Senior Manager, Regulatory Project Management, Global Regulatory CMC

The Role:
We are seeking an experienced and dynamic Regulatory CMC Project Senior Manager to join our team. In this role, you will manage regulatory submissions related to Chemistry, Manufacturing, and Controls (CMC) for the development and commercialization of biopharmaceuticals, biologics, or small molecules. You will lead cross-functional teams to ensure timely, high-quality regulatory submissions and approvals, and manage project timelines and submission-related processes. 

The ideal candidate will have a strong background in CMC regulatory submissions, project management, and a deep understanding of global regulatory submission frameworks (FDA, EMA, ICH, etc.). You will be instrumental in supporting the launch of innovative therapies and ensuring that they meet both internal and regulatory standards across multiple markets.

Here’s What You’ll Do:

• Regulatory CMC Project Management:

• Lead and oversee the tactical management of CMC regulatory submissions for assigned drug development programs.

• Ensure the successful execution of regulatory submission milestones for CMC documentation, including Investigational New Drug (IND) applications, Biologics License Applications (BLA), Marketing Authorization Applications (MAA), and variations.

• Regulatory Submissions & Documentation:

• Manage the preparation, review, and submission of CMC sections for regulatory filings (IND, CTA, NDA, MAA, BLA, etc.) in compliance with global regulatory requirements and support the integration of project plans.

• Coordinate regulatory responses to Health Authority inquiries related to CMC filings.

• Cross-Functional Team Leadership:

• Collaborate closely with Reg CMC and Technical Development to ensure regulatory CMC deliverables are aligned with product development and submission timelines.

• Facilitate effective communication across functional teams to ensure consistency in regulatory submissions and approvals.

• Project and Risk Management:

• Oversee the planning, tracking, and execution of CMC regulatory project timelines, identifying and mitigating potential risks that may impact project deliverables.

• Manage efforts to streamline regulatory CMC processes and ensure effective coordination between teams and external partners.

• Coordinate the timely resolution of CMC regulatory issues, including the preparation of risk assessments and contingency plans.

• Regulatory Intelligence & Training:

• Maintain up-to-date knowledge of regulatory guidelines, CMC-related regulations, and health authority requirements globally.

• Provide training and development opportunities for junior regulatory staff on CMC regulatory submission matters and best practices.

Here’s What You’ll Bring to the Table:

• Education:

• Bachelor’s degree in life sciences, chemistry, pharmacy, biochemistry, or a related field;

• Additional certification in regulatory affairs (e.g., RAC – Regulatory Affairs Certification) is a plus.

• Experience:

• Minimum of 8 years of experience in Regulatory Affairs/ or Project Management with a focus on CMC, and at least 5 years in a project management role.

• Experience with regulatory submissions for biologics, biosimilars, or small molecules (IND, NDA, MAA, BLA, variations, etc.) is essential.

• Strong understanding of CMC-related regulatory requirements across major global markets (FDA, EMA, ICH, etc.).

• Previous experience in managing processes for submissions within cross-functional teams and leading complex projects with global scope.

• Skills & Competencies:

• Strong submission leadership skills with experience managing cross-functional teams in a regulatory setting.

• Excellent project management skills, with a proven ability to deliver projects on time, within scope, and within budget.

• In-depth knowledge of CMC regulations, good manufacturing practices (GMP), and quality systems.

• Ability to navigate and resolve complex regulatory challenges, particularly related to CMC issues.

• Strong written and verbal communication skills, with the ability to effectively present complex regulatory information to internal and external stakeholders.

• Detail-oriented with strong organizational and multitasking capabilities.

• Ability to manage multiple projects simultaneously, ensuring strategic alignment and delivery within scope and deadlines.

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