Senior Regulatory Affairs Associate – CMC Biologics

Parexel

Senior Regulatory Affairs Associate developing regulatory submissions for biological products at Parexel. Collaborating for global and regional regulatory submissions in various markets.

Posted 5/5/2026full-timeRemote • 🇮🇳 IndiaSeniorWebsite

About the role

Key responsibilities & impact

Contribute to preparation and delivery of regulatory submissions from a global and regional perspective
Preparation and review of Marketing Authorization Applications & Variations for filing

Requirements

What you’ll need

5 to 8 years of experience in handling new registration, life cycle management, renewals of Biologicals, Vaccines, recombinant protein molecules, monoclonal antibodies, plasma derived and small molecules in various markets
Good understanding of regulatory framework, including regional trends for various types of applications and procedures for small and large molecules across all regions
Strong communication and collaboration skills
Ability to work independently

Benefits

Comp & perks

Flexible work arrangements
Professional development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory submissionsMarketing Authorization Applicationslife cycle managementrenewalsBiologicalsVaccinesrecombinant protein moleculesmonoclonal antibodiesplasma derivedsmall molecules

Soft Skills

communication skillscollaboration skillsindependence