Regulatory Affairs Specialist
2 days ago
At Biocon, we are seeking an experienced Regulatory Affairs Specialist to join our team and contribute to the development of pharmaceutical products.
Job DescriptionKey Responsibilities:
- We require a skilled professional to prepare, review, and submit ANDA applications for US market approval in a timely manner.
- The selected candidate will be responsible for managing deficiencies and product life cycles filed in the US, ensuring compliance with regulatory requirements.
- Reviewing technical documentation required for dossier submissions is also a key aspect of this role.
- This position involves providing critical regulatory inputs to cross-functional teams, including CMO and CDMO projects, at various stages of product development and manufacturing.
- Publishing regulatory dossiers in eCTD format according to country-specific requirements is essential.
- Maintaining concurrent regulatory databases as updates are received is another crucial responsibility.
- The ideal candidate must have a deep understanding of US regulatory submission requirements.
Qualifications and Experience:
- A minimum of 8 years of experience in regulatory affairs, preferably in the pharmaceutical industry.
- A Master's degree in Pharmacy (M.Pharm) or Bachelor's degree in Pharmacy (B.Pharm) is required.
Estimated Salary Range: $120,000 - $180,000 per annum, depending on location and qualifications. This figure is based on national averages and may vary depending on individual circumstances.
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