Anthea Pharma is dedicated to advancing pharmaceutical manufacturing with a focus on sterile products. Located in the burgeoning industrial area of Pashamylaram, Hyderabad, Anthea Pharma is establishing a state-of-the-art manufacturing facility that adheres to the highest standards of quality and safety. As part of its growth strategy, the company is looking to bolster its team with talented professionals who are committed to excellence and innovation in the field of regulatory affairs.
obligations in the workplace
In order to guarantee that Anthea Pharma’s products adhere to regulatory standards and are compliant with both domestic and international obligations, the Regulatory Affairs – Sr. Executive / Assistant Manager will be essential. Important duties include of:
Regulatory Compliance:
- Manage the life cycle and new product development processes in terms of regulations. Verify that the sterile formulation regulations are being followed.
- Product Development: Oversee the processes involved in developing new products, such as media fills, autoclave certification, dry heat tunnel qualification, and other QA validation tasks.
- Labeling and Documentation: Manage eCTD activities efficiently and make sure that product labeling complies with legal requirements.
- Products that combine drugs and devices: Manage the regulatory issues for goods that combine drugs and devices.
- To address any concerns or inadequacies related to compliance, keep lines of communication open and efficient with internal teams as well as regulatory bodies.
Qualification
The following requirements must be met in order for candidates to be considered for the position:
- Education: Master of Pharmacy, or M.Pharm
- expertise: 8 to 12 years of expertise working with sterile formulations specifically in regulatory issues. It is imperative to possess experience in both new product development and product life cycle management.
Skills
Those that succeed will possess the following abilities:
- Regulatory expertise refers to a thorough understanding of regulatory responsibilities such as manufacturing, sterility assurance, and product development.
- Labeling and Documentation: Expertise in eCTD operations and regulatory labeling standards.
- Proficiency in both written and oral communication is essential for efficiently interacting with internal stakeholders and regulatory agencies.
- Experience: Knowledge of the US and EU markets, as well as experience managing drug-device combo products.
How to Apply
Interested parties are invited to the walk-in interview, which is set for the following time:
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.
