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Parexel · 1 day ago

Senior Regulatory Affairs Associate (FDA expertise)

United States

Full-time

Remote

Mid, Senior Level

3+ years exp

Parexel is seeking a highly motivated Regulatory Affairs professional to join their team and contribute expert knowledge of FDA regulatory requirements. In this role, you will serve as the primary regulatory liaison, leading regulatory processes and ensuring compliance to support product launches and lifecycle management activities.

Pharmaceuticals

H1B Sponsor Likely

Hiring Manager

Lisa B.

Responsibilities

Prepare, organize, and coordinate local documentation (e.g., Module 1) to meet national submission requirements

Maintain and update national systems in line with local legislation (renewals, PSURs, label updates, CMC changes)

Execute timely data entry and validation in Veeva Vault RIMS for submissions and approvals

Review, prepare, and submit dossiers; negotiate with HAs to secure approvals

Provide local input for change control and post-approval requirements

Collaborate with global functions to obtain documentation aligned with local requirements

Support RA representatives during audits/inspections, ensuring readiness and timely CAPA closure

Provide local expertise and responses to inspection queries

Partner with Regulatory, Medical, Marketing, and Market Access teams to assess and mitigate impacts of regulatory changes

Act as the primary RA representative for local Commercial and Medical teams, translating business needs into actionable regulatory strategies

Lead regulatory strategies for product launches and integrations at the affiliate level

Represent the company with local HAs, industry groups, and trade associations, fostering positive relationships

Provide critical support for promotional material review, interpretation of regulations, and implementation of local legislation

Qualification

FDA regulatory expertiseRegulatory submissionsProject managementLife cycle managementRegulatory Affairs CertificationCross-functional collaborationInfluencing stakeholdersLeadership skillsAdaptability

Required

Expert knowledge of FDA regulatory requirements and guidelines

Highly motivated Regulatory Affairs professional

Primary regulatory liaison with local health authorities (HAs), industry groups, and internal stakeholders

Lead regulatory processes and ensure compliance with national legislation

Critical support for product launches, integrations, and lifecycle management activities

Deep regulatory expertise

Strong project management capabilities

Ability to effectively influence cross-functional teams in a fast-changing environment

Prepare, organize, and coordinate local documentation (e.g., Module 1) to meet national submission requirements

Maintain and update national systems in line with local legislation (renewals, PSURs, label updates, CMC changes)

Execute timely data entry and validation in Veeva Vault RIMS for submissions and approvals

Review, prepare, and submit dossiers; negotiate with HAs to secure approvals

Provide local input for change control and post-approval requirements

Collaborate with global functions to obtain documentation aligned with local requirements

Support RA representatives during audits/inspections, ensuring readiness and timely CAPA closure

Provide local expertise and responses to inspection queries

Partner with Regulatory, Medical, Marketing, and Market Access teams to assess and mitigate impacts of regulatory changes

Act as the primary RA representative for local Commercial and Medical teams, translating business needs into actionable regulatory strategies

Lead regulatory strategies for product launches and integrations at the affiliate level

Represent the company with local HAs, industry groups, and trade associations, fostering positive relationships

Provide critical support for promotional material review, interpretation of regulations, and implementation of local legislation

Bachelor's degree in natural sciences (biology, chemistry with pharmacological focus) or equivalent

3–5+ years of local regulatory knowledge and experience in a health authority-facing role

Demonstrated previous life cycle management experience

Comprehensive understanding of regional and global regulatory requirements, guidelines, and processes

Proven expertise in managing regulatory submissions, timelines, and cross-functional teams

Strong project management and leadership skills

Experience influencing Commercial Operations stakeholders and driving business-critical decisions

Demonstrated ability to adapt and succeed in rapidly changing environments

Preferred

Advanced degree (Master's or PhD) preferred in law, legal affairs, or natural sciences

Regional Regulatory Affairs Certification (RAC, CARP, CHPC) is a plus

Company

Parexel

Glassdoor3.9

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster.

Founded in 1983

Raleigh, North Carolina, US

10001+ employees

http://www.parexel.com

H1B Sponsorship

Parexel 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 (33)

2024 (46)

2023 (41)

2022 (51)

2021 (54)

2020 (33)