Amneal Pharmaceuticals, a leading name in the pharmaceutical industry, is seeking experienced Regulatory Affairs professionals for Injectable roles in Ahmedabad. If you have expertise in regulatory strategies for complex products and are looking for a rewarding career opportunity, read on to discover more about these positions at Amneal.
Amneal Pharmaceuticals: Career Opportunities in Regulatory Affairs - Injectable
About Amneal Pharmaceuticals: Amneal Pharmaceuticals is a renowned pharmaceutical company committed to delivering high-quality healthcare solutions. With a focus on innovation and excellence, Amneal provides a dynamic and collaborative work environment for professionals in the pharmaceutical industry.
Job Details:
- Company: Amneal Pharmaceuticals
- Position: Regulatory Affairs - Injectable (Executive/Senior Executive/Asst. Manager/Deputy Manager)
- Experience Required: 4-12 Years
- Location: Ahmedabad, Gujarat
Job Description: As a Regulatory Affairs - Injectable professional at Amneal Pharmaceuticals, you will play a crucial role in developing and finalizing regulatory strategies for complex products, specifically injectables, for the US and EU markets. Your responsibilities will include preparing regulatory submissions, drafting meeting packages, reviewing controlled correspondences, and ensuring compliance with regulatory requirements.
Key Responsibilities:
- Develop and finalize regulatory strategies for complex products, including injectables, peptides, microspheres, liposomes, etc., for the US and EU markets.
- Prepare and review regulatory submissions such as Pre-ANDA/Pre-IND/ScA meeting packages.
- Draft and finalize controlled correspondences on complex regulatory issues.
- Review and finalize deficiency responses for complex products.
- Collaborate with cross-functional teams and provide training on new regulatory requirements.
- Ensure timely and quality delivery of regulatory documents and responses.
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Qualifications and Requirements:
- Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, or related field.
- 4-12 years of experience in Regulatory Affairs, specifically in injectables and complex products.
- Strong knowledge of US and EU regulatory requirements and processes.
- Experience with regulatory submissions, deficiency responses, and controlled correspondences.
- Excellent communication, collaboration, and leadership skills.
- Ability to work in a fast-paced and dynamic environment.
How to Apply: If you meet the qualifications and are interested in these positions, please send your CV to kavitriy@amneal.com with the subject line "Application for Regulatory Affairs - Injectable." Note that freshers and candidates from other departments are not eligible for these roles. https://pharmastuff.org.in/job/amneal-pharma-regulatory-affairs-injectable?feed_id=9467
