AbbVie Associate Director, Regulatory Affairs Advertising & Promotion in California, United States
Associate Director, Regulatory Affairs Advertising & Promotion
GENERAL POSITION SUMMARY/PURPOSE:
Provides regulatory guidance in the development and approval of compliant advertising and promotional materials, disease state education, field training materials, and external communications on unapproved products or indications under development. Evaluates materials to ensure compliance with FDA regulations, guidance, and Pharmacyclics corporate policies. Conducts a detailed review and evaluation of the adequacy of clinical evidence provided to support proposed claims, assesses consistency of proposed claims with FDA approved labeling and delivers consistent, well-supported, and clear guidance.
This position must be capable of representing the commercial regulatory perspective at and chairing the promotional review committee (PRC). This position requires an ability to understand and evaluate competing perspectives and provide clear regulatory guidance.
KEY ACCOUNTABILITIES/CORE JOB RESPONSIBILITIES:
Lead the Promotional Review Committee (PRC), Clinical Medical Review Committee (CMRC) and Corporate Communications Review Committee (CCRC) for assigned teams.
Chair review meetings by leading discussion of the material being discussed and collaborating with other reviewers to determine next steps and approval status.
Serves as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription pharmaceutical products. Maintains a thorough understanding of OPDP requirements as well as a keen awareness of enforcement trends.
Works collaboratively with colleagues in the Regulatory Affairs, Medical, Legal, and Commercial organizations. Collaborates cross functionally to provide strategic guidance on promotional considerations for labeling, new product and new indication development activities.
Advises Materials Approval and Review Committees (MARC) Operations Management (MOM) and/or Regulatory Operations group regarding requirements for FDA 2253 submissions.
Serves as primary liaison with FDA’s OPDP reviewers in the request and negotiation of Advisory Comments and any other interactions regarding promotional use of claims for assigned products.
Provide the commercial regulatory perspective and rationale at regulatory project team meetings, brand team meetings and, as needed, providing training to product manager counterparts in marketing and members of the PRC.
Bachelor's degree (or equivalent)
7-10 years of pharmaceutical industry experience, including 3-5 years in regulatory affairs Advertising and Promotionor similar experience
Deep and broad knowledge of FDA regulations and guidelines.
Excellent verbal and written skills. Effectively communicates difficult and complex issues in a way that accurately and persuasively identifies the issues to be resolved to internal and external stakeholders.
Strong interpersonal skills with the ability to influence within a cross-functional team or partnership environment in a positive, effective and professional manner.
Skilled in conflict resolution and negotiation. Fosters open communication. Listens and facilitates discussion and resolution. Able to make ethical and compliant decisions.
Strong organizational and prioritization skills
RAC , PharmD or Lawyer desirable
Experience in commercial regulatory and advertising promotion preferred.
KEY LEADERSHIP COMPETENCIES:
Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
Learns fast, grasps the 'essence' and can change the course quickly where indicated.
Raises the bar and is never satisfied with the status quo.
Creates a learning environment, open to suggestions and experimentation for improvement.
Embraces the ideas of others, nurtures innovation and manages innovation to reality.
Significant Work Activities and Conditions: N/A
Travel: Yes, 10 % of the Time
Job Type: Experienced
Job Level Code: M