Manager/ Senior Manager - Regulatory Affairs

ProEdge Services
  • Gurgaon
  • Confidential
  • 8-13 years
  • Views
  • 28 Jun 2018

  • Medical Services

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

1) Regulatory Planning Plan, review and recommend the best regulatory strategy for submissions, including regulatory timelines, during the planning phase for pipeline products of assigned portfolio based on regulatory expertise with country regulations & MOH processes; Coordinate the process with other functional members of the affiliate, sites and corporate (Legal, Administration, etc.) to ensure timely availability of required documents and other requirements for dossier preparation; Actively participate in cross-functional teams within the affiliate and provide regulatory expertise and insight to ensure regulatory timelines are met or improved; 2) Submissions and Approvals Prepare a quality regulatory dossier and submit within the planned affiliate timelines; Gain Drug Regulatory Agency's (DRA) approvals to meet the affiliate product launch plans and ensure product maintenance; Provide quality responses to the Ministry of Health (MOH) by the due date; Complete regulatory approval process and gain product licenses; Communicate Product approval; Track post approval commitment; Ensure the local label creation and packaging development will meet local and corporate criteria and supports the business needs; Prepare periodic Regulatory Report of actual submissions and approval and communicate to local management; Provide regulatory metrics on performance that are aligned with Area & IC Regulatory Affairs criteria to measure regulatory performance to Affiliate, Area & Regional management 3) Regulatory Compliance Take appropriate actions to maintain all local marketed products in compliance with local and corporate regulatory requirements; Conduct periodic compliance self-audit to identify potential compliance issues; Perform activities related to pharmacovigilance (PhV) according to Corporate and if applicable, by local regulations; Take corrective actions plans based on regulatory audit findings; Develop, update and implement appropriate SOPs as required by the Global Regulatory Affairs policies (Regulatory Quality Systems), local regulations and acceptable Good Regulatory Practices; 4) Regulatory Influence Establish relationship with key regulatory officials (throughout direct interactions, industry associations, etc.) to influence regulators to foster positive regulatory environment for business and research; Keep updated with current local regulations and DRA organizational structure and potential changes that will impact the business environment, and communicate appropriately to involved or affected parties; Support the development and implementation of the established external regulatory influence strategy; Learn and understand the local affiliate organization and functions; 5) Additional Responsibilities Technically support with Health Economic data for Drug Regulatory Agency price negotiations; Provide regulatory support for locally performed clinical trials (i.e. gain CT approval; CT material labelling, CT licence, etc.

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