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Senior Specialist, Regulatory Affairs

Senior Specialist, Regulatory Affairs

World Courier

3 - 5 years

5 - 7 Lacs

noida

Posted:3 hours ago| Platform:

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Skills Required

commercial marketing medical devices strategy implementation legal cosmetics archiving veterinary regulatory affairs operations recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Details

Labeling Specialist responsible for Pre-evaluation of Reference Country Strategies, Deviation creation, Pre-evaluation of DLs, CCDS Update process till Global Dispatch, Binder creation, Attending Product PET meetings, Literature search , GLS QA check for Labeling Deviations Dashboard, Internal GLM meetings, Labeling Support, Pre-Evaluation of Prior Submission Deviations, Internal QA Check of Global Labeling documents, Drafting of Global Response Documents, Drafting of PET Meeting Minutes and PET Written Reviews, Email Archiving activities.
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.
Support with preparation, review and compilation of 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 Regulatory Strategy and Procedure Management.
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.

Qualification & Experience

3-5 years of experience, or demonstrable capability, in area of responsibility or similar field; advanced knowledge and insights required to perform processes efficiently and proven potential to take over more complex tasks.
University degree in Life Science.

Skills Required

Ability to deliver on customer or internal projects / processes within daily work; ability to prioritize parallel tasks, escalate issues where appropriate and to offer solutions for appropriate counter measures.
Structured and systematic and independent way of working; limited latitude within established set of procedures, may determine priorities with little supervision.
Ability to analyze and solve problems and to offer solutions for a given task or project. Attention to detail. High service orientation
Ability to train and support junior/new colleagues in daily activities; ability to lead small projects with clearly defined scope.
Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as clients team lead level.
Good communication skills (written and verbally); capability to communicate issues and propose solutions. Confident appearance.

What Cencora offers

Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Full time

Affiliated Companies Affiliated Companies: PharmaLex India Private Limited

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