Emcure Pharmaceuticals Hiring Regulatory Affairs Manager / Sr. Manager in Ahmedabad

Emcure Pharmaceuticals Regulatory Affairs Job vacancies

Emcure Pharmaceuticals, a leading name in the pharmaceutical industry, is inviting applications for the position of Regulatory Affairs Manager / Sr. Manager. The position is based in Ahmedabad, Gujarat, and is ideal for candidates with an M.Pharm degree and 15+ years of experience. This is a fantastic opportunity to join a company committed to innovation and excellence in the healthcare sector.

About Emcure Pharmaceuticals

Emcure Pharmaceuticals is renowned for its innovative approach and dedication to improving global healthcare. With a strong presence in various markets, including the US, EU, UK, Canada, and emerging regions, Emcure continues to expand its footprint through cutting-edge research and development. The company’s mission is to deliver affordable and high-quality healthcare solutions to patients worldwide.

Job Details

• Position: Regulatory Affairs Manager / Sr. Manager
• Location: Ahmedabad, Gujarat
• Qualification: M.Pharm
• Experience: 15+ years

Key Responsibilities

• Should have in-depth knowledge of injectables & OSD formulations.
• To manage multiple site Regulatory with multiple dosage forms
• To Develop strategies and ensure to comply with Regulatory Bodies.
• Filing strategy documents for emerging markets and active Involvement in tender Business.
• Hands on Experience in Reviewing, Compilation and Submissions of documents to regulatory agencies. Aware with the changes in various regulatory markets like US/EU/UK/Canada & others like Emerging/ ROW Guidelines w.r.t Regulatory Affairs.
• Cordination with Manufacturing Sites/ R&D/Corporate RA
• Excellent communication and response drafting skills in English Language.

Preferred Candidate Profile

• Educational Background: M.Pharm degree with a strong academic record.
• Experience: Minimum of 15 years of experience in regulatory affairs, particularly in managing injectables and OSD formulations.
• Skills: In-depth knowledge of regulatory requirements, document compilation, and submission processes. Ability to develop regulatory strategies and ensure compliance.
• Soft Skills: Proactive attitude, strong analytical skills, and excellent communication abilities.

Application Process

Interested candidates can apply by sending their resumes to:

• Bhasha Bhatt: bhasha.bhatt@emcure.com
• Mayur Desai: mayur.desai@emcure.com

Office Address: Emcure Pharmaceuticals, Ahmedabad, Gujarat.