Actalent Hiring for Regulatory Affairs Director Advertising And Promotion at New York, New York Full Time

IMMEDIATE Director or Senior Director Regulatory Affairs Ad Promo (Promotional Review) opportunity

with a growing biopharmaceutical company who is committed to delivering innovative and affordable medications to promote patients’ access to advance therapies. They foster a dynamic workplace culture, enormous opportunity for growth and entrepreneurial spirit!

SUMMARY : The Director/Sr. Director of Regulatory Affairs will have accountability for review and approval of all promotional and medical communications of assigned brand(s). They are responsible for leading interactions with the FDA Office of Product and Drug Promotion pertinent to assigned brand(s). The individual will be responsible for all submission types made to OPDP/FDA. This person’s responsibility includes functioning as a leader during review meetings to assure compliance with and evolution of the Promotional Review Committee process enabling business needs to be met efficiently and effectively. Medical communications will be reviewed and approved at MRC in a similar process to PRC.

KEY RESPONSIBILITIES

• Promotional Material Compliance and Strategy: Develop and execute regulatory strategies for the review and approval of promotional materials, including advertising and labeling materials for prescription drug products, to ensure alignment with FDA regulations and guidelines. Provide expert guidance on promotional labeling and advertising requirements, review processes, and potential risks associated with promotional claims.

• Regulatory Submissions and Interactions: Oversee the preparation, review, and submission of promotional materials to the FDA OPDP, ensuring timely and accurate submissions. Act as the primary point of contact for FDA interactions related to promotional materials, including pre-submission meetings, advisory comment requests, and response to regulatory inquiries.

• Cross-functional Collaboration: Collaborate with marketing, medical affairs, legal, and compliance teams to ensure promotional materials are compliant with FDA regulations and company policies

• Regulatory Compliance Oversigh t: Implement a robust monitoring and auditing program to ensure ongoing compliance with FDA regulations for promotional materials.

• Regulatory Intelligence and Advocacy : Stay informed about industry trends, competitor activities, and FDA enforcement actions related to promotional materials, and communicate potential impact to senior management.

• Leadership and Team Management : Lead a team of regulatory affairs professionals, providing guidance, coaching, and mentoring to facilitate their professional growth and success

QUALIFICATIONS

• 10+ years of experience in pharmaceutical regulatory affairs with a focus on FDA promotional material approval, preferably including experience in leading and managing regulatory affairs teams.

• Experience in biosimilars, immunology and oncology is a plus.

• In-depth knowledge of FDA regulations, guidance, and requirements related to promotional materials, including OPDP regulations, 21 CFR Part 202, and other relevant guidelines.

• Strong understanding of pharmaceutical product development and commercialization, including clinical trial protocols, labeling requirements, and product lifecycle management.

• Excellent communication and interpersonal skills, with the ability to effectively interact with internal stakeholders, regulatory authorities, and industry peers.

• Strong leadership and team-building capabilities, with the ability to motivate and develop team members.

EDUCATION

• Bachelor’s degree in pharmaceutical sciences, life sciences, pharmacy, or a related field. A Master’s degree or Ph.D. is a plus.

HYBRID ROLE* 1-2 DAYS PER MONTH ONSITE IS A MUST*

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.