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Director, Regulatory Affairs Ad Promo and Labeling
Job ID: 2
Type: Regular Full-Time
# of Openings: 1
Category: Regulatory Aff – Dept
Radius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative endocrine and other therapeutics. Radius’ lead product, TYMLOS® (abaloparatide) injection, was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture. The Radius clinical pipeline includes investigational abaloparatide injection for potential use in the treatment of men with osteoporosis; an investigational abaloparatide transdermal system for potential use in the treatment of postmenopausal women with osteoporosis; the investigational drug, elacestrant (RAD1901), for potential use in the treatment of hormone-receptor positive breast cancer out-licensed to Menarini Group ; and the investigational drug RAD011, a synthetic cannabidiol oral solution with potential utilization in multiple endocrine and metabolic orphan diseases, initially targeting Prader-Willi syndrome.
Radius is seeking a Director, Regulatory Affairs – Advertising & Promotional Review and Labeling. This role conducts the regulatory review of advertising and promotional materials for assigned products within the Radius Health portfolio and is responsible for development and maintenance of approved labeling in all markets. The incumbent provides regulatory expertise and guidance to Clinical, Pharmacovigilance, Legal, Scientific, Commercial, and other internal stakeholders for successful development of Company Core Data Sheets (CCDSs) and global labeling, i.e., US and EU (CP, MRP, and DCP). The incumbent ensures that there is labeling input in the implementation of regulatory strategies and liaises with regulatory team members in evolving submission and negotiation plans and formulates regulatory labeling strategies for implementation of new and revised prescribing information and packaging . The incumbent reviews advertising, promotional and other related materials for assigned products to ensure compliance with applicable FDA and EU laws, regulations, and guidance . The role can be anywhere on the east coast, with a preference for the Philadelphia area.
- Provides regulatory expertise and guidance for all promotional materials within a collaborative cross-functional team that includes Legal, Medical Affairs, Clinical, and Commercial colleagues.
- Chairs Promotional Review Committee and staff supporting the committee including the PRC coordinator and editor.
- Oversees Scientific Review Committee responsible for review of medical information materials, materials used by Medical Science Liaisons during interactions with HCPs, HEOR materials and other medical presentations.
- Serves as primary contact with the FDA Office of Prescription Drug Promotion (OPDP) for assigned products.
- Reviews and approves Form FDA-2253 submissions to OPDP.
- Works cross-functionally to develop and implement revised/new labeling and supports documentation for assigned products.
- Interprets scientific and clinical data and leads development of labeling to optimize product potential and patient benefit-risk ratio.
- Maintains awareness of regulatory legislation pertaining to both promotion and labeling and assesses and communicates impact on Radius business and products.
- Contributes to Radius Health’s promotional review and labeling policy and standards development and interpretation of regulations.
- Maintains a continued awareness and understanding of global regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products.
- Oversees Labeling Working Team and mentors junior labeling staff.
- Contributes to Radius Health’s labeling policy and standards development and interpretation of regulations.
Experience and Qualifications:
- BA/BS Degree or equivalent, preferably in a health/life sciences or related field.
- Minimum of seven years of experience as a regulatory reviewer of advertising and promotional materials within the pharmaceutical industry.
- Strong knowledge of Global regulations and their interpretation relevant to prescription drug advertising, promotion, and labeling.
- Commercial launch and advisory comment process experience preferred.
- Working knowledge of the drug development process, including labeling development process.
- Understanding of XML and Electronic Document Management Systems to a sufficient level to support labeling documentation.
The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Frequent travel required.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus.
Equal Opportunity Employer Statement:
Radius Health, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Radius Health, Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.
Director, Regulatory Affairs Ad Promo and Labeling – Wayne, Pennsylvania