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Post: Head Regulatory & Business Development-MAN002678
No.of post: 01
Job Description
- Registration of Imported Pharmaceuticals and Vaccines.
- Registration of local Biological & pharma Products
- Development of dossiers of local Biological and Pharmaceutical products for Export markets.
- Renewal & maintenance of all licenses - GMP/Manufacturing/Whole sale & others owned by company & CMO.
- Regulatory compliance to import products for clinical trials & CDTL testing.
- Providing requested documents for registration of products in Export markets & approving all artworks & other requisites on timely basis.
- Approval of artworks on imported & local products in accordance with country specific requirements in co-ordination with BU Heads and International Packaging.
- Initiation and co-ordination of Toxicity studies on Pharmaceutical Formulations and raw materials.
- Maintenance of Archives as a disciplined, safe & confidential record keeping
- Ensuring compliance with EHS, OHSAS and ISO standards in RA department.
- Plan and organize with International RA departments by providing current registration (document) requirements of India.
- Obtain required documents from local or International colleagues and submit applications for registration of products.
- To co-ordinate with Marketing for priorities and liaison Manager in Delhi for Registration of products.
- Develop systems and techniques in order to execute tasks which are required to be performed to accomplish RA objectives.
- Lead and develop subordinate to perform RA tasks and establish processes for routine jobs.
- Supervise the tasks performed by subordinates and provide guidance and assistance wherever required.
- Plan budget, and organize equipment / tools to facilitate the efficient working of the RA department.
- To build team-work within the department and facilitate co-ordination of RA team members with other departments.
- Review and approve artworks of products ensuring compliance with Regulatory requirements in co-ordination with Marketing and International Packaging services (Imported products).
- Develop International dossier for local Biological products in co-ordination with GRA Boxmeer.
- Develop dossier of Pharmaceutical products for Exports which meet customer country requirements.
- Co-ordinate with departments within the company and provide regulatory documents for registration of Products for Export markets.
- Coordinate with QC Pharma and outside laboratory to conduct Toxicity studies on Pharmaceuticals / raw materials and include the reports in respective product dossiers.
- Co-ordinate with VSD & technical team for regulatory compliance to conduct clinical trials.
- Maintaining archives of Dossiers of Imported and local products, Technical literatures, Clinical trials / Safety & Efficacy Studies, Stability studies.
- Update documentation and ensure implementation of ISO and EHS standards and conduct audits as internal auditor.
- To be updated with the changes in regulatory requirements and initiate registration applications on time in accordance with current applicable procedures to ensure compliance.
- Expand technical knowledge on local and imported Pharmaceutical and Biological products to facilitate dossier development and registration.
- Developing good rapport with Regulatory authorities and ensuring proper co-ordination to obtain licenses.
- Keeping the team motivated irrespective of Regulatory hurdles faced during the Registration process.
- Acquire technical knowledge & providing required technical supportive data to the queries raised by the authorities especially for new product permissions & NOC.
- Development of new dossiers for all local products especially for old ones where we don’t have these & updating of old ones as per the approved changes.
- Co-ordinate with VSD & technical team for regulatory compliance to conduct clinical trials.
- Increase visibility & Maintain rapport with other organizations like CLFMA,OPPI,IDMA, KOL likeDairy,Poultry, Canine, Equine, Co-Operatives,NGO,Milk Unions,PDFA etc
- Responsible for approval & renewal of physician’s Sample Policy along with country head as per the compliance policy & local laws of land like ma
- Drive pipeline of the company as per the approved five year strategy in coordination with S&M teams as per the products screened year wise.
Additional Information:
Qualification: Science / Pharmacy Graduate, (BVSc, MVSc, PHD Preferred)
Location: Maharashtra- Pune
Functional Area: Manufacturing & Quality
Industry Type: Pharma/Biotech/Clinical Research
End Date: 31st October, 2014
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