Regulatory Insight Program Manager

1 week ago

Vadodara, India InfoDesk Full time
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 scopeWork directly with InfoDesk customers to establish the scope of work and enable InfoDesk’s teams to fulfil services according to the scopeEvaluate applicable laws and regulations to determine impact on company and client activitiesIdentify and interpret relevant regulatory guidelines, as they relate to InfoDesk client projectsAdvise others on regulatory and compliance matters, as they relate to InfoDesk client projectsExplain regulations, policies, or procedures, as they relate to InfoDesk client activitiesCoordinate regulatory documentation activities, in accordance with client project scopesProvide technical review of data or reportsMaintain data in information systems or databasesPrevious 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 preferred8+ years in the Pharmaceutical Industry or regulatory strategy or similar training/experienceStrong 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 environmentStrong oral and written communication and presentation skillsOutstanding attention to detail

Preferred Skills:Regulatory Affairs CertificationExperience 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

  • Regulatory Insight Program Manager

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    vadodara, India InfoDesk Full time

    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...

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