Sr Director, Regulatory Affairs Advertising, Promotion & Labeling

BioSpace; Cambridge (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

An established industry player is seeking a Senior Director for Regulatory Affairs in Advertising, Promotion, and Labeling. This pivotal role involves providing regulatory expertise, ensuring compliance, and leading cross-functional teams to develop strategic promotional content. With a focus on innovative solutions and high standards, the successful candidate will navigate the complexities of FDA regulations and oversee labeling strategies. This is a unique opportunity to make a significant impact in a forward-thinking organization committed to transforming lives through cutting-edge treatments.

Qualifications

• 10+ years in pharmaceutical/biotech with 8+ years in regulatory review.
• Proven leadership in managing teams and regulatory strategies.

Responsibilities

• Develop compliant strategies for communication and promotional objectives.
• Lead regulatory efforts on the Promotion Review Committee.

Skills

Regulatory Affairs

FDA Regulations

Leadership

Communication Skills

Labeling Strategy

Education

BS degree in a scientific or related field

Advanced degree and Regulatory Affairs Certification

Tools

Regulatory Systems and Software

Job description

Sr Director, Regulatory Affairs Advertising, Promotion & Labeling

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Sr Director, Regulatory Affairs Advertising, Promotion & Labeling

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Why Join Intellia? Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

Why Join Intellia? Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver. We believe in the power of curiosity and pushing boundaries, developing innovative solutions, and maintaining high standards to deliver on our promises to patients.

The Senior Director, Regulatory Affairs Advertising, Promotion & Labeling (Sr. Dir. RA-APL) provides regulatory advertising and promotion expertise, working closely with commercial, medical affairs, research, legal, and executive teams to ensure compliance and strategic alignment of external communications, including promotional content. The role also leads labeling strategy and cross-functional labeling teams.

Responsibilities include:

• Serving as a subject matter expert for Regulatory Affairs Ad/Promo, developing compliant strategies to support communication and promotional objectives.
• Leading regulatory efforts on the Promotion Review Committee (PRC) and serving as the lead Regulatory Advertising & Promotion expert on the Medical Review Committee (MRC).
• Assessing risks surrounding promotional claims and campaigns, and evaluating the impact across organizational segments.
• Overseeing labeling development and providing strategic guidance on labeling regulations, trends, and competitor activities.

Additional duties:

• Reviewing and approving external promotional and scientific materials.
• Supporting commercial teams with regulatory guidance on marketing strategies.
• Developing guidelines for external communication content.
• Maintaining awareness of evolving FDA regulations and communicating changes.
• Managing labeling content, including Target Product Labels (TPL) and Core Data Sheets (CDS).

Supervisory responsibilities:

Recruits, trains, and evaluates staff, oversees workflow, and manages external consultants.

Minimum requirements:

• BS degree in a scientific or related field; advanced degree and Regulatory Affairs Certification preferred.
• 10+ years of pharmaceutical/biotech experience, with at least 8 years in regulatory review of promotional materials.
• Proven leadership in managing teams and regulatory strategies, with strong knowledge of FDA and global labeling regulations.

Additional info:

Requires knowledge of pharmaceutical labeling, excellent communication skills, and proficiency with regulatory systems and software.

EEOC and COVID-19 vaccination policies apply.