Regulatory Affairs Specialist
5 days ago
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Cipla. As a key member of our India Regulatory Affairs function, you will be responsible for ensuring compliance with regulatory requirements and facilitating timely product approvals.
Your primary focus will be on coordinating with internal stakeholders to prepare regulatory submission dossiers as per DCGI requirements. You will also prioritize projects, follow up with stakeholders for early submission and approval, and ensure approvals for drug launches and Fixed Dose Combination (FDC) products.
Additionally, you will collaborate with internal stakeholders to streamline processes, meet approval timelines, and drive full compliance with regulatory requirements for India. Your expertise in analyzing market intelligence data and preparing regulatory monitors will be essential in capturing key regulatory developments on a monthly basis.
You will engage with external stakeholders, including the DCGI office, ICMR, DBT, NPPA, and DoP, to strengthen advocacy and ensure positive relations with regulators and government officials.
In this role, you will also coordinate with internal teams on pricing-related notices and approvals for new launch products, ensuring timely NPPA submissions and advocacy with NPPA officials.
Key Responsibilities:
- Coordinate with internal stakeholders for regulatory dossier preparation and submission
- Prioritize projects and ensure timely submissions and approvals
- Engage with external stakeholders to advocate for company interests
- Coordinate with internal teams on pricing-related notices and approvals
Requirements:
- B. Pharm/M.Pharm/PhD degree
- 12-15 years of experience in India Regulatory Affairs
- Excellent communication and interpersonal skills
- Ability to analyze complex information and make informed decisions
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