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Post: RA Manager India (16026)
Job Description
1. To ensure compliance of the local Merck CH product portfolio to applicable regulations, guidelines and Merck standards.
2. To prepare and submit dossiers for registration and compliance and to achieve registrations for the specific product portfolio, within agreed timelines. This includes:
- Defining the requirements for local submission of registration dossiers (when needed in cooperation with 3rd parties or consultant)
- Defining the requirements for products which do not required submission (when needed in cooperation with 3rd parties or consultant)
- Dossier compilation, authoring, regulatory compliance and publishing using electronic databases and repositories.
- Submission of registration dossiers to achieve registrations and/or - for products which do not require submission - performing the necessary actions required to ensure compliance of the product (dossier or document review for internal filing, product notification, etc.)
- To update and maintain dossiers post registration. This will include the submission of variation documents.
- To ensure the renewal of registration of products by defining the accurate timelines.
- To ensure maintenance and update of regulatory files and records including appropriate archiving of all relevant documentation in appropriate systems in line with applicable internal company standards, and updating regulatory data records (RIMS).
3. To advise organization of potential regulatory risks in normal day to day activities and recommend compliant actions.
4. To review and ensure the conformity of the product artworks, promotional material and tools with the marketing code and legal requirements.
5. To liaise with health authorities, distributors, regulatory authorities, trade associations and contract manufacturers in the region, in order to achieve and maintain registrations.
6. To develop relationships with regulatory and industry bodies in order to represent the interests of the organization, gain relevant information and help shape change.
7. To maintain and provide required licenses for proper functioning of the company, like GMP certificate, manufacturing license, CPPs (if country of reference), special functioning licenses
8. To provide relevant regulatory advice in product development projects.
9. To keep abreast of the dynamic regulatory, compliance and statutory requirements in the global, regional and local environment in order to ensure organizational compliance.
Additional Information:
Req ID: 16026
Location: Maharashtra
Functional Area: DRA
Industry Type: Pharma/Biotech/Clinical Research
End Date: 11th March, 2014
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