Director, Regulatory Affairs Advertising and Promotion

Director, Regulatory Affairs Advertising and Promotion | Recrutus

About Daiichi Sankyo

At Daiichi Sankyo, we are united by a single purpose: to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders.

Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.

About the Role

The Director, Regulatory Affairs Advertising and Promotion (RAAP) serves as a senior strategic and tactical leader for U.S. promotional and selected non-promotional communications across the Daiichi Sankyo portfolio, including alliance assets. Reporting to the Head of RAAP, this role acts as the primary subject matter expert for regulatory advertising and promotion, accountable for guiding compliant and effective communications that align with FDA regulations, enforcement trends, approved labeling, and business objectives.

In this position, you will exercise a high degree of independent judgment to resolve complex, high-risk, and precedent-setting matters with limited oversight. You will serve as a senior advisor to cross-functional stakeholders, playing a pivotal role in labeling forums and supporting the advancement of consistent review practices and scalable processes within the RAAP function. The role requires balancing compliance expectations with business goals while providing clear, risk-based recommendations on claims development, campaign strategy, and scientific messaging.

Hiring Process

Qualified candidates will be considered for this in-office position. The role may require occasional travel. Specific interview steps and timelines will be communicated by the recruiting team upon application review.

Equal Opportunity Statement

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Work location

Work model: On-site

316, Lyons Road, Liberty Corner, Bernards Township, Somerset County, New Jersey, 07920, United States

Bernards Township, New Jersey

Key Responsibilities

check_circleLead regulatory review and decision-making for complex promotional materials and high-visibility initiatives
check_circleProvide strategic regulatory counsel on claims development, campaign strategy, and launch communications
check_circleGuide promotional submissions including Form FDA 2253 and support interactions with regulatory authorities
check_circleInterpret evolving FDA regulations and translate them into actionable regulatory strategy and business guidance
check_circleLead refinement of RAAP SOPs, review standards, and governance practices to improve operational efficiency
check_circleMentor less experienced colleagues and provide training on advertising and promotion requirements
check_circlePartner with cross-functional stakeholders to shape compliant messaging strategies across the product lifecycle

Requirements

verifiedBachelor's degree in scientific, healthcare, or related discipline
verifiedMS, PharmD, PhD, MD, or JD preferred
verified10+ years of relevant pharmaceutical or biotechnology industry experience in Regulatory Affairs
verified7+ years of US regulatory affairs advertising and promotion review experience in oncology
verifiedProduct launch experience required

Nice to Have

MS, PharmD, PhD, MD, or JD degree. 10+ years of relevant pharmaceutical or biotechnology industry experience in Regulatory Affairs, including direct support of U.S. advertising and promotion review.

Skills, education and keywords

Skills: Regulatory Affairs, Advertising And Promotion, Fda Regulations, Form Fda 2253, Subpart E/h, Oncology, Pharmaceutical Industry, Biotechnology Industry, Product Launch, Sop.

Education: Bachelor's degree in scientific, healthcare, or related discipline required; PhD preferred.

Frequently asked questions about Director, Regulatory Affairs Advertising and Promotion at Daiichi Sankyo US

What does a Director, Regulatory Affairs Advertising and Promotion at Daiichi Sankyo US do?expand_more

Day-to-day, the Director, Regulatory Affairs Advertising and Promotion at Daiichi Sankyo US will lead regulatory review and decision-making for complex promotional materials and high-visibility initiatives; provide strategic regulatory counsel on claims development, campaign strategy, and launch communications; guide promotional submissions including form fda 2253 and support interactions with regulatory authorities; and interpret evolving fda regulations and translate them into actionable regulatory strategy and business guidance.

What are the requirements for this Director, Regulatory Affairs Advertising and Promotion role?expand_more

Daiichi Sankyo US is looking for candidates who meet the following requirements: Bachelor's degree in scientific, healthcare, or related discipline; MS, PharmD, PhD, MD, or JD preferred; 10+ years of relevant pharmaceutical or biotechnology industry experience in Regulatory Affairs; 7+ years of US regulatory affairs advertising and promotion review experience in oncology; and Product launch experience required.

Where is the Director, Regulatory Affairs Advertising and Promotion role at Daiichi Sankyo US located?expand_more

Director, Regulatory Affairs Advertising and Promotion at Daiichi Sankyo US is based in 316, Lyons Road, Liberty Corner, Bernards Township, Somerset County, New Jersey, 07920, United States. This is a on-site role.

Is this Director, Regulatory Affairs Advertising and Promotion job remote, hybrid, or on-site?expand_more

Daiichi Sankyo US has listed this Director, Regulatory Affairs Advertising and Promotion role as on-site.

How much experience is required for this Director, Regulatory Affairs Advertising and Promotion role?expand_more

Director, Regulatory Affairs Advertising and Promotion at Daiichi Sankyo US typically requires 10+ years of relevant experience at the executive level.

What skills do you need for the Director, Regulatory Affairs Advertising and Promotion role at Daiichi Sankyo US?expand_more

Key skills for Director, Regulatory Affairs Advertising and Promotion at Daiichi Sankyo US include Regulatory Affairs; Advertising And Promotion; Fda Regulations; Form Fda 2253; Subpart E/h; Oncology; Pharmaceutical Industry; and Biotechnology Industry.

What education is required for Director, Regulatory Affairs Advertising and Promotion at Daiichi Sankyo US?expand_more

Educational requirements for this role: Bachelor's degree in scientific, healthcare, or related discipline required; and PhD preferred.

What category does the Director, Regulatory Affairs Advertising and Promotion role belong to?expand_more

Director, Regulatory Affairs Advertising and Promotion at Daiichi Sankyo US is part of the legal job category on Recrutus.