Associate Director, Regulatory Labeling
Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role.
Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company’s approach at ScholarRock.com and follow @ScholarRock and on LinkedIn.
Summary of Position:
The Associate Director, Regulatory Labeling is a regulatory labeling leader with expert technical and operational experience in regulatory labeling, globally, and is responsible for overseeing the development, implementation and maintenance of global product labeling content and strategy for products across various stages of drug development. This role will also be responsible for generating Scholar Rock labeling process, coordinating creation of the initial Company Core Data Sheet (CCDS), Prescribing Information (PI) and Patient Information Leaflet (PIL) in select markets (typically US and EU). This position will also coordinate and run the Labeling Working Group (LWG) and ensure compliance with labeling regulations and guidance.
Position Responsibilities:
- Holds primary responsibility for development of product labeling, including core labels and local US and EU labeling,
- Conduct research related to labeling precedent, regional regulatory policies, and other topics, as necessary, to advise on potential labeling impact, strategy, or outcome.
- Lead the Label Working Group (LWG) for assigned programs/products to drive alignment of labeling content and strategy and represent the regulatory labeling function at governance meetings.
- Provide input into strategy for Health Authority interactions regarding all aspects of labeling, including submissions, responses to questions, and negotiations.
- Accountable for compliance with health authority requirements, labeling governance requirements and associated business processes.
- Leads the continuous improvement of labeling processes to enhance efficiency. Provides department/company training on labeling practices and policies.
- Provide assistance to the Regulatory Affairs Advertising and Promotion function to support the commercialization of marketed products.
Candidate Requirements:
- Bachelor’s degree or advanced scientific degree (MSc, PhD, PharmD) preferred
- 5+ years of direct experience in regulatory affairs global labeling
- Experience that demonstrates ability to create development labeling processes and documents (initial CCDS).
- Ability to research and understand complex scientific and regulatory information and distil important aspects for impact to labeling.
- Strong project management skills to plan, prioritize, lead, and execute individual work, and teamwork related to regulatory labeling in a systematic and efficient manner.
- In-depth and practical knowledge of labeling requirements globally (USPI and SmPC required), including development and life-cycle management of local PIs and PILs.
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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