Hetero Released Job Openings On 23/01/2023. Hetero is an Indian pharmaceutical company and the world’s largest producer of anti-retroviral drugs. Hetero’s business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics.Interested and eligible candidates can submit application along with resume.
Vacancy Details:
Hetero Recruiting Any Graduates with 02-07 Years experience for Regulatory-Affairs-CMC-DP Department.Complete Details for the Regulatory-Affairs-CMC-DP as follows.
Important Details :
- Location : Jadcherla
- No of Vacancies:Not Disclosed by Recruiter
- Details of Salary: ₹ 50,000 – 3,00,000 P.A.
- Opening date for online Application:23/01/2023
- Contact :Interested candidates can share the cv to the mail ID :Chakradhar.b@hetero.com
Related Job : Laurus Labs Online Recruitment – Email Resume
Job Description/Skills Required
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.
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