Executive / Sr. Executive / Asst Manager (Regulatory Affairs)

Cronus Pharma

2 - 7 years

5 - 12 Lacs

hyderabad

Posted:1 month ago| Platform:

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Skills Required

regulatory affairs centre for veterinary medicines guidelines product license dossiers ctd license renewals customer practice

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Ensure that a company's products comply with the regulations of the regions.
Keep up to date with national and international legislation, guidelines and customer practices
Respond to queries from Centre for Veterinary Medicines (CVM).
Collect, collate and evaluate scientific data from FR&D, AR&D and DQA.
Develop and write clear arguments and explanations for new product licences and licence renewals at R&D site.
Prepare submissions of licence variations and renewals to strict deadlines as per CVM.
Monitor and set timelines for licence variations and renewal approvals
Advise scientists (AR&D, FR&D, Pkg.-R&D) on regulatory requirements.
Provide strategic advice to senior management throughout the development of a new product
Review company practices and provide advice on changes to systems if any.
Liaise with manager, and make presentations to, regulatory authorities, if any.
Negotiate with regulatory authorities for marketing authorisation
Take part in the development of marketing concepts and approve packaging and advertising before a product's release.
Prepare the CTD sections of the dossier and ensure timely filing as informed by the functional head and Head -R&D.
Review the data and check for its alignment and compliance from regulatory point of view as per CVM.
Ensure the regulatory filing grid as shared by Functional head and Head-R&D is met on timely way and in complete regulatory compliance.
Collaborate with FR&D, AR&D, Pkg-R&D on regular basis and together ensure the timely filing of products.

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