Director of CMC Regulatory
Position Title: Director of CMC Regulatory
Reports To: Chief Operating Officer
Status: Full Time, Exempt
The Director of CMC Regulatory works closely with other functional groups to develop and implement regulatory strategies to manage a product (drug, device, and drug-device combination) through its lifecycle, often in coordination with company partners. They plan and author high-quality regulatory submissions and interactions to health authorities in US and Globally. This role manages regulatory submissions that meet aggressive timelines, are consistent across development programs, and are established on a sound scientific basis.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Develop and implement CMC regulatory strategies for new and existing products throughout their lifecycle
- Work cross-functionally and with external partners to plan and produce high-quality regulatory submissions while meeting aggressive timelines.
- Author and review technically complex CMC sections for regulatory dossiers for investigational applications, marketing authorization applications, post-approval variations, responses to agency questions, etc. for submissions in US and international markets.
- Ensure regulatory submissions are in-line with ICH guidances, local statutory requirements, scientific principles, and business policies and procedures.
- Ensure consistency is maintained in regulatory submissions across development and commercial projects and that sound scientific justification is employed in CMC regulatory strategy.
- Support and manage CMC-related activities (e,g., post approval changes, change controls, FDA information requests, etc.) for drug substance and products based on scientific knowledge, control strategies, regulatory and quality compliance.
- Apply up-to-date knowledge of regulatory and quality compliance requirements and communicate changes in regulatory information to project teams and management.
- Initiate and contribute to process improvements, which have a significant impact on the overall efficiency of the regulatory submission process.
- Engage with the contracted manufacturing organization(s) to manage change controls and evaluate for regulatory implications.
- Focus on organizational excellence; Coach and develop staff with skills in operational, technical, and regulatory leadership to make good, timely decisions and achieve impactful outcomes.
- Represent CMC Regulatory in multiple development and/or commercial project teams, which include due diligence and strategic activities.
- Bachelor’s degree, with advanced degrees and/or certifications a plus (e.g., RAC)
- 10-15 years’ experience in the FDA-regulatory industry
- At least 5 years managing people and/or projects
- Pragmatic and goal-oriented
- Prior experience in a relevant lab or manufacturing environment is preferred
- Prior experience in regulatory or quality function is required; global experience is preferred
- Experience with drugs, devices, and/or combination products in an FDA-regulated industry preferred
- Strong background in CMC regulatory activities
- Strong understanding of GxP (especially GMP)
- Previous experience with IND, NDA, and/or ANDA submissions
- Strong technical writing skills (e.g., SOPs, policies, regulatory communications, deviations)
- Strong communication skills (e.g., trainings, presentations, and/or interactions with health authorities)
- Previous experience participating in regulatory inspections of manufacturing facilities
- Experience with an EDMS (e.g., Veeva)
- Proficiency with Microsoft Office and Adobe Acrobat
- Ability to work well in teams and independently, both within the company and with external partners
- Ability to travel, both internationally and domestically
Medicines360 is committed to a diverse workplace and is committed to equal opportunity employment for all job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Medicines360 complies with all applicable local, state and national laws governing nondiscrimination in employment.