Openings in Regulatory Affairs at PAREXEL - Consultant and Associate post

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

Job Description
• 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.

Candidate Profile
Regulatory Affairs Consultant
• 7-9 yrs of experience of authoring, compiling and submission of country-specific submission files (MAA, and post-approval changes) of Biologic 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. Working experience 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.

Senior Regulatory Affairs Associate
• 4 to 8 years of experience of authoring, compiling and submission of country-specific submission files (MAA, and post-approval changes) of Biologic 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. Working experience 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.

Additional Information
Experience : 4 to 9 Years
Location : Bengaluru, Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th May 2025