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Sr Associate Regulatory Compliance

Gurgaon, HR
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  • Retail & Wholesale
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Job Details

Global Registration and Regulatory Compliance (GRRC) provides global regulatory leadership, expertise, and execution for the information/dossier development, product registration, and lifecycle management.he Local Compliance Specialist GRRC will manage & coordinate local compliance activities.India, Sri Lanka and Bangladesh for products in Air Care and Home Cleaning. This role will serve as single point of contact for all product related compliance inquiries.Directly accountable for registration actions and regulatory compliance for assigned countries (India, Sri Lanka and Bangladesh).Understands and applies relevant internal GRRC processes.Focuses and aligns local activities with regional and global plans and priority lists.Summarizes and communicate regulatory requirements to the Regional manager / Director.Interact with key personnel in regulatory agencies to ensure the timely resolution of issues, and the approval of registration actions. Secures and conducts meetings with regulatory agencies as necessary to achieve registration/compliance drawing on GRRC resources as needed.Provides interpretive analyses of complex regulatory guidance documents, regulations, or directives that impact the companys products and operations, summarize implications for affected functions.Maintains company databases and compliance related IT tools.Proactively ensures necessary data requirements for countries are communicated to region/Racine.Responds to requests from global or regional project teams to provide critical input into registration needs for product launch globally or within region.Continuously evaluates the regulatory climate of the assigned countries, identifies potential issues which may arise, work to favourably impact the outcome of emerging or existing issues.Author required reports that are mandated by local authorities to ensure uninterrupted operation in applicable countriesExecute local compliance in applicable Cluster Lead & Cluster Member countriesCoordinate with HQ on animal study mandates by local governments to be reproduced within that countryTrack the progress of registration applications within Regulatory AgenciesLocalize regulatory documents to fit specifications of the local country Report to respective leadership any related change in regulations or impending new regulationsWhen appropriate, serve on government or industry task forces as a representative of the company in partnership with Government Relations. Seek to favourably impact registration requirements which will benefit regulatory business.3-5+ years of work experience in compliance-related field with progressively broadening responsibilitiesB. Sc or M. Sc degree preferably in a related science (chemistry, biology etc.)Proven situational leadership skills and demonstrated experience in influencing internal stakeholders as well as forging strong relationships with colleaguesSkills to work in an international context with different cultures. Commanding knowledge of compliance requirements in assigned countries.Knowledge of GSARA policies, procedures, processes and SOPsGood communication skills, must be able to summarize and articulate technical information to diverse audiences both verbally and in writingProblem solving skills with the ability to bring project to final conclusion.Self-directed with a can do attitude and willingness to drive change that may not be inspired by him/her and is being asked of him/herMultilingual skills is a plus, especially language(s) of the country being managedTravel RequirementRegionally within Asia
Degree: M.Pharm. (Pharmacy) | M.Sc. (Science)

Additional Degree: B.Pharm. (Pharmacy) | B.Sc. (Science)

Experience: 3-6


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