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Regulatory Affairs Specialist

2 months ago

India Product Life Group Full time

Required technical skills :

Lifecycle maintenance experience

Providing support during external and unannounced audits.

Responding to internal requests for technical and/or regulatory information.

Assisting with license applications as required.

Preparation and submission of documentation for post-approval applications including, but not limited to Variations, Renewals, MAH Transfers/COAs

Preparation and submission of Technical/Site Transfer Applications

Assisting with the preparation of Marketing Authorisation Applications

Monitor and maintain up-to-date knowledge of national, European and International guidelines/legislation.

Ensuring compliance with all regulatory processes, in readiness for both internal and external audits.

Ensuring compliance with the regulations of the assigned Countries within the European and International Regions

Use a variety of software packages to produce correspondence and documents, maintain

A proven ability to consistently deliver to tight timelines, without negatively impacting on quality or departmental budget

General regulatory administration duties and compliance requirements

Management of artwork generation/ labelling/creation/update of product information (at least 3-5 years)


Additional experience and/or skills :

6 + years of RA experience in APAC Region

Good IT skills/knowledge

Good organizational skills

Good communication skills

Pro-active attitude and able to work on own initiative as well as part of a team

Ability to prioritize different workloads/multi-task

Personal responsibility for ensuring a high standard of work

Hands-on experience of product launches within European and International regions