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Watson Pharama
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Mgr Regulatory Affairs

Mgr Regulatory Affairs

Watson Pharama

10 - 15 years

17 - 19 Lacs

bengaluru

Posted:13 hours ago| Platform:

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Skills Required

product launch medical devices usage sap compliance pharma healthcare regulatory affairs monitoring recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

Management of the submission and approval process for Teva products in APAC Region (Australia, New Zealand, Singapore, Malaysia etc) to support business opportunities for the company.

Management of regulatory compliance including product maintenance, data sheets, labelling, regulatory compliance files and regulatory databases.

Support new product launch activities including coordinating regulatory requirements, artwork approval and providing technical input into any product related materials required for market introduction.

How you ll spend your day

Regulatory Submissions

Manage all submissions and maintenance activities related to Branded/Specialty and Generic products in APAC region.

Ensure full compliance of marketed products according to local regulations by proactively managing and monitoring change control with sites/suppliers and global RA WP. Manage local regulatory planning process for post-approval changes, including variations, site transfers and compliance related activities to support supply continuity.

Manage activities within Regulatory Systems and keep up to data as per compliance requirements (GRIDS, GI Insights, Teva Art, Veeva etc)

Regulatory Intelligence / Expertise / Guidance / Education

Provide regulatory guidance to ensure that Teva can meet the responsibilities of an importer, distributor and sponsor, to ensure supply of safe and effective medicines, including supply of unapproved medicines, as required by Health Authorities

Provide regulatory intelligence and maintain thorough and up-to-date understanding of the regulatory environment in APAC region by providing impact analysis feedback to commercial teams. .

Capture monthly activities via reports and capture RA activities on an ongoing basis in the regulatory tracking system.

Ensure regulatory records and files are maintained electronically for ready record retrieval and life cycle management, in accordance with global and local requirements.

Monitor, collect and interpret regulatory guidelines and trends that will impact marketed and planned products, share this information with appropriate personnel and assist in the development of strategies and plans of action to address them.

Work closely with market RA in APAC region to complete all assigned activities

Your experience and qualifications

B. Pharm / M. Pharm (preferred) with 10+ years of experience

Good knowledge and understanding of pharmaceutical & scientific processes as well as registration and assessment of human medicinal products and medical devices.

Experience in Generics, Biosimilars or Innovative Medicines in Regulatory Affairs (APAC preferred) and knowledge of regulatory and healthcare system in APAC (Australia, New Zealand, Singapore, Malaysia etc)

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