Director, Commercial Regulatory Affairs

DIRECTOR, COMMERCIAL REGULATORY AFFAIRS

Position Summary:

This position is responsible for the commercial regulatory requirements of company product(s). Responsibilities include establishment of review policies, review of commercial materials (promotional and training materials), and management of the preparation of regulatory filings. Responsible for developing strategies/timelines, conducting meetings, and acting as liaison with the Food and Drug Administration's Office of Prescription Drug Promotion (OPDP). Works closely with other functional areas such as Marketing, Legal, Sales Operations, and Medical Affairs.

Essential Duties and Responsibilities:

• Develop, execute, and provide guidance for effective, proactive commercial regulatory strategies and plans.
• Manage the regulatory aspects of promotional materials (press releases, website, social medial review, etc.), as well as sales training materials.
• Support post-marketing activities for commercial products, including review and approval of commercial labeling and advertising/promotional materials, based on domestic and international regulatory requirements.
• Provide interpretive analyses of complex regulatory guidance documents, regulations, or directives that impact the Company's promotion of products and operations. Advise personnel in other departments regarding their applicability and impact.
• Perform regulatory intelligence activities to keep current on the OPDP environment and competitive products; communicate such environment to the teams.
• Interface with other team leaders to ensure coordination and implementation of consistent standards and processes.
• Proofread documents and work closely with Regulatory Operations to publish the final regulatory OPDP submission.
• Interact with key personnel in OPDP.
• Update and provide appropriate promotional compliance and regulatory training and education to contracted staff e.g. contracted physicians, speaking on behalf of company.
• Provide appropriate promotional compliance and regulatory training and guidance to sales reps and medical science liaisons regarding their respective roles and responsibilities.

Qualifications:

• 10 years of experience in pharmaceutical industry or equivalent, with a minimum of 5 years in Regulatory Affairs.
• Bachelor's degree; advanced degree preferred.
• Experience and a thorough understanding of the preparation of promotional material and the translation of regulatory requirements into practical plans.
• Excellent and effective written and oral communication skills, including presentation skills and interpersonal skills.
• Must be able to interpret and apply government regulations.
• Exceptional cross-functional team leadership skills.
• Ability to work in close collaboration with others.
• Strong organizational and planning skills, as well as strong attention to detail
• Accountable for results and goal attainment.
• Experience with electronic submissions requirements and the review of promotional materials prepared in support of regulatory filings.
• Ability to work independently with limited supervision, adapt to change and manage multiple tasks.
• Ability to problem-solve and make decisions on complex issues, often in a cross-functional team setting.
• Technical knowledge of US regulations and ICH and GXP Guidelines.
• Strong computer skills in Word, Access and Adobe Acrobat and working knowledge of electronic publishing/file management.

Fit with GBT culture:

• Ability to build strong relationships with co-workers of various backgrounds and expertise
• Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
• Values-based leadership consistent with GBT's Core Values
• Excitement about the vision and mission of GBT
• Flexibility
• Integrity

NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.