Are you looking for Regulatory Affairs jobs in Pharma? PAREXEL, a leading global biopharmaceutical service provider, is hiring for Regulatory Affairs Consultant and Senior Regulatory Affairs Associate positions in Bengaluru and Hyderabad. If you have 4-9 years of experience in regulatory submissions for biologics/biosimilars, this could be your next career opportunity!
About PAREXEL
PAREXEL is a renowned name in the pharmaceutical and biotechnology industry, offering contract research, medical communications, and consulting services. They support global drug development, helping bring new treatments to market. With a strong presence in regulated (US, EU, Canada) and emerging markets, PAREXEL is a great place to grow your Regulatory Affairs career.
Job Openings in Regulatory Affairs
1. Regulatory Affairs Consultant
Experience: 7-9 Years
Location: Bengaluru, Hyderabad
Key Responsibilities:
- Author, compile, and submit country-specific regulatory filings (MAA, BLA, post-approval changes) for Biologics/Biosimilars.
- Handle global and regional regulatory submissions with increasing complexity.
- Ensure compliance with FDA, EMA, Health Canada, and other regulatory guidelines.
- Work with Regulatory Information Management Systems (RIMS) like Veeva Vault.
- Manage submission delivery plans and provide updates to stakeholders.
Skills Required:
- Strong knowledge of regulatory frameworks and ICH guidelines.
- Experience in Biologics/Biosimilars regulatory submissions.
- Excellent communication and collaboration skills.
2. Senior Regulatory Affairs Associate
Experience: 4-8 Years
Location: Bengaluru, Hyderabad
Key Responsibilities:
- Prepare and submit regulatory dossiers (MAA, variations, renewals) for global markets.
- Support post-approval regulatory activities and lifecycle management.
- Ensure adherence to regional regulatory requirements (US, EU, Canada, emerging markets).
- Utilize Veeva Vault or other RIM systems for submission tracking.
- Collaborate with cross-functional teams for timely regulatory approvals.
Skills Required:
- Hands-on experience in regulatory submissions for biologics.
- Familiarity with eCTD, CTD formats, and regulatory databases.
- Ability to work independently and in a team environment.
Why Join PAREXEL?
- Work with a global leader in pharmaceutical regulatory services.
- Gain exposure to diverse regulatory markets (US, EU, Canada, emerging regions).
- Career growth in Regulatory Affairs and Drug Development.
- Collaborative work culture with industry experts.
How to Apply?
- Industry Type: Pharma / Healthcare / Clinical Research
- Functional Area: Regulatory Affairs
- Job Location: Bengaluru, Hyderabad
- Last Date to Apply: 30th May 2025
