Amneal Pharmaceuticals, a leading name in the pharmaceutical industry, is seeking a skilled Regulatory Affairs Labeling Assistant Manager to join their team in Ahmedabad. If you have the required experience and expertise, this could be your next career move. Read on to learn more about this job opportunity.
Amneal Pharma - Regulatory Affairs Labelling Assistant Manager
About Amneal Pharmaceuticals: Amneal Pharma is a renowned pharmaceutical company known for its commitment to quality and innovation. With a strong presence in the industry, Amneal offers a dynamic work environment and opportunities for professional growth.
Job Details:
- Company: Amneal Pharmaceuticals
- Position: Assistant Manager - Regulatory Affairs Labelling
- Experience Required: 6-10 Years
- Location: Ahmedabad, Gujarat
Job Description:
- To review US Labeling documents.
- Compilation and review of US Labeling.
- Review of labeling documents.
- Draft Labeling and Listed Drug Labeling.
- Package Insert Label.
- Handling and submission of labeling Amendments, Supplements and Annual reports.
Key Responsibilities:
- Reviewing and ensuring accuracy of US labeling materials.
- Drafting and compiling labeling documents.
- Managing package insert labeling.
- Handling submissions of labeling amendments and reports.
- Ensuring compliance with regulatory guidelines.
Qualifications and Requirements:
- Bachelor's degree in Pharmacy or related field.
- 6-10 years of experience in Regulatory Affairs Labelling, preferably in the pharmaceutical industry.
- Strong understanding of US labeling regulations and guidelines.
- Excellent communication and organizational skills.
- Attention to detail and ability to work independently.
