Senior Manager, Regulatory Affairs

Vericel® Corporation

. Independently plan, prioritize, and manage regulatory activities across assigned development and commercial products .

Posted 10/3/2026full-timeBurlington • Massachusetts • United StatesSenior💰 $188,000 - $205,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive expertise in Regulatory Affairs with a focus on biologics, including the development and submission of INDs and BLAs. Proven ability to lead complex regulatory projects, navigate FDA regulations, and communicate effectively with cross-functional teams and regulatory authorities.

Highest-signal resume keywords

Regulatory Affairs ExperienceBiologics Submission ManagementFDA Regulations KnowledgeRegulatory Writing SkillsCross-Functional Project Leadership

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Regulatory Strategy DevelopmentIND SubmissionBLA SubmissionECTD KnowledgeRegulatory ComplianceLabeling RegulationsPrescription Drug Advertising RegulationsRegulatory Risk AssessmentSOP DevelopmentRegulatory Dossier Preparation

Soft Skills

Communication SkillsNegotiation SkillsAttention to DetailAbility to Manage Competing PrioritiesTeam Collaboration

Industry Keywords

BiotechnologyPharmaceutical IndustryRegulatory AuthoritiesHealth Authority RequestsCross-Functional TeamsCROsExternal VendorsScientific DisciplineAdvanced DegreeRegulatory Best Practices

Tech Stack

Tools & technologies

Assembly

About the role

Key responsibilities & impact

Independently plan, prioritize, and manage regulatory activities across assigned development and commercial products
Develop and implement regulatory strategies supporting timely approvals, continued compliance, and company objectives
Manage assembly and timely submission of INDs, BLAs, and other dossiers for biologics investigation and registration
Assess priorities, identify regulatory risks and opportunities, make recommendations, and escalate significant issues with proposed solutions or mitigation plans
Respond to changing regulatory requirements, health authority requests, emerging product issues, and shifting business priorities
Maintain regulatory submissions in compliance with regulatory requirements
Represent the company in dealings with the FDA and other regulatory authorities
Serve as regulatory lead or subject-matter expert on cross-functional project teams
Provide guidance across products, regulatory pathways, biologics, and combination products
Maintain current regulatory knowledge and advise management of significant developments
Contribute to improvements involving best practices and SOPs
Interface with departments, CROs, and external vendors as needed
Reports to the Director, Regulatory Affairs

Requirements

What you’ll need

8+ years of progressive Regulatory Affairs experience in the biotechnology or pharmaceutical industry
Substantial experience supporting biologics
Experience independently leading complex regulatory projects and developing regulatory strategy
Experience driving cross-functional submissions through completion with limited oversight
Experience and knowledge preparing BLA submissions and supportive amendments and supplements
Experience with prescription drug advertising regulations and promotional review committees
Experience with labeling regulations
Working knowledge of FDA regulations and FDA structure and function
Working knowledge of eCTD elements and structure
Strong regulatory writing and verbal communication skills
Ability to communicate, negotiate, and influence regulatory strategy with cross-functional partners, senior leadership, external partners, and health authorities
Attention to detail; ability to operate independently, act with urgency, manage competing priorities, and work within multidisciplinary teams and with external partners and vendors
Bachelor of Science in a scientific discipline
Advanced degree preferred
Occasional travel (5-10%)

Benefits

Comp & perks

Ability to work remotely on Fridays
Mission-driven work helping bring cell therapies to patients
Career growth opportunities
Collaborative, supportive cross-functional team culture
Bonus, incentive pay, equity and benefits may be provided in addition to base compensation
Occasional travel (5-10%)