Unlock Your Career Potential: Join Biocon as a Regulatory Affairs Specialist Now!

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Regulatory Affairs Specialist

Biocon · Bengaluru, Karnataka, India

About the job

We are hiring dynamic individuals in the Regulatory Affairs Department:

Experience: 3 years up to 12 years

Designation: Senior Exec / Assistant Manager / Deputy Manager

Qualification: M. Sc. / M. Pharma / B. Pharma

For below-mentioned roles:

Role 1: API Regulatory Affairs – DMF filing/submission

• Submission to global markets and handling health authority queries.
• Post-approval changes.
• Regulatory input for new molecule development.
• Customer queries and support.

Role 2: Formulation Regulatory Affairs – US/Canada Market ~ Pre-Approval

• Preparation and submission of ANDA filing in the US/Canada Market.
• Deficiency management for products filed in the US/Canada.
• Providing regulatory strategies and inputs.

Role 3: Formulation Regulatory Affairs – US/Europe ~ Post-Approval

• Preparation and timely submission of supplements/variations for global markets.
• Post-approval deficiency response and life cycle management.
• PADER/PSURs and annual reports.
• Hands-on change control assessments.

Role 4: Formulation Regulatory Affairs – Emerging Markets

• Expertise in registration in various emerging markets.
• Capable of handling queries and well-versed in risk mitigation.
• Post-approval life cycle management.

How to Apply

Candidates interested in accelerating their career at Biocon can email their resumes with their current CTC to [email protected] / [email protected] for an interview opportunity within 3-4 days.

Note to Applicants: Only eligible candidates are encouraged to send their CVs in the proper format. We kindly request that you avoid spamming multiple applications, as doing so may result in the permanent blacklisting of your CV at our company. This action could restrict your ability to apply for future vacancies within our organization. We appreciate your cooperation in ensuring a fair and efficient recruitment process. Thank you for your understanding.

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