Senior Specialist, Regulatory Affairs CMC

World Courier

2 - 5 years

4 - 7 Lacs

noida

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Skills Required

commercial marketing medical devices head business development strategy implementation legal cmc cosmetics veterinary regulatory affairs operations

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Details

Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead.
Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products with emphasis on CMC aspects.
Support with preparation, review and compilation of CMC documents within the framework of regulatory affairs projects.
Communicate with clients and Health Authorities in close cooperation with the respective lead.
Support with the planning and execution of client projects in accordance with KPIs in close cooperation with the respective lead.
General guidance (consultancy) of colleagues and clients regarding CMC Services.
Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues.
Support with VDC strategy implementation and optimization.
Comply with and support the maintenance of internal procedures.
Provide operational insights to support with VDC led commercial, marketing and business development activities including proposal input in close cooperation with the respective lead.
Support respective lead in delivery to budget with accurate and timely reporting and provide project insights to address invoicing queries.
In agreement with Head of VDC REG providing on-site regulatory support to GCS clients.
The employee agrees to take over other reasonable tasks that are corresponding with their abilities upon agreement with their Line Manager/Practice Area Lead/Head of VDC REG.

Handling of M3 databases
Compilation/handling of wToCs for renewals/variations
Drafting of eAFs and country information letters for dispatch packages
Communication with local affiliates regarding local requirements
Change assessments according to EU variation guideline
CMC background preferred, IT affinity, very detail oriented, excellent communication skills
Maintain knowledge and understanding of SOPs and current regulatory guidelines as applicable.

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