Healthcare Regulatory Manager providing consulting services within the Healthcare practice at RSM. Responsible for regulatory compliance and reimbursement consulting for healthcare clients.
About the role
- Director of CMC Regulatory Affairs managing regulatory strategies and team for pharmaceutical/biotech company. Oversee global regulatory submissions and compliance activities with authorities and internal teams.
Responsibilities
- Oversee the assigned CMC/CP Regulatory Affairs team, driving global regulatory strategies and operational direction for the assigned portfolio, including initial clinical registrations, market application approvals, and post-approval lifecycle management
- Lead the preparation, review, and submission of regulatory documents (e.g., meeting packages/briefing book, scientific advice, BLAs, MAAs, BPDRs, supplements) to regulatory authorities
- Provide scientific and regulatory inputs for the assigned portfolio to facilitate and expedite the development and marketing of drugs and/or biologics
- Oversee and direct interactions with global regulatory authorities, including meetings, information request responses, and inspections
- Direct and provide advice on the compliance activities (e.g., change controls, deviations) for the assigned portfolio, evaluating regulatory impacts and associated submission requirements for clinical and commercial regulatory filings in accordance with country-specific guidelines
- Develop and implement department objectives and work plans, delegate responsibility effectively, and prioritize team workloads to meet organizational goals
- Provide leadership by contributing to departmental strategy, organizational goals, and policy development
- Guide team members to address complex and unprecedented program challenges, ensuring timely resolution
- Participate in cross-functional groups and working groups to improve current practices and establish new processes/procedures
Requirements
- A bachelor’s degree with a minimum of 10 years of pharmaceutical/biotech industry experience, including a minimum of 8 years of relevant CMC experience
- Alternatively, a master’s degree with 8+ years of experience, or a PhD degree with 3+ years of experience
- At least 3 years of applicable managerial experience
- Proven track record of supporting biological products and/or small molecule drugs through development and approval
- Strong understanding of current CMC / CP worldwide regulations
- Successful leadership in delivering CMC/CP sections of marketing authorizations, clinical trial applications (CTA/IND), and post-approval submissions for biological products, combination products, and/or small molecule drugs
- Previous experience with device regulatory requirements and development processes for combination products
- Human Factors experience is a plus
- Experience in dealings with the FDA and other regulatory authorities
- Experience managing and developing staff members
Benefits
- health and wellness programs (including medical, dental, vision, life, and disability insurance)
- fitness centers
- 401(k) company match
- family support benefits
- equity awards
- annual bonuses
- paid time off
- paid leaves (e.g., military and parental leave)
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