Regulatory Affairs Specialist
1 day ago
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Biocon in US/Canada Market. This role is an exciting opportunity for individuals with experience in formulation regulatory affairs.
Key Responsibilities- Prepare, review and submit ANDA/ANDS in the US Market, including modules.
- Contribute to life cycle management for products filed in the US market.
- Maintain comprehensive knowledge of regulatory guidelines and requirements.
- Collaborate with cross-functional teams on product development and manufacturing projects.
- Ensure compliance with US regulatory submissions.
- Manage regulatory databases and publish eCTD dossiers as required.
- Review technical documentation for dossier submission.
- Hands-on experience with ANDA/ANDS filing.
- Experience working in a pharma company.
- Strong understanding of US submissions.
- Proficiency in regulatory guidelines.
This is a full-time position based in Bangalore, India. The ideal candidate will have 7-12 years of experience in a similar role and possess a Master's degree in Pharmacy or Science.
The salary range for this position is approximately ₹20-40 lakhs per annum, depending on qualifications and experience. We offer a competitive package that includes benefits such as medical insurance, retirement plans, and opportunities for professional growth.
Candidates meeting the requirements are encouraged to share their CVs with us. Please mention your total experience, current CTC, number of ANDA/ANDS filings, handling pre-approval activities, and notice period. Additionally, kindly indicate if you are willing to work in Bangalore with a 5-day workweek.
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