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Regulatory Insight Program Manager
1 week ago
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
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