Position Name:
Sr. Executive / Assistant Manager – Regulatory Affairs
Organization:
Anthea Pharma
Qualification:
M.Pharm
Experience:
8 to 12 years
Salary:
Not Disclosed
Location:
Pashamylaram, Hyderabad, Telangana
Job Description:
Anthea Pharma is at the forefront of pharmaceutical manufacturing, with a focus on sterile products. The company is setting up a state-of-the-art manufacturing facility in Pashamylaram, Hyderabad, dedicated to adhering to the highest standards of quality and safety. To support its growth and innovation in regulatory affairs, Anthea Pharma is seeking a Sr. Executive / Assistant Manager.
Job Responsibilities:
| Responsibility | Details |
|---|---|
| Regulatory Compliance | Manage regulatory aspects of product life cycles and new product development, ensuring compliance with sterile formulation standards. |
| Product Development | Oversee processes like media fills, autoclave certification, and QA validation for new products. |
| Labeling & Documentation | Efficiently manage eCTD activities and ensure product labeling meets regulatory requirements. |
| Drug-Device Combo Products | Handle regulatory issues related to products combining drugs and devices. |
| Communication | Maintain effective communication with internal teams and regulatory bodies to address compliance concerns. |
Qualifications:
| Qualification | Requirement |
|---|---|
| Educational | M.Pharm (Master of Pharmacy) |
| Experience | 8 to 12 years in regulatory affairs with a focus on sterile formulations, new product development, and product lifecycle management. |
| Skills | Expertise in regulatory requirements, eCTD activities, and communication with regulatory agencies. |
Skills:
- Regulatory Expertise: Strong understanding of manufacturing, sterility assurance, and product development regulations.
- Labeling & Documentation: Proficiency in eCTD operations and regulatory labeling standards.
- Communication: Effective written and oral communication skills for interaction with internal stakeholders and regulatory bodies.
- Experience: Knowledge of the US and EU markets and handling drug-device combo products.
How to Apply:
Interested candidates are invited to attend the walk-in interview.
- Date: August 24, 2024
- Time: 9:30 a.m. to 1:30 p.m.
- Venue: Anthea Pharma Private Limited, Pashamylaram (v), Patancheru (m), Sangareddy, Telangana – 502307, Plot No.290, Sy.No.219 & 183
Meta Description:
Join Anthea Pharma as Sr. Executive/Assistant Manager in Regulatory Affairs. Walk-in interview on August 24, 2024.
