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Regulatory Insight Program Manager

5 months ago

Vadodara, India InfoDesk Full time

www.Infodesk.com


InfoDesk is looking for a Regulatory Insight Program Manager to provide and manage projects that meet the custom information needs of high-profile, clientele of global pharmaceutical and biotech companies. This is a unique role and to be successful, you will have a deep understanding of regulatory submissions and requirements or product development, including research, clinical trials, manufacturing practices, regulations and approvals processes to complete the following tasks:


  • Oversee the management and completion of regulatory projects for InfoDesk’s customers in line with customer scope
  • Work directly with InfoDesk customers to establish the scope of work and enable InfoDesk’s teams to fulfil services according to the scope
  • Evaluate applicable laws and regulations to determine impact on company and client activities
  • Identify and interpret relevant regulatory guidelines, as they relate to InfoDesk client projects
  • Advise others on regulatory and compliance matters, as they relate to InfoDesk client projects
  • Explain regulations, policies, or procedures, as they relate to InfoDesk client activities
  • Coordinate regulatory documentation activities, in accordance with client project scopes
  • Provide technical review of data or reports
  • Maintain data in information systems or databases
  • Previous job titles may have included: Clinical Quality Assurance Associate or Specialist, Drug Regulatory Affairs Specialist, Product Safety Specialist, Quality Assurance Documentation Coordinator or Specialist, Quality Assurance/Regulatory Affairs Specialist (QA/RA Specialist), Regulatory Affairs Analyst, and Regulatory Affairs Associate.


Must-Have Skills:

  • BA/BS in scientific/engineering/healthcare discipline, Masters, PharmD or Ph.D preferred
  • 8+ years in the Pharmaceutical Industry or regulatory strategy or similar training/experience
  • Strong knowledge of current North American and EU regulations, and familiarity with international regulations.
  • Knowledge of and broad experience with regulatory procedures and legislation for drug/device development (specifically GxPs), product registration, line extension and license maintenance (US, CA & EU required).
  • Understanding of regulatory controls and marketing pathways of INDs/IDEs/BLAs/NDAs/510(k)s/PMAs, marketing applications and other regulatory submissions and pathways (orphan drug, PRIME, IRP etc)
  • Ability to manage complex projects and timelines in a multinational/multicultural team environment
  • Strong oral and written communication and presentation skills
  • Outstanding attention to detail



Preferred Skills:

  • Regulatory Affairs Certification
  • Experience to include any of the following: a review of product promotional materials, labelling (including change monitoring), batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
  • Knowledge and experience in drugs, biologics, devices or combination products