Alkermes · 2 months ago
Associate Director, Regulatory Affairs Operations
Greater Boston
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$153K/yr - $171K/yr
10+ years expAlkermes is a fully-integrated, global biopharmaceutical company committed to developing medicines for complex psychiatric and neurological disorders. The Associate Director, Regulatory Operations will manage regulatory submissions and oversee regulatory systems while collaborating with cross-functional teams to ensure submission readiness and operational excellence.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Lead end-to-end management of regulatory submissions, ensuring timely, compliant, and high-quality deliverables
This role interfaces with external publishing vendor(s) for the preparation of submissions, and internal stakeholders to provide operational oversight and support for eCTD regulatory submission activities
Serve as submission manager and primary contact for publishing vendors and internal stakeholders
Oversee regulatory document management, tracking, and archival activities
Manage regulatory systems (e.g., Veeva RIM, PromoMats), and serve as internal subject matter expert (SME) for training and support to internal stakeholders
Develop and implement processes, templates, and tools that improve submission efficiency and consistency
Partnering with IT to maintain the regulatory technology landscape including maintenance, updates, and releases
Provide subject matter expertise on regulatory technologies and submission best practices
Monitor new regulations and industry trends to assess impact on operational practices
Qualification
Required
Bachelor's degree in a scientific or related field
At least 10 years of related experience, with at least 8 years of regulatory operations experience in the biotech or pharmaceutical industry
Preferred
Strong understanding of eCTD submission standards and regulatory requirements across global regions
Proven experience with IND/CTA and NDA/MAA submissions, including lifecycle management
Hands-on experience with Veeva RIM and/or PromoMats strongly preferred
Experience managing outsourced publishing vendors a plus
Skilled at balancing strategic oversight with hands-on execution
Strong communicator and collaborator with excellent organizational skills
Benefits
Annual performance pay bonus
Competitive benefits package
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
2026-01-06
Company data provided by crunchbase