Director of Regulatory CMC
About this role
At Indegene, we are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy.
To lead, build CMC expertise, and oversee a growing CMC writing team within our Regulatory Services business. This leader will be responsible for both internal team management and client-facing strategic CMC consulting. The ideal candidate brings hands-on CMC expertise, including preparation of CMC documentation, as well as confidence, poise, and the ability to lead client engagements. This role will also help shape best practices for CMC content generated via our AI platform, collaborating closely with clients and internal teams as we advance our CMC capabilities.
Responsibilities:
- Leadership and Team Building: Lead, mentor, and expand a global team of CMC medical writers/experts. Establish team structure, processes, and operational standards for a newly built CMC capability. Contribute to the development of CMC operating models, processes, and procedural documentation.
• Client-Facing Responsibilities: Represent the CMC team as a senior subject matter expert in meetings with clients, including regulatory strategy discussions and project scoping. Provide expert input into solutions, assumptions, demand estimates, and costing for client proposals. Participate in/lead pitch meetings.
• CMC Operations/Writing & Quality Oversight: Oversee quality for CMC deliverables prepared by the writing team. Ensure quality, timelines, and compliance with performance metrics and contractual specifications. Contribute hands-on writing or review as needed, particularly for high priority clients or complex CMC documents.
• Supporting AI development: Serve as the strategic advisor on AI-generated CMC outputs from the AI platform. Drive development of the CMC outputs by generating and reviewing CMC outputs from our medical writing platform and working with the AI development team to improve the quality of the outputs.
• Cross-functional Leadership and Collaboration: Work with Regulatory Strategy, Operations, Manufacturing, Go to Market team, and AI platform teams to ensure unified delivery across projects. Coordinate closely with the Regulatory leadership team to further expand the team and the business.
Knowledge and Skill Requirement:
- Extensive experience in CMC operations, writing, and a strong familiarity with regulatory expectations across development stages (new products as well as life-cycle management of marketed products).
• Proven leadership experience, preferably at the Manager, Senior Manager, or equivalent level, within pharmaceutical or biotech organizations.
• Demonstrated experience presenting scientific data to internal leadership and/or external partners.
• Ability to operate confidently as a consultant-level subject matter expert and interact directly with clients.
• Track record of managing or collaborating with manufacturing sites, QC/QA teams, CROs and other cross-functional stakeholders.
• Strong communication skills and comfort with both strategic and operational aspects of CMC projects.
• Strong business acumen and financial understanding of various business models.
Good to have:
- Experience shaping or evaluating AI-assisted document workflows and outputs.
• Knowledge of building new service lines or operational structures within regulatory writing.
• Ability to work in fast-paced, ambiguous, or start-up-like environments while shaping new capabilities.
• Experience working with international team members.
Experience: 20+ years of overall experience in CMC operations, writing, and a strong familiarity with regulatory expectations across development stages (new products as well as life-cycle management of marketed products).
Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, the candidate’s merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.
Originally posted on Himalayas