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Director Regulatory Affairs

Apply knowledge of current applicable regulatory requirements and precedents to inform regulatory guidance and requirements for externally facing materials for investigational and planned commercial products and provide updates to project teams and/or functional area leads, as needed. Provide regulatory leadership and expertise to the Medical Review Committee (MRC) and Medical, Legal and Regulatory (MRL) Promotional Review Committee with a focus on review and approval of externally facing communications for investigational and planned commercial products.

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<div>Position Overview: The Sr. Director, Regulatory Affairs US Advertising and Promotion will provide regulatory leadership to advance the development and planned commercialization of innovative therapeutic products.The successful candidate will report to the Sr. Director, Regulatory Affairs and lead regulatory guidance and review of externally facing communications for investigational and planned commercial products.Responsibilities:<ul><li style="line-height:normal">Provide regulatory leadership and expertise to the Medical Review Committee (MRC) and Medical, Legal and Regulatory (MRL) Promotional Review Committee with a focus on review and approval of externally facing communications for investigational and planned commercial products. </li><li style="line-height:normal">Serve as the primary regulatory liaison to Commercial, Medical Affairs, Legal, etc. to assure our practices are compliant with current regulatory standards.</li></ul>·Oversee the development and execution of regulatory strategies and processes as it relates to US advertising and promotional materials.·Perform critical data assessments to enable timely and effective preparation, review, and submission of key US regulatory advertising and promotional material. <ul style="margin-top:0in"><li style="margin-bottom:0in;line-height:normal;background:white;vertical-align:baseline">Draft and manage regulatory submissions related to advertising and promotional materials</li><li style="margin-bottom:0in;line-height:normal;vertical-align:baseline">Apply knowledge of current applicable regulatory requirements and precedents to inform regulatory guidance and requirements for externally facing materials for investigational and planned commercial products and provide updates to project teams and/or functional area leads, as needed. </li><li style="margin-bottom:0in;line-height:normal;vertical-align:baseline">Monitor for new regulations, guidance, enforcement priorities and trends, and advise project teams and functional area leads of significant developments.</li></ul>Requirements: Education and Experience:<ul><li style="line-height:normal">Advanced or bachelor’s degree in a scientific discipline; life sciences preferred </li><li style="line-height:normal">Minimum of 12 years of experience working in a regulated life science environment (pharmaceutical, biotechnology); 7 years or more experience working within Regulatory Affairs US Advertising and Promotion</li><li style="line-height:normal;background:white">Advanced working knowledge of Advertising, Promotion and Labeling regulations, guidance and OPDP required </li><li style="line-height:normal;background:white">Experience providing regulatory assessment for promotional review committee in preparation for US commercial launch </li><li style="line-height:normal;background:white">Experience with establishing promotional review process for product launch preferred</li><li style="line-height:normal">Experience with Veeva PromoMats a plus</li><li style="line-height:normal">Demonstrated hands on experience with drafting and managing regulatory submissions related to advertising and promotional materials</li><li style="line-height:normal">Prior FDA/OPDP regulatory liaison experience required</li><li style="color:#333333;margin-bottom:0in;line-height:normal;background:white;vertical-align:baseline">Collaborative and solution-oriented mindset and approach</li><li style="line-height:normal">Experience with monoclonal antibodies and neurodegenerative and rare diseases preferred</li></ul>Competencies and Attributes:•Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Company’s culture and values - courageous, imaginative, selfless, and joyful•Excellent collaboration, review and organizational skills, including the ability to support and prioritize multiple projects, as needed•Must display strong analytical and problem-solving abilities and decision-making skills.•Excellent communications skills: oral, written, negotiation skills, and strong time management. Effective in interactions with commercial and medical affairs leaders.•Demonstrated competence in understanding and effectively applying current regulatory requirements in an emerging regulatory landscape•Ability to build and maintain effective internal and external relationships, including cross-functional teams and contract research organizations/consulting agencies</div>

Clinical Dynamix, Inc.

Senior Director, Regulatory Affairs US Advertising and Promotion

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Clinical Dynamix, Inc.