Senior Executive, Regulatory Affairs at Amneal, Ahmedabad
An Amneal regulatory affairs job has emerged for experienced professionals in Ahmedabad. The organization seeks a Senior Executive with 5-8 years of experience to oversee the preparation and submission of regulatory applications for inhalation products. Interested candidates are encouraged to explore this opportunity.
About The Company
Amneal Pharmaceuticals is a global pharmaceutical company dedicated to providing high-quality generic and specialty medications. With a commitment to innovation and patient care, Amneal operates in various therapeutic areas and is known for its robust research and development capabilities. The company is headquartered in the United States and has a significant presence in the pharmaceutical sector.
Amneal Regulatory Affairs Job Details
- Position: Senior Executive, Regulatory Affairs
- Location: Ahmedabad
- Experience Required: 5-8 years
Job Description
In this Amneal regulatory affairs job, the Senior Executive will be responsible for compiling, preparing, reviewing, and submitting high-quality US ANDA and EU marketing authorization applications for MDI/DPI inhalation products. This role involves ensuring compliance with regulatory requirements and internal procedures while maintaining established timelines.
Key Responsibilities
- Compile, prepare, review, and submit high-quality US ANDA and EU marketing authorization applications.
- Perform comprehensive regulatory evaluations of assigned drug products.
- Prepare Controlled Correspondence submissions and pre-ANDA meeting packages.
- Conduct regulatory assessments of various CMC documentation.
- Actively participate in cross-functional team meetings and discussions.
- Ensure compliance with US FDA ANDA Checklist and EU regulatory requirements.
- Develop and implement regulatory strategies for MDI/DPI inhalation products.
- Maintain oversight of all regulatory activities for assigned projects.
Eligibility Criteria
- 5-8 years of experience in Regulatory Affairs.
- Experience with US ANDA and EU marketing authorization applications.
- Strong understanding of regulatory compliance and documentation.
Required Skills
- Excellent communication and interpersonal skills.
- Strong analytical and problem-solving abilities.
- Attention to detail and ability to manage multiple projects.
- Experience in cross-functional collaboration.
Interested candidates can apply online through the following link:
CLICK HERE FOR THE ORIGINAL NOTIFICATION / APPLY ONLINE
This Amneal regulatory affairs job presents an exciting opportunity for qualified candidates to contribute to the regulatory affairs of inhalation products. Interested individuals are encouraged to apply before the deadline to ensure their consideration for this role.
