Join Biocon as a Formulation Regulatory Affairs Specialist - US / Canada Market (On-site)

 

Join Biocon as a Formulation Regulatory Affairs Specialist - US / Canada Market (On-site)

Position Name: Formulation Regulatory Affairs Specialist - US / Canada Market

Organization: Biocon

Qualification: M.Sc. / M. Pharma

Experience: 11 - 16 years

Salary: Not disclosed

Location: On-site (Full-time, Mid-Senior level)

At Biocon, we are committed to delivering high-quality regulatory affairs services. Our team works closely with clients to ensure compliance and accuracy in regulatory submissions. Join us and be a part of a dynamic team that makes a difference in the healthcare industry.

Job Description

THE POSITION:

This position involves various responsibilities in the preparation, review, and submission of ANDA/ANDS in the US market, including modules.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Preparation and Submission of ANDA/ANDS: Hands-on experience in the preparation, review, and submission of ANDA/ANDS in the US market, including modules.
• Life Cycle Management: Experience and knowledge in life cycle management for products filed in the US market.
• Regulatory Guidelines: Comprehensive and up-to-date knowledge of regulatory guidelines and requirements.
• Regulatory Inputs: Provide necessary regulatory inputs to different cross-functional teams (including CMO and CDMO projects) during different stages of product development and manufacturing.
• US Regulatory Submissions: Responsible for understanding the requirements related to US regulatory submissions.
• Regulatory Databases: Maintain necessary regulatory databases concurrently as and when regulatory updates are received.
• eCTD Format: Publish necessary regulatory dossiers into eCTD format as per the country requirement.
• Technical Documentation Review: Review technical (developmental and plant) documentation required for dossier submission.

REQUIRED SKILLS:

• ANDA/ANDS Filing Expertise: Hands-on ANDA/ANDS filing expertise.
• Pharma Experience: A stable candidate from a pharma company.
• US Submissions: Should have experience with US submissions.
• Regulatory Guidelines: Well-versed with regulatory guidelines.

REQUIRED EDUCATION/EXPERIENCE:

• Experience Required: 11 - 16 years
• Qualification: M.Sc. / M. Pharma

Candidates with relevant experience, kindly share CVs to apply at: rashmi.gupta@biocon.com

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