NewAmsterdam is an innovative biotech company with the experience and expertise to deliver across its ambitious clinical, regulatory, and commercial goals. Our robust scientific approach focuses on advancing a new era of life-saving treatments for lipid-related diseases. Our vision is that people at risk for heart disease can take control of their health and live longer, fuller lives. Our team is led by a world-class team of industry veterans and key opinion leaders, including some of the world's preeminent cardiometabolic experts and we foster a passionate, supportive culture that is backed by a high level of integrity and inclusivity.
NewAmsterdam Pharma (NAP) is seeking a Director, CMC Regulatory, to manage CMC Regulatory oversight and drive CMC sections of regulatory submissions during all phases of Clinical and Commercial products. Primary responsibilities will be to ensure regulatory submissions (such as IND, IMPD, NDA, and MAAs) are accurate, supported by source records, and meet expected execution timelines. This position is expected to be a driver of CMC regulatory project. This is a remote position with team building and conference travel expected, and will report to the SVP, Quality and CMC Regulatory Affairs.
Key Responsibilities:
Develop and implement regulatory strategies for drug development programs, ensuring alignment with business objectives.
Lead the preparation, submission, and maintenance of CMC related regulatory filings and sections (examples but not limited to IND, IMPD, CTA, MAA, NDA). This includes project management of tasks and deliverables.
CMC submission content plan (Module 2.3, 3, and CMC specific Module 1 documents) for marketing applications.
Compile and review regulatory documents, ensuring scientific integrity and compliance.
Understand, communicate, and provide Global strategic solution approach to managing regional differences
Responsible for submission ready documents for publishing
Key partner to interact with the CRO regulatory vendor to ensure deliverables are properly planned and CMC content is delivered in a timely manner
Provide strategic regulatory guidance to internal stakeholders and subject matter experts on drug development, CMC, and labelling requirements.
Facilitate meetings with SMEs for document review and comment resolution to regulatory submission documents.
Lead the development and implementation of a change control system that meets the requirements to assess, track, and and file regulatory changes to support life cycle management of NAP's products.
Responsible for CMC related communication and interactions with the FDA and other health authorities.
Identify key risks relating to CMC strategy and offer solutions/guidance to SMEs for regulatory agency meetings, in all applicable regions from pre-submission for through commercialization for products at all stages of development, ensuring optimal communication and negotiation.
Collaborate with clinical, CMC, and quality teams to proactively identify and address regulatory challenges and expedite drug development timelines.
Stay up to date with evolving regulatory requirements and ensure company practices remain compliant with FDA, EMA, and ICH guidelines.
Responsible for reviewing and documenting issues/events, assessing product quality and program regulatory impact. Partner with internal and external stakeholders to drive issue resolution, change control, deviation/CAPA identification and ensure timely closure.
Provide CMC related content for safety reports and annual reports.
Provide leadership and mentorship to team members.
QMS Responsibilities
Develop, review and approve GxP regulatory related controlled documents, such as: Policies, Standard Operating Procedures (SOPs), Work Instructions, and supporting documents related to GxP activities.
Perform applicable Trainings such as inspection readiness.
Assist with preparation of Health Authority inspections and necessary responses, as applicable.
Work closely with Quality and CMC on recall preparation and if needed perform Recall and Field Alert activities.
Requirements:
Bachelor's degree in a scientific discipline, Chemistry and advanced degree preferred
15+ years in the pharmaceutical industry, with a minimum of 8 years in Regulatory. Quality Manufacturing background is a plus but not required.
Proven track record of leading regulatory submissions including INDs, IMPDs, NDAs, and MAAs.
Rest of World regulatory experience including Japan and China is preferred.
Deep knowledge of FDA regulations, ICH guidelines, and global regulatory pathways for drug development as well as change control and reporting post approved product.
Solid understanding of GxP standards, policies, and procedures (domestic and international)
Experience and understanding of small molecule drug substance and non-sterile solid oral dosage drug product.
Experience with managing vendors.
Excellent verbal and written communication skills
Collaborative problem-solver, with a proven track record to analyze complex issues to develop relevant and realistic plans, programs, and recommendations
Ability to continuously re-prioritize and work independently, as a member of a cross-functional team, and with external vendors with minimal supervision
Ability to travel domestically and internationally, approx. 10% of the time
Remote position, US Eastern work hours expected.
Salary and Benefits: We offer a competitive base salary, commensurate with experience. In addition to the salary, we provide a comprehensive benefits package, including health insurance, dental and vision coverage, term life and disability coverage, retirement plans, and stock option awards.
NewAmsterdam Pharma is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information, or any other basis protected by federal, state or local law.