Alkermes · 2 months ago
Director, Regulatory Affairs, Labeling
Greater Boston
Full-time
Onsite
Director/Executive
$220K/yr - $233K/yr
10+ years expAlkermes is a fully-integrated, global biopharmaceutical company focused on developing medicines for complex psychiatric and neurological disorders. The Director, Regulatory Affairs, Labeling will lead the generation and revision of core labeling documents while collaborating with cross-functional teams and ensuring compliance with regulatory guidelines.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Acts as point of contact for cross-functional teams on local and global labeling issues
Manages labeling development or approval
Preparation of updated Core Data Sheets and US Documentation: Independently manages, prepares and implements regulatory documents (e.g., USPI, annotated labeling, medication guides)
Independently leads cross functional teams through all labeling discussions with the FDA while ensuring management alignment
Strategizes and plans for FDA meetings as needed
Conduct Label Committee Meetings: Prepares documents for review by labeling teams and labeling committee
Leads review processes and ensures appropriate governance for review of labeling documents
Ensure Compliance with Labeling Regulations and Guidance: Researches applicable Health Authority labeling regulations for products and filings
Manages compliance with internal and external guidelines, with regard to both content and format of labeling
Follows internal processes for record keeping and tracking of labeling milestones
Establish Processes and Best Practices: Reinforces labeling best practices at cross-functional meetings
Leads the continuous improvement in process, including enhancement of Standard Operating Procedures (SOPs)
Department Coordination: Builds cross-functional relationships
Leads development of the labeling strategy for multiple products and indications
Oversees and guides the preparation and maintenance of regulatory labeling for multiple products across therapeutic areas
Provides strategic advice and guidance to cross-functional partners and stakeholders
Oversees and guides review/approval of U.S. labeling in Structured Product Labeling (SPL) format, artwork requests, archiving labeling documents, and updating label histories
Develops and maintains target labeling documents for early phase products, in collaboration with GRL and product teams
Maintains an understanding of competitive landscape in assigned disease areas and opportunities for strategic differentiation
Qualification
Required
Bachelor's degree in a health or science-related field and/or an advanced degree
10 or More Years pharmaceutical industry experience
5 or More Years of direct regulatory affairs experience, including US labeling experience required
High level of applied knowledge of applicable FDA laws, regulations, guidance, and industry standards
In depth understanding of clinical trial design and interpretation of clinical data
Strong interpersonal skills, strong communication skills (written and verbal)
Ability to communicate complex issues clearly and concisely
Shape and develop strategies based on emerging trends
Ability to communicate business issues across all levels of the organization, negotiate business decisions, and work toward solutions to drive compliance
Significant experience leading development of regulatory labeling or related strategies, leading cross-functional regulatory activities, and representing Regulatory to cross-functional teams for multiple products
Proven track record in effectively setting and directing the regulatory labeling or related strategy to successful conclusion for one or more products
Significant experience working with a broad array of regulatory labeling documentation and processes, including core data sheets, prescribing information, and target product labels for both marketed and investigational products
Significant experience in NDA/BLA labeling and labeling negotiations
Strong track record of successes working and negotiating with regulatory authorities
Extensive experience participating in cross-functional projects and teams
Benefits
Health Insurance
Great Place to Work in the U.S. in 2024
Healthiest Employer in both Ohio and Massachusetts in 2023
Best Place for Working Parents in 2023
Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023)
Company
Alkermes
Alkermes is a biotechnology company that develops, manufactures and commercializes medicines for the treatment of chronic diseases.
1001-5000 employees
H1B Sponsorship
Alkermes has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (32)
2024 (20)
2023 (21)
2022 (14)
2021 (27)
2020 (22)
Funding
Current Stage
Public CompanyTotal Funding
$250MKey Investors
Primecap Management
2017-11-20Post Ipo Equity
2014-01-13Post Ipo Equity· $250M
2011-09-16IPO
Leadership Team
Craig Hopkinson
EVP, Research and Development, CMO
Recent News
2026-01-24
2026-01-20
Company data provided by crunchbase