Senior Director, Regulatory Affairs Advertising & Promotion (Boston)

Vertex Pharmaceuticals Incorporated; Boston (MA); Remote; USD 140,000 - 200,000; Full time

Job summary

A leading biotechnology company seeks a Senior Director of Global Regulatory Affairs Advertising Promotion. This role is pivotal in managing promotional communications for Vertex products, ensuring regulatory compliance while leading a team of reviewers. Candidates should possess strong regulatory expertise, communication skills, and a minimum of 12 years in the pharmaceutical industry, ideally with supervisory experience. The position offers flexibility in work arrangements and comprehensive benefits.

Benefits

Healthcare

Paid time off

Educational assistance

Diversity and equal employment opportunity

Qualifications

• Typically requires 12 years of experience, including 5 years in supervisory roles.
• Expertise in health authority regulations and promotional communications.
• Extensive pharmaceutical industry experience.

Responsibilities

• Lead regulatory reviews for promotional communications and ensure compliance.
• Collaborate with Medical, Legal, and Commercial teams for effective strategies.
• Manage and develop team members with oversight of regulatory reviews.

Skills

Decision-making

Problem-solving

Risk management

Communication

Project management

Presentation

Education

Bachelor's degree in a relevant scientific discipline

Job description

The Senior Director, Global Regulatory Affairs Advertising Promotion is responsible for providing commercial regulatory strategy and oversight in the development, review, and approval of product, pipeline, and disease state promotional and non-promotional communications for Vertex products and development programs. This role involves collaboration with stakeholders including Commercial, Medical Affairs, and Corporate Communications.

This leadership position directly leads a team of regulatory reviewers on Communication Review Committees and Medical Review Committees (MRCs). Reporting to the VP, Global Regulatory Affairs, Advertising and Promotion, the role provides strategic direction for systems, processes, and cross-functional teams to ensure compliant and effective communications that meet business objectives.

Key responsibilities include:

1. Providing US/global oversight to Communications Review Committee (CRC) and Medical Review Committee (MRC) teams for product promotion, non-promotional, and related communications.
2. Ensuring ongoing compliance with regulatory requirements while aligning with corporate and business strategies.
3. Collaborating with Medical, Legal, and Commercial teams to integrate regulatory requirements into communications.
4. Overseeing regulatory reviewers in assessing regulatory context and providing interpretations of guidance, regulations, or precedents.
5. Ensuring that product labeling changes are accurately reflected in promotional materials.
6. Monitoring advertising and promotion regulations and guidelines to support compliant marketing.
7. Managing and developing team members, with potential financial and HR responsibilities.

Qualifications include:

• Expertise in applicable health authority codes, laws, regulations, and industry standards related to advertising and promotional communications about prescription drugs, devices, and investigational treatments.
• Deep understanding of clinical study design and statistical analyses related to promotional claims.
• Strong decision-making, problem-solving, and risk management skills.
• Ability to influence cross-functional teams and senior management effectively.
• Excellent communication, project management, and presentation skills.
• Extensive pharmaceutical industry and regulatory advertising/promotional experience, including supervisory roles and interactions with health authorities.
• Bachelor's degree in a relevant scientific discipline.
• Typically requires 12 years of experience and 5 years in supervisory/management roles, or equivalent education and experience.

This role is remote-eligible, with flexible work arrangements subject to company policy. Vertex offers comprehensive benefits, including healthcare, paid time off, educational assistance, and more. Vertex is committed to diversity and equal employment opportunity, providing accommodations as needed for applicants with disabilities.