Regulatory Affairs - Asst. Manager, Senior Executive,

Maan Pharmaceuticals; Mumbai; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Maan Pharmaceuticals in Mumbai requires a regulatory affairs professional to manage product registrations across multiple countries. The role involves preparing and submitting registrations, coordinating with authorities, and ensuring compliance of COAs for dispatch of orders.

You will work with CTD formats, maintain dossiers, and contribute to SOP updates while potentially traveling for audits as needed.

Qualifications

• Experience in product registration and regulatory submissions across countries.
• Proficient in CTD formats and dossier preparation.
• Ability to check COAs and ensure compliance for dispatch of orders.

Responsibilities

• Prepare and submit product registrations to authorities across countries.
• Coordinate submissions, timelines and approvals with the concerned person.
• Work with CTD formats and dossier preparation.

Skills

Regulatory submissions

CTD formats

Dossier preparation

Audit coordination

SOP writing

Job description

Role & responsibilities

• Product Registration as per registration guidelines of different countries and regulatory submission. Prepare and submit variations to authorities. Follow up on submissions, timelines and approvals, with the concerned person
• Well versed with CTD formats and dossier preparation
• Ensuring samples are sent timely and coordinating with concerned person for submission, getting the receipts and follow-up on the registrations
• Checking COAs before dispatch of Commercial Orders
• Application of Product Permissions, COPPs, and coordination for addition of New Products in WHO GMP List
• Checking of Artwork, Leaflets of both International and Domestic Supplies
• Participate in writing and update SOP/Work Instructions and process improvements
• Travel to Manufacturing Units during the Audit by External Agencies

Preferred candidate profile

* Takes full responsibility of getting the documents organised and filing the product for registration at various countries Ministry of Health

* Willing to travel to manufacturing unit during International Audits for 5 to 7 days on comany account.