Senior Regulatory Affairs Associate (FDA expertise) at Parexel

Southport, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

04 Apr, 26

Salary

0.0

Posted On

04 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

FDA Regulatory Requirements, Regulatory Affairs, Project Management, Cross-Functional Collaboration, Regulatory Submissions, Compliance, Audit Support, Strategic Leadership, Documentation, Change Control, Lifecycle Management, Data Entry, Negotiation, Medical Affairs, Market Access, Promotional Material Review

Industry

Pharmaceutical Manufacturing

Description

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. Key Responsibilities: Documentation & Compliance • 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. Regulatory Submissions • 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. Audit & Inspection Support • Support RA representatives during audits/inspections, ensuring readiness and timely CAPA closure. • Provide local expertise and responses to inspection queries. Cross-Functional Collaboration • 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. Strategic Leadership • 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. Education • Bachelor’s degree in natural sciences (biology, chemistry with pharmacological focus) or equivalent. • Advanced degree (Master’s or PhD) preferred in law, legal affairs, or natural sciences. • Regional Regulatory Affairs Certification (RAC, CARP, CHPC) is a plus. Experience • 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. #LI-LB1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40+ years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™

Responsibilities

As a Senior Regulatory Affairs Associate, you will lead regulatory processes and serve as the primary regulatory liaison with local health authorities. You will ensure compliance with national legislation and provide critical support for product launches and lifecycle management activities.