Associate Director, Regulatory Affairs - CMC

The Role:

Reporting to the Senior Director, Regulatory Affairs & Global CMC Lead, the Associate Director, Regulatory Affairs-CMC will play a key role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs.   This role is accountable for the planning and technical execution of the CMC regulatory strategy and for representing Regulatory Affairs-CMC in cross-functional teams and with external partners.  The successful candidate will have a strong background in Regulatory Affairs-CMC with a focus on small molecule clinical (IND/IMPD) and commercial (NDA/MAA) submissions.

 Responsibilities:

• Serve as regulatory CMC lead for assigned projects.
• Provide strategic regulatory CMC leadership, consultation, and guidance to project teams.
• Develop and execute CMC global submission plans and timelines in accordance with project goals.
• Lead the preparation, review, and submission of CMC sections for NDAs/MAAs, INDs/IMPDs/CTAs, and other global regulatory filings.
• Manage health authority meetings including the preparation of meeting requests and briefing documents.
• Triage and coordinate responses to CMC questions/requests for information from regulatory authorities.
• Manage regulatory assessment and guidance on product compliance topics, including change controls, deviations, and GMP investigations.
• Lead projects with cross-functional teams and act as the primary regulatory CMC contact and bridge between CMC Tech Ops and regulatory affairs and program management.
• Contribute to initiatives to improve processes and procedures within the Regulatory Affairs department.
• Keep abreast of regulatory guidance and technical/scientific developments relevant to projects.
• Proven ability to lead and manage regulatory CMC projects.
• Demonstrates leadership skills as a regulatory CMC expert on project teams.
• In-depth knowledge of global CMC regulatory requirements and guidelines (e.g. FDA, EMA, ICH).

Competencies Include:

• Possess excellent problem-solving abilities.
• Excellent organizational and communication skills, both written and verbal.
• Positive attitude, energetic and proactive.
• Strong attention to detail and the ability to multi-task in a fast-paced environment.
• Strong interpersonal skills and the ability to effectively work individually, within a cross-functional team.
• Strong technical writing and document review skills.

• Demonstration of strategic thinking and high-level planning while also balancing the ability to manage and execute operational details.
• Ability to effectively manage multiple projects with competing priorities.

 Qualifications:

• Bachelor of Science degree in a field related to pharmaceutical sciences.
• 6-8+ years of experience in Regulatory-CMC or within a CMC function (e.g. Analytical, Formulations, Process Chemistry, QA, QC) in the biotech/pharmaceutical industry with a focus on CMC for small molecules.
• Experience with NDA submissions is required.
• Knowledge of eCTD Module 3 and QOS requirements for INDs/IMPDs and NDAs/MAAs.
• Knowledge of current regulatory guidelines (FDA/ICH) pertaining to drug development, with particular emphasis on CMC/Quality.
• Experience with review and/or providing content for CMC/Quality regulatory submissions, including IMPD and IND development/maintenance. 
• Experience with writing and leading NDA Module 3 sections is required.

Last updated on Aug 21, 2024