Associate Director, Commercial Regulatory Affairs

Location
94502, Alameda
Posted
May 01, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Job Description

Responsible for primary regulatory review of promotional materials. Provides regulatory strategic and operational leadership in the areas of advertising and promotion.

Qualifications

ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Provides regulatory guidance for the development, review, implementation, and maintenance of promotional materials and other related activities with minimal oversight. 
• Chairs promotional review committee meetings and effectively collaborates with cross-functional internal groups.
• Responsibility and oversight of promotional material submissions under Form FDA 2253. 
• Manages the development of relevant correspondence with health authorities and interpretation of health authority comments, as well as serving as the primary liaison with relevant personnel in FDA’s Office of Prescription Drug Promotion.
• Maintains current awareness of evolving health authority interpretations; including advisory letters, enforcement letters and policy issues. Communicates significant changes or other relevant matters to internal partners and stakeholders.
• Manage, maintain, and continuously improve processes and systems (including a web-based platform) for review and approval of promotional materials.
• Mentors and provides oversight to junior department members supporting Commercial Regulatory Affairs activities.

SUPERVISORY RESPONSIBILITIES:
• Directly supervise employee(s). 
• Indirectly supervises employee(s) through a dotted line structure or via other subordinate supervisors.

EDUCATION/EXPERIENCE/SKILLS:
Education:

• BS/BA degree in related discipline and ten years of related experience; or,
• MS/MA degree in related discipline and eight years of related experience; or,
• PhD in related discipline and five years of related experience, or;
• Equivalent combination of education and experience.

Experience:
• Minimum of seven years of direct experience in drug advertising and promotion review.
• Relevant working experience with US FDA, including direct experience with OPDP.
•  Experience in oncology drug development and/or commercialization preferred.

Knowledge/Skills/Abilities:
• Robust and demonstrated knowledge of US regulatory requirements for advertising and promotional activities with experience across a variety of complex platforms and media.
• Ability to distill complexity into understandable and actionable language
• Consistently meets deadlines without compromise to work
• Effective cross-functional collaborator and communicator with demonstrated ability to adjust communication style
• Uses expertise and knowledge to contribute to development of company objectives and principles and to achieve goals in creative and effective ways
• Develops technical and/or business solutions to complex problems.
• Exercises problem solving, strategic thinking skills with ability to impact and influence 
• Leads or manage the work of others by providing guidance to subordinates or teams based on organizational goals and company policy.
• Contributes to training of staff, within the department and in other departments.
• Performs a variety of complicated tasks with a wide degree of creativity and latitude with minimal oversight.
• Has good general knowledge of other related disciplines
• Responsible for maintaining a working knowledge of regulatory requirements and guidelines and for communicating changes in regulatory information to departmental and team colleagues
• Applies strong analytical and business communication skills.

JOB COMPLEXITY:
• Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
• Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
• Creates formal networks involving coordination among groups.

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Additional Information

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.