Description:

　　The Head of Regulatory Affairs (RA) will report to the CEO of Celltrion USA and have accountability for review and approval of promotional and medical communications of assigned brand(s). The Head of RA is 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. The applicant’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.

　　This position requires frequent interaction and strong collaboration with Commercial Marketing, Medical Affairs, PRC Coordinators, HQ Legal Affairs, and HQ Regulatory Affairs for the purpose of providing regulatory advice and guidance during promotional plan development all the way through to field implementation assuring conformity with FDA requirements.

　　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.

　　• Provide training and guidance to internal stakeholders on FDA promotional material requirements and best practices.

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

　　• Stay abreast of evolving FDA guidance and regulations related to promotional labeling and advertising and implement necessary changes to maintain compliance.

　　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.

　　• Represent the company in relevant industry forums and participate in advocacy efforts to influence regulatory policies related to promotional materials.

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

　　• Foster a culture of compliance, accountability, and continuous improvement within the regulatory affairs team.

　　EDUCATION

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

　　Experience Level:

　　Expert Level

　　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.