concepts, messaging, and campaigns.
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- Reviews and approves all US promotional materials working closely with cross-functional teams to ensure compliance with regulatory requirements and alignment with U.S. promotional regulations, corporate standards and policies and business objectives.
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- Management of the strategy and operational aspects of regulatory labeling for Phase 3 and commercial assets, ensuring that all labeling is accurate, compliant, and effectively communicates the necessary information to healthcare professionals and patients.
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- Serve as the liaison and manage correspondence with FDA’s promotional review divisions and provide input on application labeling negotiations.
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- Additionally, leading the strategy, coordination and execution of post approval regulatory submissions (e.g., phase 3b/4 studies, amendments, aggregate annual reporting etc.)., ensuring that all submissions are timely and meet the expectations of regulatory agencies.
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- Maintains a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products.
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- Lead the development of Regulatory Affairs SOPs relevant to commercial procedures.
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- Represents RA Commercial at Regulatory team meetings as well as to stakeholders and cross-functional team members.
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- Master’s degree or other advanced degree in life sciences, 10+ years working within the biotech/pharmaceutical industry, and 5+ years of Regulatory Ad/Promo experience required
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- Ability to lead matrixed teams, drive and influence effective collaborations.
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- Strong scientific writing and oral communication skills with ability to summarize clearly and succinctly and tailor messaging to target audience.
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- Experience working directly with regulatory agencies in regulatory submissions and negotiations is a plus
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- Initiative-taking, self-disciplined, and able to function independently as well as part of a team.
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- Proficient in various computer applications such as MS Project, Office suite, Smartsheet, etc.