Assistant Manager - Regulatory Affairs - Apparel Group India pvt. ltd. - Gurgaon, Haryana
India
about 2 years ago
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Summary
Roles & Responsibilities:
Proactive planning for all regulatory submission as per business requirement & new requisition.
Compilation and review of registration application (like Form COS 1), online uploading of documents on SUGAM Portal.
Drafting of all regulatory/administrative documents (eg. POA, Undertakings, Part-1, Cover letters etc.) to get the registration certificate for various application regarding cosmetics and query response as well.
Preparation and submission of query response to DCGI (Drug Controller General of India) for cosmetic application.
Regulatory follow up with CDSCO office for status of applications and for any new update regarding our registered products.
Maintain documentation related to submitted applications including progress & record tracker.
Experience, Qualification & Skills:
B Pharm/ M Pharm with experience of pre-market & Post Market regulatory work on compliance to Cosmetic rules 2020, Drug & Cosmetic Act & Rules governed by CDSCO (Central Drug Standard Control Organization).
Should have knowledge about Cosmetic rules 2020 and Drug & Cosmetic Act & Rules.
Good Communication & interpersonal Skills
MS Office
Job Type: Full-time
Pay: ₹500,000.00 - ₹800,000.00 per year
Benefits:
Health insurance
Schedule:
Day shift
Monday to Friday
Supplemental Pay:
Quarterly bonus
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