Manager, Regulatory Affairs (Ad-Promo)

Telix Pharmaceuticals (AMER)

14h•Hybrid

About The Position

The Manager, Regulatory Affairs (Ad-Promo), will provide strategic, operational, and tactical regulatory advice to internal stakeholders regarding advertising and promotion materials for investigational products and approved commercial products ensuring they comply with local laws and regulations and company policies, while supporting achievement of business objectives. Manages regulatory review of advertising and promotion materials, disease awareness and training materials, new campaigns, and product launch strategies for all markets. Supports the Senior Director, Regulatory Affairs (Labeling/Ad-Promo), in efforts to influence the regulatory environment.

Requirements

Bachelor's degree in life sciences, law, public policy, or a related field.
Minimum 5 years’ experience in pharmaceutical regulatory affairs, including at least 2 years of experience in regulatory advertising and promotion.
Experience reviewing U.S. advertising and promotion materials and completing Form FDA 2253 for U.S. submissions.
In-depth understanding of relevant international, national, and regional regulatory frameworks, processes, and requirements.

Nice To Haves

A Master's degree or higher is preferred.
Working knowledge of Veeva PromoMats is desired.

Responsibilities

Reviews proposed advertising and promotion materials and disease awareness materials, as assigned, to ensure compliance with applicable laws and regulations and internal policies while supporting commercial objectives.
Supports review of materials for the U.S., Canada, Australia, the UK, Belgium, the Netherlands, Luxembourg, Spain, Germany, and other ex‑U.S. markets.
Participates as the Regulatory Representative on the Materials Review Committee (MRC), collaborating with Medical Affairs, Legal, and Marketing colleagues to assess regulatory risk and provide regulatory input and recommendations on promotional and non‑promotional materials.
Manages regulatory advertising and promotion activities across assigned products.
Manages and coordinates health authority submissions for promotional materials in markets where pre‑clearance or notification is required, ensuring timely and compliant submissions in accordance with local regulatory expectations, including management of Form FDA 2253 for submissions in the U.S.
Applies strong working knowledge of FDA regulations, OPDP guidance, and other requirements governing advertising and promotion of radiopharmaceutical products.
Monitors the evolving U.S. regulatory promotional landscape, including new FDA regulations and guidance, enforcement actions, and industry trends, and communicates key developments to internal stakeholders.
Creates, maintains, and stores abbreviated Prescribing Information (aPI) in accordance with regulatory expectations.
Serves as the regulatory point of contact for global, regional, and local brand teams for assigned products.
Manages regulatory review of ex‑U.S. promotional and non‑promotional materials across priority global markets—including Benelux, Spain, Germany, and the United Kingdom—ensuring accuracy, alignment with local Prescribing Information (PI), and compliance with country‑specific codes, regional and local regulatory expectations, and internal global standards, including timely incorporation of updates following labeling changes.
Supports regional affiliates with interpreting and applying relevant national and regional codes (e.g., EFPIA, ABPI, Farmaindustria, AKG/IFPMA) and helps advise on risk and compliant communication approaches.
Manages coordination with external vendors involved in global review activities, ensuring quality, accuracy, and adherence to timelines.
Maintains efficient global review processes with the vendor by using standardized templates, checklists, and workflows and by escalating issues when needed.
Establishes productive relationships with cross‑functional stakeholders—including Marketing, Medical Affairs, Legal, Clinical, Commercial, Medical Information, and Public Affairs—to enable compliant and effective communication strategies.
Identifies process improvements, best practices, and tools to enhance the efficiency and quality of regulatory advertising and promotion activities.