Hetero Labs Walk In Interview 2023/Hetero Labs Notification full details below. Interested and eligible candidates can attend Interview on scheduled time and venue.HETERO LABS LIMITED is one of the Indias leading generic pharmaceutical companies and is one of the worlds largest producer of anti-retroviral drugs for the treatment of HIV/AIDS.
Vacancy details:
- Designation: REGULATORY AFFAIRS-CMC-DP
- Qualification: Any Graduate
- Experienced: 3 – 8 Years
- Salary: ₹ 50,000 – 3,00,000 P.A.
Job Description: Greeting from Hetero Labs !!!!!!!
Important Details :
- Location: Jadcherla
- Post of date:23/01/2023
- Selection Process: The selection will be on the basis of Interview.
Roles and Responsibilities
We are hiring candidates for the position of Regulatory Affairs -CMC-DP Manufacturing
Work location: Jadcherla,Telangana State.
Key skills: Aspetic Filling ,Packaging, Sterile Operations, DP Manufacturing, RA, Biologics ,Biosimilars
Role & Responsibilities :
To compile dossier for Biosimilar products in CTD/ACTD/ Country Specific format
and its submission as per regulatory requirement of particular country in Asia
Pacific, Africa and South Africa markets.
To study and update regulatory guideline of assigned countries and to prepare
checklist/ template for registration dossier.
To evaluate queries raised by regulatory authority/customer and prepare response.
Communication, Coordination and Collaborate with different internal
stakeholders(R & D, Clinical Team, Manufacturing and Quality Assurance team) to
obtain the data for submission.
To involve in planning of site audit/inspection by various regulatory authorities.
Responsible for proofing and approval of artwork.
Communication with the parties outside the India for regulatory submissions.
To review and approval of plant technical documents like BMR, BPR, stability data,
product development report, process validation, hold time etc
To review deviations, change controls through Track wise.
To maintain life cycle management of product through registration, variation,
annual report and renewal/Re-registration submissions.
Supporting on regulatory strategy for the current and new product portfolio.
Interested candidates kindly share your Updated CV to the Mail id :chakradhar.b@hetero.com
