Director, Regulatory CMC

Director, Regulatory CMC

Rhythm Pharmaceuticals

Amsterdam, Netherlands

Opportunity Overview

This key role will be responsible for ensuring the development and delivery of science-based, solution-oriented, and internally aligned regulatory CMC strategies for the program(s) under his/her accountability.

Reporting to the ED International Regulatory Affairs you will lead the Regulatory CMC strategy and initiatives for your assigned programs. By joining our growing and dynamic regulatory affairs team, you will be responsible for the effective management and timely delivery of CMC regulatory documents, while maintaining compliance with global regulatory standards and commitments. You will provide technical and procedural regulatory CMC guidance and strategy to key internal stakeholders to advance the development, commercialization, and life cycle of Rhythm products and help improve internal standards and systems.

Responsibilities and Duties

• Act as the primary regulatory CMC representative on multi-disciplinary teams and provide strategic regulatory CMC guidance through the product life cycle (e.g., integrated CMC regulatory strategies and implementation plans);
• Create high quality, compliant CMC regulatory documents (e.g., Core Dossiers, INDs, IMPDs, MAAs, BLA, variations, annual reports) in close collaboration with internal and external stakeholders and coordinate responses to health authority questions within defined timelines;
• Ensure effective and timely execution of regulatory filings in compliance with relevant regulatory standards and commitments;
• Prepare meeting requests and briefing documents; ensure team is ready for meetings and teleconferences with Regulatory Agencies;
• May serve as the liaison between the company and Regulatory Agencies for assigned project;
• Perform assessment of CMC change controls, identifying global regulatory requirements, and evaluating supporting documentation to verify acceptability and identify potential risks;
• Maintain up-to-date knowledge of relevant CMC-related guidelines in key geographies and effectively communicate across the organization any impact on development programs in a timely manner;
• Assist in the development and maintenance of departmental processes, policies, SOPs and associated documents;
• Participate in initiatives aimed at improving internal standards and systems.

Qualifications and Skills

• A minimum of B.S. degree in a scientific or life sciences discipline with a minimum of 10+ years’ experience in the areas of Regulatory CMC, manufacturing, analytical development and quality environment for pharmaceutical products;
• Demonstrated experience with regulatory programs for products to treat rare diseases and/or high unmet medical needs (e.g., orphan products, fast track, breakthrough therapies, PRIME);
• Prior experience in small molecule and oral drug formulation development and product registration activities within the pharmaceutical or biotech industry is required;
• Experience with peptides and injectable dosage forms and/or with injection drug delivery devices is preferable;
• Evidence of being a critical strategic thinker, pro-actively minded, who is solution oriented with the ability to think outside of the box; preference for demonstration of such within rare disease programs;
• Full functional knowledge of integrated CMC regulatory requirements (regulations, directives, and guidances/guidelines) pertaining to the development, registration, and life cycle management of drug products and medical devices in multiple ICH regions;
• Ability to set priorities, work independently, and deliver results in a timely manner and ability to adapt and react to new information or changing priorities;
• Strong organizational and planning skills, and ability to communicate effectively and efficiently to multiple stakeholders within the organization and with external partners.