Senior Regulatory Affairs Associate (FDA expertise)

Parexel•Southport, NC

About The Position

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Bring your expert knowledge of FDA regulatory requirements and guidelines to Parexel! We are currently seeking a highly motivated Regulatory Affairs professional to join Parexel and contribute their knowledge of FDA regulatory requirements and processes to a major, dedicated client partnership. As a Senior Regulatory Affairs Associate, you will serve as the primary regulatory liaison with local health authorities (HAs), industry groups, and internal stakeholders. In this role, you will lead regulatory processes, ensure compliance with national legislation, and provide critical support for product launches, integrations, and lifecycle management activities. This is a dynamic position that demands deep regulatory expertise, strong project management capabilities, and the ability to effectively influence cross‑functional teams in a fast‑changing environment.

Requirements

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 is required.
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.

Nice To Haves

Advanced degree (Master’s or PhD) preferred in law, legal affairs, or natural sciences.
Regional Regulatory Affairs Certification (RAC, CARP, CHPC) is a plus.

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.