Associate Director/Director, Regulatory Advertising Promotion

Job Description

Responsible for actively contributing to the development and implementation of regulatory strategy for promotional labeling as well as serving as the regulatory lead on review teams for promotional and medical materials.

A. Essential Functions:

• Actively contribute to the development and implementation of regulatory strategy for promotional labeling and other communications including social media, press releases and talking points

• Regulatory lead on the Promotional Review Committee for assigned products

• Coordinate all aspects of AP regulatory submissions including promotional materials and pre-use submissions for subpart E&H products as needed

• Provide regulatory representation to early stage programs, including review of DSMR materials as needed

• Prepare and deliver effective presentations for external and internal audiences.

• Represent US Ad-Promo on global regulatory teams

• Supervise and mentor direct reports if applicable

• Participate in industry groups

• Comment on draft guidancesissued by FDA

• Represent Ad-Promo on cross-functional teams

• Actively contribute to the development and implementation of regulatory training programs for cross-functional partners

B. Additional Functions:

• Contribute to organizational effectiveness.

• Maintains optimism and energy in the face of change and adversity.

• Effectively serve as a role model within regulatory and cross-functionally.

• Ability to impact industry and agency organizations.

• Ability to step in for Director as needed.

• May have direct reports.

Qualifications

• Minimum 8+ years pharmaceutical/Biotechnology industry experience, 6+ years regulatory advertising and promotion experience.

• Ability to work both independently with minimal direction and within teams to attain group goals.

• Demonstrate excellent communication skills.

• Demonstrate effective cross-cultural awareness and capabilities.

• Demonstrate strong organizational skills, including the ability to prioritize workload.

• Strong interpersonal skills and the ability to deal effectively with a variety of staff including commercial, medical, scientific and manufacturing staff.

• Knowledge and understanding of applicable regulations.

• Experience in interpretation of regulations, guidelines, policy statement related to product labeling, promotions and other communications.

• Direct experience with regulatory agencies

• Computer literate

• Sensitivity for a multicultural/multinational environment

Education :

BA/BS/University Degree required, Life/Health Sciences preferred



Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.

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