About Biocon
Biocon is a global biopharmaceutical company that is committed to delivering innovative and affordable healthcare solutions to patients worldwide. With a focus on research and development, Biocon is at the forefront of advancing global healthcare by developing therapies for chronic diseases such as diabetes, cancer, and autoimmune conditions. The company has a strong regulatory presence in key global markets, including the US and Canada, and prides itself on adhering to regulatory standards and ensuring quality at every step of the product development and manufacturing process.
About the Role
Biocon is seeking an experienced Formulation Regulatory Affairs Associate Manager/Manager for the US/Canada market. The ideal candidate will have 10-16 years of experience and a solid understanding of regulatory guidelines, with expertise in ANDA/ANDS filings. This role will involve preparing, reviewing, and submitting regulatory documentation in the US and Canada markets, as well as collaborating with cross-functional teams on various projects.
Key Responsibilities:
- Preparation, review, and submission of ANDA/ANDS filings for the US and Canada markets, including managing all required modules.
- Provide regulatory inputs during different stages of product development and manufacturing, especially for CMO and CDMO projects.
- Maintain up-to-date knowledge of US regulatory guidelines/requirements and implement necessary changes during product lifecycle management.
- Manage and maintain regulatory databases for all updates received and ensure timely eCTD dossier submissions.
- Review technical documentation (developmental and plant) to ensure compliance with dossier submission requirements.
Required Skills:
- Hands-on expertise in ANDA/ANDS filing for the US market.
- Strong knowledge of US regulatory guidelines and submission processes.
- Previous experience working in a pharmaceutical company with a focus on regulatory submissions.
- Proven ability to manage life cycle management for products filed in the US market.
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Candidate Requirements
- Education: M.Sc. or M. Pharma.
- Experience: 10-16 years in Formulation Regulatory Affairs.
- Strong understanding of the US and Canadian regulatory environments.
- Experience in collaborating with cross-functional teams and providing strategic regulatory inputs.
- Strong time management and organizational skills to ensure timely regulatory submissions.
Application Process
To apply for this role, candidates with relevant experience can share their CVs at rashmi.gupta@biocon.com. Please include the following details in your application:
- Total Experience.
- Current CTC.
- Number of ANDA/ANDS filings completed.
- Notice Period.
- Willingness to work on-site in Bangalore (5 days a week).
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Location
This role is based in Bangalore, India. It is an on-site position, requiring full-time attendance at Biocon’s office. The job involves working closely with Biocon’s teams to ensure that regulatory submissions for the US and Canadian markets are completed in a timely manner.
Benefits of Working at Biocon
At Biocon, employees benefit from being part of an innovative company that is making a real impact on global healthcare. The company offers:
- Exposure to international regulatory markets, including the US and Canada.
- Opportunities to work on cutting-edge pharmaceutical products and processes.
- A collaborative work environment that supports career growth and professional development.
- The opportunity to contribute to a mission-driven organization focused on delivering affordable healthcare solutions.
How to Apply
If you meet the qualifications and are passionate about regulatory affairs, this is your chance to make a significant impact at a leading biopharmaceutical company. Please email your CV to rashmi.gupta@biocon.com with the necessary details.
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This detailed post outlines the Formulation Regulatory Affairs role at Biocon, with a focus on US and Canada market submissions. It includes the responsibilities, qualifications, and the exciting opportunity to work with one of the leading biopharmaceutical companies in India. You can visit the job listing on LinkedIn by clicking here.