Senior Manager - Regulatory Affairs - Pharma

Department: Regulatory Affairs

Location: Gujrat

Reports To: Director of Regulatory Affairs

The Senior Regulatory Affairs Manager is responsible for ensuring the regulatory compliance of pharmaceutical products across various markets. This includes managing regulatory submissions, interacting with regulatory agencies, and ensuring that the company's products meet all necessary legal requirements for approval and distribution.

Key Responsibilities:

- Prepare and manage regulatory filings (NDA, ANDA, BLA).

- Liaise with regulatory bodies (FDA, EMA, etc.) to ensure timely approvals.

- Monitor and ensure compliance with global regulatory standards.

- Collaborate with cross-functional teams (R&D, manufacturing, commercial) to align on regulatory strategy.

- Stay updated on regulatory changes and advise the business on their impact.

Skills and Qualifications:

- Bachelor's or Master's degree in Pharmacy, Life Sciences, or related field.

- 10 + years of experience in Regulatory Affairs in the pharmaceutical industry.

- Strong knowledge of global regulatory guidelines.

- Excellent communication and organizational skills.