Sr Manager, CMC Regulatory Affairs

The Senior Manager, Global Regulatory Affairs Innovative Medicines CMC Small Molecules (GRAIM CMC SM) ensures regulatory compliance of Chemistry, Manufacturing, and Control (CMC) sections (modules 2.3 and 3) with global and local regulatory requirements throughout the entire lifecycle of the pharmaceutical product How You'll Spend Your Day The responsibilities include 3 Core CMC roles: 1. Development, implementation and coordination of global regulatory CMC strategies 2. Contribution to and/or generation of CMC documentation including compilation and provision in a timely manner 3. Regulatory Intelligence and Training 1. Development, implementation and coordination of global regulatory CMC strategies Lead the development and execution of regulatory CMC strategy to support the innovative small molecule and combination products across both development stage and post-marketing life-cycle management. Serve as the primary RA CMC point of contact, providing regulatory CMC guidance to cross-functional teams, interpretating regulations and advising on their implementation, to support decision-making and ensure regulatory conformity throughout the product lifecycle. Communicate with health authorities focusing on CMC. Prepare and, if needed, participate in meetings with health authorities, including providing relevant CMC documentation. Contribute to the planning and conduct of health authority meetings. Lead the CMC section of the briefing book process. Identify and communicate regulatory CMC risks, conduct appropriate risk analyses, and propose and implement mitigation plan to support product development. Communicate regulatory approval timelines and support project planning. Provide RA CMC evaluation on quality related change controls. 2. Contribution to and/or generation of CMC documentation including compilation and provision in a timely manner Compile, organize, and assess CMC documents for regulatory submissions, and responses to deficiencies during review of submissions, ensuring compliance with the relevant regulatory requirements. It includes Module 3, module 2.3 Quality Overall Summary and any other relevant module documents. Organize, coordinate and oversee the creation, compilation, review, and maintenance of CMC documents for submission. Manage documents timelines and ensure cross-functional alignment on critical-path activities and key deliverables. Maintain oversight of life cycle management for submission documents to ensure consistency, traceability and ongoing compliance. 3. Regulatory intelligence and training Continuously learn the latest regulatory guidelines, industry standards, and best practices to ensure ongoing compliance and effective regulatory strategies. Provide training to internal stakeholders where necessary. Engage in influencing the global regulatory landscape. Contribute to calls for comments by reviewing and providing input on draft guidelines, position papers, and other consultation documents made available by regulatory authorities Your Skills and Experience - Bachelors degree in a scientific discipline - At least 5 years of experience in the pharmaceutical industry Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered. Also Good to Have - 5 years of Regulatory Affairs experience and 2 years management experience - Relevant technical experience in Analytical (QC, Analytical R&D), process/product development, or manufacturing - Knowledge of FDA and ICH Regulatory guidelines - Experience with eCTD regulatory filings - Knowledge of U.S. and global content and regional requirements How We'll Take Care of You We offer a competitive benefits package, including: - Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls. - Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan. - Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays. - Life and Disability Protection: Company paid Life and Disability insurance. - Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more. The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. Make sure to apply through our internal career site on Twist-your one-stop shop for career development