Senior Manager, Regulatory Affairs Advertising and Promotion - Cell Therapy Products

职位描述

EXAMPLE RESPONSIBILITIES:

• Provides commercial regulatory support to high-volume brands or therapeutic area and projects with minimal managerial oversight, as appropriate. Reviews and approves promotional materials.

• Serves as the commercial regulatory lead for one or more high-volume brands or oncology therapeutic areas.

• Maintains a continued awareness and understanding of FDA regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products.

• Serves as regulatory liaison to FDA/CBER/APLB for assigned products, with managerial oversight.

• May initiate and/or contribute to local or global process improvements for activities relating to the work of RA Ad/Promo.

• Provides regulatory guidance on new marketing concepts, messages, and campaigns, with managerial oversight as needed.

• Represents RA Ad/Promo at Regulatory Project Team meetings.

• Represents RA Ad/Promo at labeling meetings and provides strategic regulatory guidance, with managerial oversight, as appropriate.

• Seeks assistance from others as needed.

• Mentors RA Ad/Promo team members and provides training to cross-functional team members as needed.

• Ensures own work complies with established practices, policies, and processes, and any regulatory or other requirements.

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Basic Education & Experience

• PharmD/PhD 0+ years’ relevant experience.

• MA/MS/MBA with 6+ years’ relevant experience.

• BA/BS with 8+ years’ relevant experience.

Preferred Requirements

• For external candidates, 2+ years’ experience in regulatory review of promotions for prescription drugs or other biologic products.

• Experience leading development and execution of regulatory submissions of promotional materials for prescription drug or biologic products.

• 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 is strongly preferred.

• Experience chairing/leading promotional review committees or other relevant regulatory governance committees is strongly preferred.

• Experience working directly with regulatory agencies in regulatory submissions and negotiations is a plus.

• Experience working with external contractors supporting the work of regulatory affairs is a plus.

• Experience authoring and/or implementing processes.

• Experience successfully leading departmental and cross-functional teams without authority.

• Demonstrated ability to be a fast learner.

• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.

• Demonstrates knowledge of the role of regulatory affairs in achieving cross-functional business goals and objectives.

• In-depth knowledge of regulatory requirements and guidance for the promotion of prescription drug and biologic products, including industry best practices and standards.

• Working knowledge of relevant regulatory or related systems is preferred.

• Demonstrates strong analytical thinking skills, attention-to-detail, strong communication and writing skills, and project management skills, as evidenced through accomplishments in past roles.

• Ability to lead and influence programs, projects and/or initiatives.

• Strong interpersonal skills and understanding of team dynamics.

• Proven ability to work successfully in a team-oriented, highly matrixed environment.

• When needed, ability to travel.