Sun Pharma, a leading global pharmaceutical company, is looking for experienced professionals to join their Regulatory Affairs team as Executive or Senior Executive. This role requires 3-5 years of experience in Regulatory Affairs CMC for the US and EU markets. The positions are available in Gurgaon and Vadodara. If you hold an M. Pharma degree and have the required experience, this could be a great opportunity for you.
About Sun Pharma: Sun Pharma is one of the largest specialty generic pharmaceutical companies in the world, providing high-quality, affordable medicines trusted by healthcare professionals and patients in over 150 countries. Our commitment to research and innovation drives us to develop products that improve quality of life and meet the highest regulatory standards.
Job Location and Qualifications:
- Locations: Gurgaon and Vadodara
- Required Qualification: M. Pharma
- Required Experience: 3-5 years in Regulatory Affairs CMC, specifically for the US and EU markets
Key Responsibilities: The Regulatory Affairs Executive/Senior Executive will be responsible for managing regulatory activities related to Chemistry, Manufacturing, and Controls (CMC) for New Drug Applications globally. This includes:
- Supporting and managing filing activities, query responses, and post-approval changes.
- Ensuring regulatory strategies align with Health Authority requirements globally.
- Understanding and sharing global regulatory requirements, particularly for the US, EU, Japan, China, and other markets.
- Working closely with consultants, partners, and local regulatory colleagues to understand regional requirements.
- Preparing agency consultation packages, briefing books, and required presentations, and engaging with agencies for consultations.
- Providing CMC support for other branded projects as needed.
- Coordinating with global manufacturing sites and integrating regulatory strategy with those sites.
- Preparing IND and IMPD documents.
- Providing consistent support to commercial and clinical teams.
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Sun Pharmaceutical Industries recruitment notification[/caption]
Ideal Candidate Profile: The ideal candidate should have:
- A strong understanding of global regulatory requirements, particularly for the US and EU markets.
- Excellent communication skills to work effectively with cross-functional teams, consultants, and regulatory authorities.
- The ability to prepare high-quality regulatory submissions and respond to queries promptly.
- Strong project management skills to ensure timely completion of regulatory activities..
6. Application Process: If you meet the qualifications and are interested in this exciting opportunity, please send your resume to
ShikhaKumari1.HR@sunpharma.com. Ensure that your application highlights your relevant experience and qualifications.
https://pharmastuff.org.in/job/sun-pharma-hiring-regulatory-affairs-executive-senior-executive
