Senior Regulatory Affairs

14 hours ago

Gurgaon, Haryana, India SAR HR Consultancy Full time ₹ 15,00,000 - ₹ 25,00,000 per year
Company Overview:
At SAR HR Consultancy, we specialize in providing strategic regulatory affairs solutions to our clients in the None industry. As a trusted partner, we aim to facilitate compliance with international regulations and optimize business systems and processes. We are currently seeking a highly skilled Senior Regulatory Affairs (International) professional to join our dynamic team.
Role and Responsibilities:
In this role, you will be responsible for analyzing and evaluating user business problems, and developing effective business system or process recommendations that align with regulatory requirements. Your key responsibilities will include:
  • Working on compliances and international regulatory affairs, with a focus on diagnostic products rather than drugs
  • Staying updated with international regulations and effectively managing 30+ channel partners globally
  • Knowledge of registering IVD products and familiarity with terminologies such as V&V report and Stability Report
  • Managing projects independently, including project planning, resourcing, progress reporting, issue resolution, and delivery of results
  • Ensuring effective communication across teams and functions, keeping management informed of progress, key issues, and any changes that may impact the business
  • Leading business process-related projects, coordinating with other functions to drive successful outcomes
  • Solving a broad range of system and/or workflow problems of varying complexity
Candidate Qualifications:
To be successful in this role, you should possess the following qualifications:
  • Bachelor's or Master's Degree or University Degree or equivalent
  • At least 4+ years of relevant experience
  • In-depth knowledge and experience in regulatory affairs, with the ability to work independently
Required Skills:
  • Compliance management
  • Knowledge of international regulatory affairs
  • Project management
  • Registration of IVD products
  • Effective communication and leadership

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