Search for More Jobs
Forward job to a friend
Apply without Registering
Apply by creating/using an account
Provide Regulatory Support for Current Products and Development Projects
• Provide CMC-related Regulatory support and input.
• Deliver projects and other initiatives to progress current product portfolio by providing CMC-related direction and support to stakeholders.
• Collect and collate CMC data required for registration submissions.
• Prepare CMC-related submission packages for the appropriate Regulatory Agency.
• Correspond with the appropriate Federal or State Agency regarding registration submissions.
• Review product labeling and supporting materials.
• Review and assess relevant change controls (via Trackwise); maintain product compliance summaries (PCS), product registration records (via GRAIS system) and ensure all necessary product-support documentation is accurate and prepared in accordance with agreed timings.
Implement New Regulations and Guidances
• Assess impact of new CMC-related regulations and guidance documents.
• Work with key internal stakeholders (e.g, R&D) to implement requirements within specified timelines.
• Keep current with all relevant guidance documents and regulations while also monitoring any changes that occur which may impact currently marketed Client products.
• Assess and communicate all CMC-related requirements to stakeholders in order to maintain compliance without delay to business due to Regulatory issues.
• Work with Project Managers to adjust and monitor CMC-related timelines to support the business.
Support Infrastructure and Systems Integration
• Contribute to supporting a high quality and effective infrastructure to meet the regulatory requirements which support the launch of associated Client products within North America (US & Canada) and the Caribbean.
• Contribute towards infrastructure projects (processes, procedures, systems etc.) and provide CMC-related perspective.
• Deliver project- and brand-specific activities assuring they are correct, complete and on-time including registrations, submissions, labeling/advertising initiation/reviews, etc.
Gain Understanding of Legislative and Regulatory Climate
• Understand how the government operates and key touch points Client can access to influence policy development. Monitor trade associations and task forces that support Client.
• Monitor ongoing legislative and competitive developments.
• Monitor and gain an understanding of new policies and objectives involving federal and local government affairs.
• Review trade association materials (newsletters, meeting minutes, agenda items) to gain an understanding of where influencing opportunities exist.
• BA/BS degree required in the natural sciences.
• A minimum of 3 years of relevant work experience required.
• Experience with FDA registered products is required.
• Experience in CMC Regulatory and/or equivalent is highly preferred (experience in R&D is plus).
• High attention to detail and strong organization skills.
• Ability to establish close communications and working relationship with cross functional teams to meet business objectives.
• Ability to work with uncertainties and effect innovative solutions to complex regulatory requirements.
• Strong verbal and written communication skills.
• Strong negotiating, influencing and interpersonal skills.
• Results oriented, entrepreneurial and self-motivated.
• Excellent computer skills (Microsoft Office suite).
• Experience with electronic document management and submissions (e.g., eCTD) desired.
Apply by creating/using an account