Director / Senior Director, Regulatory Affairs CMC (Small Molecule)

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

We are seeking an experienced Regulatory Affairs CMC leader to provide strategic, operational, and tactical regulatory support across development-stage and commercial pharmaceutical programs. This individual will play a key role in shaping and executing global CMC regulatory strategies that support clinical development, marketing applications, lifecycle management activities, and post-approval requirements.

The successful candidate will serve as a core member of cross-functional teams, partnering closely with Technical Operations, Quality, Pharmaceutical Development, Manufacturing, Supply Chain, and other functional stakeholders to ensure successful regulatory outcomes across multiple programs and regions.

Depending on experience, this role may be hired at either the Director or Senior Director level.

Key Responsibilities

• Develop and execute global Regulatory CMC strategies supporting investigational, registration, and marketed products.
• Provide strategic regulatory guidance throughout product development, commercialization, and lifecycle management activities.
• Lead CMC regulatory planning and support for global submissions, including clinical trial applications, marketing applications, supplements, variations, amendments, and other post-approval filings.
• Collaborate with cross-functional teams to develop, review, and approve CMC regulatory documentation and dossier content.
• Ensure regulatory submissions comply with applicable global regulations, guidance documents, and regional requirements.
• Represent Regulatory CMC in interactions with global health authorities and contribute to preparation for regulatory meetings and responses to agency questions.
• Assess regulatory implications of manufacturing, analytical, process, packaging, labeling, and supply chain changes.
• Partner with Quality and Technical Operations teams to evaluate regulatory impact related to change controls, deviations, investigations, and inspection readiness activities.
• Identify regulatory risks, develop mitigation strategies, and communicate recommendations to senior leadership.
• Monitor evolving global regulatory requirements, industry trends, and emerging CMC expectations, translating insights into actionable regulatory strategies.
• Provide leadership, mentorship, and subject matter expertise within Regulatory Affairs and across the broader organization.

Qualifications

Required

• 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 and/or CMC-related experience within the pharmaceutical or biotechnology industry.
• Senior Director level: Typically 15+ years of relevant experience, including extensive Regulatory CMC leadership responsibilities.
• Strong knowledge of global CMC regulations, guidelines, and pharmaceutical development requirements.
• Experience supporting both clinical-stage and commercial products.
• Demonstrated success developing and executing regulatory strategies for product registrations and lifecycle management activities.
• 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, negotiation, and stakeholder management skills.
• Ability to influence cross-functional teams and effectively communicate complex technical information to diverse audiences.

Preferred

• Experience supporting small molecule and/or advanced therapeutic products.
• Experience with global regulatory agencies across multiple regions.
• Familiarity with product development from early-stage development through commercialization.
• Prior people leadership and team development experience.
• Experience supporting inspections, compliance activities, and regulatory assessments associated with manufacturing changes.

What You'll Bring

• Strategic thinking with strong business and scientific acumen.
• Ability to balance long-term regulatory strategy with day-to-day execution.
• Collaborative leadership style with a track record of building strong cross-functional partnerships.
• Strong problem-solving skills and the ability to navigate complex regulatory challenges.
• Commitment to quality, compliance, operational excellence, and continuous improvement.

This is a hybrid position requiring regular onsite presence (3x/week) in the Greater Boston Area.