Director, Regulatory Affairs, CMC (Biologics) - Remote
Regulatory Professionals, a division of Premier Research, is a consultancy firm specializing in drug, biologics and device regulatory affairs. Our purpose as a company is to support our clients by furthering the development of human therapeutics that will benefit the health and well-being of patients around the world. With a presence in the US, EU, Canada and Australia we are growing and looking for talented people to grow our business, advance the goals of our clients and contribute to our unique culture. Our focus is to provide strategic and tactical support in all aspects of regulatory affairs, including preclinical, CMC and clinical development for drugs, biologics, devices, and combination products.
We’re looking to hire a talented and energetic Director, Regulatory Affairs Chemistry, Manufacturing and Controls to join our innovative team.
As the Director, Regulatory Affairs Chemistry, Manufacturing and Controls (RACMC), you’ll have the opportunity to oversee and direct all CMC regulatory strategies. You’ll provide strategic input, perform risk assessments, and oversee preparation of CMC regulatory submissions. You’ll also collaborate with functional areas to provide regulatory guidance on quality related issues, provide the best possible CMC regulatory strategies that integrate with plans for other disciplines and company objectives, and to ensure timely and accurate preparation and review of regulatory submissions and related CMC documents. Finally, you will be able to supervise or manage others within the RACMC skill group.
This position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities. Accommodations for new hires who have qualifying medical conditions or sincerely held religious beliefs that conflict with this requirement will be considered on an individual basis.
What you’ll be doing:
- Function as RACMC lead for assigned products and regions
- Provide strategic RACMC interpretation and guidance to project teams from early development through post-approval
- Develop and execute the regulatory strategy (CMC aspects) to support the lifecycle of assets; determine from a strategic and scientific perspective the content of relevant CMC sections (technical and/or procedural) of project/product specific documents submitted to regulatory agencies (e.g. NDA, MAA, INDs, IMPDs, etc.) and ensure that these documents meet high scientific standards and regulatory requirements
- Lead project/product-related discussions and provide strategic, scientific and regulatory input, for RACMC and/or procedural aspects
- Direct creation of and update to quality sections of regulatory filings; compile/write/review high quality project/product specific CMC documents to be submitted to regulatory agencies and ensure that those documents meet regulatory requirements; review quality submission documents to ensure consistency with related filings, industry standards and regulatory requirements
- Review CMC protocols/test methods; review and approve clinical manufacturing plans and labeling, and authorize drug shipment to clinical sites
- Interact with manufacturing and quality groups, regulatory agencies, contract and partner organizations, regarding RACMC issues; assess impact of manufacturing changes pertaining to approved commercial products
- Interface with international affiliates on regional regulatory strategy and implementation plans
- Conduct business development efforts
- Effectively communicate comments/recommendations and proactively engages program teams to establish solution to issues
- Provide coaching, mentoring and knowledge sharing within the RACMC skill group
- Review and approve timesheets and expense reports and guiding the performance of assigned staff
You’ll need this to be considered:
- Bachelor’s degree, or international equivalent, in a science or health related field; PhD preferred, along with 12+ years of experience in the CRO, pharmaceutical, biotechnology or device/diagnostics industry (an advanced degree will be considered in lieu of a portion of industry experience); 8-9 years of RACMC experience in a CRO, pharmaceutical, device/diagnostics or biotechnology company; 6-7 years supervisory/management experience
- Advanced knowledge of regulatory requirements, including ICH and FDA
- Diverse experience including drugs, biologics, devices and international filings preferred
- Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously
- Results driven and team oriented, with the ability to influence outcomes as necessary
- Able to develop and implement creative approaches to ensure regulatory success
- Able to innovate, analyze, and solve problems with minimal supervision
- Exceptionally keen attention to detail
- Demonstrated ability to manage a staff of up to 5 employees to achieve company and client goals
- Biologics experience required