Senior Specialist, Regulatory Pharmacologist-Promotions

About the role

The Senior Specialist Regulatory Pharmacologist - Promotions is responsible for the review and contribute to the approval of all US promotional materials and serve as the promotional regulatory consultant interacting with marketing, legal, and medical teams and as a member of the promotional review committee to ensure that promotional practices are consistent with regulatory guidelines, our company's policies, and support business objectives.

Responsibilities

• Contribute to the management of correspondence with FDA’s promotional review divisions Office of Promotion and Advertising Review (OPDP)/Advertising and promotional labeling branch (APLB), including complex regulatory questions and submissions for advisory comments.
• Contribute to the proposal of creative, effective, and compliant regulatory strategies and solutions to challenging promotional concepts that meet business objectives and minimize regulatory risk.
• Contribute to the development and implementation of US marketing strategy and promotional programs.
• Support the US commercial teams, including relevant stakeholders, by participating in strategy discussions and extended team meetings and providing regulatory guidance and perspective on marketing strategies and promotion objectives and tactics.
• Provide promotional regulatory input on concepts and draft materials to help ensure promotional materials are aligned with U.S. promotional regulations, corporate standards and policies and business objectives.
• Maintain current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters and policy issues affecting the pharmaceutical/biologics industry.
• Communicate significant changes in FDA perspective to relevant stakeholders
• Contribute to the development of departmental strategic initiatives to drive effective, compliant promotional regulatory review.
• Create, edit and adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates.
• Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities.

Requirements

Bachelor’s degree with an emphasis in science, health care or related fields with 7+ years of pharmaceutical/biologics industry or related experience with an emphasis in regulatory science or scientific disciplines (pharmacology/immunology/oncology) required; OR Master’s degree with an emphasis in regulatory science, health care or related fields with 5+ years of pharmaceutical/biologics industry or related experience with an emphasis in regulatory or scientific disciplines required; OR PhD or PharmD degree with an emphasis in regulatory science, health care or related fields with 3+ years of pharmaceutical/biologics industry or related experience with an emphasis in regulatory or scientific disciplines required. 3+ years of direct experience as the primary reviewer of advertising and promotional materials required.

Skills

• Demonstrated knowledge of FDA regulations relating to advertising and promotion for prescription products.
• Demonstrated history of successful interactions with the promotional review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for a product filing/launch.
• Excellent verbal and written communication skills
• Attention to detail and ability to manage multiple priorities simultaneously.
• Strong interpersonal skills with ability to demonstrate strategic and analytical thinking.
• Strong knowledge of pharmacology, immunology, or oncology, and related health authority regulatory requirements and guidelines is preferred.

Benefits

• Medical, Dental and Vision Plan Options
• Health and Financial Wellness Programs
• Employer Assistance Program (EAP)
• Company Paid and