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Sr. Manager, Regulatory Affairs - Advertising & Promotion
Our client is looking to add a Sr. Manager, Regulatory Affairs – Advertising & Promotion to their team on a permanent basis. The person in this role will provide a regulatory review of communications about client’ s marketed products and disease areas to healthcare providers, patients, payers, and other audiences, with the objective of ensuring they comply with U.S. laws and regulations and company policies while supporting the achievement of business objectives.
- Collaborate with colleagues in Commercial, Legal, Medical Affairs, and other expertise areas in the creation of promotional and disease awareness communications, field training materials, and materials and communications used in scientific exchange, for assigned product(s)
- Provides expert guidance to help evaluate and mitigate potential risks.
- Serves as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products.
- Establishes relationships with management and key partners (Marketing, Medical, Legal, Compliance, Sales Training, Managed Care, Corporate Communications, etc.) encouraging mutually helpful interactions and exchange.
- Maintains awareness of labeling updates to communicate impact and relevance within Regulatory Organization.
- Highlights important facts in a clear and concise manner.
- Develops and guides implementation strategies for promotional activities
- Broadly applies regulatory/technical knowledge of government regulations and skills across therapeutic areas.
- Ensures training and compliance with established regulations, guidance, promotional guidelines, and SOPs related to advertising and promotion regulations.
- Effectively delivers difficult messages to cross-functional partners without damaging relationships.
- Prioritize workload based on Business Unit needs and ensure timely and complete submissions.
- Provides product development and label development strategies, as needed, to ensure promotional claims can be supported
- Mentors student interns and PharmD Candidates by leading projects during internships and rotations to help provide an impactful and meaningful experience in the pharmaceutical industry
- Provides expert guidance to help develop material review processes for cross-functional teams and high visibility materials
- Develops labeling materials specific to advertising and promotion, such as DTC and HCP Brief Summaries, to expand the commercial advertising capabilities for approved products
- Presents regulatory and compliance training to company representatives and speaker bureau prior to medical conference exhibit, speaker programs, and similar interactions
- Consistently evaluates regulatory landscape and industry promotional standard to develop best practices for consistency across business units
- Initiates and/or contributes to process improvements for activities that relate to the RA Ad/Promo group and the broader organization
- Work closely with Regulatory Operations in making timely submissions of promotional materials to FDA Provide Regulatory Strategy and Global Labeling colleagues with input into clinical study designs and labeling claims that will support commercial objectives
- Participate in educating the organization on the U.S. regulatory framework and enforcement environment for advertising and promotion of prescription drugs and biologics
Requirements / Qualifications:
- A Bachelor' s degree in science (BS) required. Advanced degree (PharmD, PhD, or JD) preferred.
- Minimum of 5-7 years of professional experience in the biopharmaceutical or related industries, with at least 3 years of Regulatory Affairs advertising and promotion experience. (Fellowship experience may be substituted)
- Knowledge of U.S. laws, regulations, guidance documents, enforcement actions, and industry standards related to communications about prescription drugs and investigational treatments
- Understanding of clinical study design and statistical analyses, and their importance in the assessment of claims Strong interpersonal skills
- Must be solution-oriented and embrace company’ s culture and approach to product communications
- Must be detail-oriented and able to manage multiple priorities
- Skilled in written and verbal communications
- Proficient in Microsoft Office
- Professional, proactive demeanor
- Strong interpersonal skills