Regulatory Affairs Jobs at PAREXEL

PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries.

Post : Regulatory Affairs Consultant, Senior Regulatory Affairs Associate

Key competencies
• Experience and expertise in authoring, compiling and submission of country specific submissions (MAA,BLA, and post approval changes) of Biologics/Biosimilar products in various markets- Regulated (EU/US/Canada) and emerging markets.
• Contribute to preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.
• Good understanding of regulatory guidelines, regulatory framework, including regional trends, for various types of applications and procedures.
• Proficiency in Regulatory Information Management Systems like Veeva Vault.
• Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
• Strong communications and collaboration skills; ability to work independently.

Regulatory Affairs Consultant
• Around 7-10 years of relevant experience in handling life cycle management (LCM) of approved/marketed drug products (Biologicals, Vaccines, ) in various markets, mainly in US, EU, Japan, Canada Switzerland, Australia.
• Good understanding of regulatory framework, including regional trends, for various types of applications and procedures.
• Lead and / or contribute to the planning, preparation, authoring and delivery of regulatory maintenance submissions from either a global and/or regional perspective.
• Working knowledge of US, EU, Japan, Canada, Switzerland, Australia regulatory procedures including post approval requirements. Knowledge of ROW markets regulatory legislations would be an added advantage
• Experience in handling CMC related health authority queries, and author responses to HA requests
• Preparation / Review of Regulatory gap analysis and strategy documents (with remediation plans for identified gaps) for submissions like IND, IMPD, DMF, BLA, NDA, and MAA applications.
• Authoring and review of CMC component of Marketing Authorization Applications & Variations for various types of medicinal products (orals & parenteral) for filing in EU through different types of procedures (DCP/MRP/National Procedures).
• Authoring CMC component for marketed products, of Annual Reports, Variations, expansions, site transfers, Renewals in EU (Type IA/IB/II/IAIN), and US, Canada, Switzerland and RoW markets.
• Evaluation of change controls and deviations and identification of required documentation and strategy for US, EU, Japan, Canada, Switzerland, Australia submissions and other markets.
• Co-ordination with internal and external stakeholders for documentation required for various submissions. Identify quality and/or timeliness issues with source documents, as early as possible.
• Develop up-to-date knowledge about regulatory guideline updates and applying regulatory requirements and their impact on submissions.
• Working experience in Regulatory Information Management Systems (RIMS) like Veeva Vault.
• Strong communications skills and ability to guide and mentor team members.
• Ability to work independently.

Senior Regulatory Affairs Associate
• 5 to 8 years of experience in handling of new registration, life cycle management, renewals of Biologicals, Vaccines, recombinant protein molecules, monoclonal antibodies, plasma derived and small molecules in various markets, mainly in US, EU, Japan, Canada Switzerland, Australia.
• Contribute to preparation (including authoring where relevant) and delivery of regulatory submissions from a global and regional perspective.
• Preparation and review of Marketing Authorization Applications & Variations for filing in US, EU, Japan, Canada Switzerland, Australia.
• Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries.
• Strong communication and collaboration skills, ability to work independently.

Additional Information
Experience : 4 to 9 Years
Location : Bengaluru, Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 20th April 2026