Regulatory Associate CMC Job Responsibilities
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 RB 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 RB 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
Education & Qualifications
- Understand how the government operates and key touch points RB can access to influence policy development. Monitor trade associations and task forces that support RB.
- 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.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.