Hetero Hiring Regulatory Affairs Assistant Manager (China Market) – Apply Now!
- Hetero Hiring Regulatory Affairs Assistant Manager (China Market) – Apply Now!
- Job Overview
- Key Responsibilities
- Required Skills & Qualifications
- How to Apply?
Hetero Hiring Regulatory Affairs Assistant Manager (China Market) – Apply Now!
Are you an experienced regulatory affairs professional looking for an exciting career opportunity? Hetero, a leading pharmaceutical company, is hiring an Assistant Manager – Regulatory Affairs (API) for the China Market at its Balanagar, Hyderabad facility. If you have 6-10 years of experience in API regulatory affairs and expertise in China Drug Master File (DMF) submissions, this could be your ideal role!
Job Overview
Position: Assistant Manager – Regulatory Affairs (API)
Location: Balanagar, Hyderabad, Telangana, India
Department: Regulatory Affairs
Employment Type: Permanent
Experience Required: 6-10 years
Posted On: March 15, 2025
Key Responsibilities
- Prepare and compile Drug Master Files (DMFs) for China in compliance with regulatory guidelines.
- Conduct thorough reviews of technical and regulatory documentation to ensure accuracy and compliance.
- Prepare and submit responses to deficiency letters (DL) from regulatory authorities.
- Manage the entire regulatory life cycle of API products, including updates, renewals, and variations.
- Work closely with internal teams (R&D, Quality, Manufacturing) and external regulatory agencies to ensure smooth approvals and compliance.
- Maintain up-to-date knowledge of global regulatory requirements and ensure adherence to the latest guidelines
Required Skills & Qualifications
Educational Qualification:
- M.Pharm / B Pharm / MSc. in Chemistry or related scientific disciplines.
Experience Required:
- 6-10 years of experience in Regulatory Affairs (API) with expertise in China DMF compilation, review, and submission.
Key Skills:
- Strong knowledge of global regulatory guidelines, especially China’s regulatory requirements.
- Expertise in DMF preparation, submission, and response handling.
- Excellent analytical and problem-solving skills.
- Effective communication and stakeholder management.
- Ability to identify regulatory challenges and provide strategic solutions.
How to Apply?
Interested candidates can apply online via the official Hetero career portal:
👉 Apply Now
Job Summary Table
| Company Name | Current Vacancies | Required Education | Experience Required | Location |
|---|---|---|---|---|
| Hetero | Regulatory Affairs – Assistant Manager (China Market) | M.Pharm, B Pharm, MSc. Chemistry | 6-10 years | Hyderabad, Telangana |
To apply for this job please visit hetero.darwinbox.in.
