Director / Senior Director, Global CMC Regulatory Strategy

i-Pharm Consulting; Boston (MA); Hybrid; USD 180,000 - 260,000; Full time

Job summary

i-Pharm Consulting seeks an experienced Regulatory Affairs CMC leader to shape global CMC regulatory strategies for clinical development, market applications, and lifecycle management. This senior role collaborates with Operations, Quality, Development, Manufacturing, and Supply Chain to ensure favorable regulatory outcomes across programs.

The position offers a hybrid work model with regular onsite presence in the Greater Boston Area.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Chemical Engineering, or a related scientific discipline.
• Advanced degree (MS, PharmD, PhD, or equivalent) preferred.
• Director level: typically 10+ years of regulatory affairs/CMC-related experience in pharma/biotech.
• Senior Director level: typically 15+ years with extensive Regulatory CMC leadership responsibilities.
• Strong knowledge of global CMC regulations, guidelines, and development requirements.
• Experience supporting both clinical-stage and commercial products.
• Experience authoring, reviewing, and managing CMC sections of global regulatory submissions.
• Proven experience interacting with regulatory authorities on CMC-related matters.
• Strong project leadership, communication, and stakeholder management skills.

Responsibilities

• Develop and execute global Regulatory CMC strategies for investigational, registration, and marketed products.
• Provide strategic regulatory guidance throughout development, commercialization, and lifecycle activities.
• Lead CMC regulatory planning and support for global submissions (clinical trials, marketing applications, variations).
• Collaborate with cross-functional teams to develop and approve CMC documentation and dossier content.
• Ensure submissions comply with global regulations, guidelines, and regional requirements.
• Represent Regulatory CMC in interactions with health authorities and regulatory meetings.
• Assess regulatory implications of manufacturing, analytical, process, packaging, labeling, and supply chain changes.
• Partner with Quality and Technical Operations on change controls, deviations, and inspections readiness.
• Identify regulatory risks and communicate recommendations to senior leadership.
• Monitor evolving regulatory requirements and translate insights into actionable strategies.
• Provide leadership and SME mentorship within Regulatory Affairs.

Skills

Regulatory strategy

CMC leadership

Cross-functional collaboration

Regulatory submissions

Stakeholder management

Regulatory authority interactions

Education

Bachelor's degree in Life Sciences or related

Advanced degree preferred

Job description

i-Pharm Consulting seeks an experienced Regulatory Affairs CMC leader to shape global CMC regulatory strategies for clinical development, market applications, and lifecycle management. This senior role collaborates with Operations, Quality, Development, Manufacturing, and Supply Chain to ensure favorable regulatory outcomes across programs.

The position offers a hybrid work model with regular onsite presence in the Greater Boston Area.