Amoli Organics Pvt. Ltd has a successful track record in the pharmaceutical and allied industry. Making a beginning as a manufacturer of APIs and Intermediates, it made successful forays in the field of Contract Research and Custom Synthesis. Amoli has been working collaboratively with some of the leading global healthcare players. Presence in USA, EUROPE, JAPAN, RUSSIA, SOUTH EAST ASIA, MIDDLE EAST AND LATAM and it is fast growing and well integrated healthcare group.
Executive / Sr. Executive – Regulatory Affairs @ Amoli Organics Pvt. Ltd.
Roles and Responsibilities:
- Preparation and submission of Regulatory submission for developed APIs/intermediates for various markets.
- Review of regulatory documents.
- Coordinating with concerned department for DMF requirements.
- Preparation of query response and submission towards regulatory agencies.
- Assisting in preparation of updates and revision to maintain the regulatory life cycle of products.
- Change control evaluation and approval of changes with respect to chemistry, manufacturing and control.
- Coordination with marketing department related to customer queries.
- Vendor evaluation as per regulatory requirement.
- Maintaining and updating regulatory database.
Desired Candidate Profile:
- Candidates must have 6+ years of RA experience (API only)
- Confirmed knowledge of ICH guidelines.
- Task oriented with learning attitude and Team work skills.
- Maintain regulatory awareness of current regulations and upcoming changes in the regulatory environment.
Interested candidates can share your CV on amoli.hr@amoliindia.com
Thanks & Regards,
HR Department
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