Quality/Risk Management, Research & Development, US Regulatory Affairs, Worldwide Regulatory Affairs
4 Year Degree
The Director, Regulatory Affairs – CMC (Drugs) is responsible for providing regulatory leadership in Chemistry, Manufacturing and Control (CMC) for PTC’s pharmaceutical products, including: leading the CMC regulatory strategy development and implementation that incorporates risk identification and mitigation for programs at various stages of product life cycle; direct and manage regulatory CMC activities and dossier content for global health authorities within timelines and in accordance with global regulatory expectations and requirements.
This position works cross-functionally and serves as a liaison between the Regulatory Affairs team, other PTC teams and departments (including Technical Operations and Quality), external business partners and contractors. S/he also plays a key role in developing organizational capabilities for the regulatory department and RA CMC group.
The Director, Regulatory Affairs - CMC ensures for adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Provides effective Regulatory CMC leadership and representation for clinical and commercial stage pharmaceutical products and acts as a key player in interactions with regulatory agencies on CMC related topics, in collaboration of the global regulatory teams.
Effectively interprets and applies regulatory guidance and provides regulatory recommendations and solutions to key stakeholders.
Drives alignment building of regulatory CMC strategy within RA department and other functions. Effectively communicate regulatory strategy in a cohesive RA voice to the stakeholders.
Actively collaborates with development teams, Technical Operations (Development, Manufacturing, Supply Chain), and Quality to develop and execute robust regulatory strategies and risk mitigation for product development, registration, and post-marketing life cycle management.
Leads and manages the development and preparation of CMC-related submission documents and ensures they meet current regulatory standards and are of high quality, to enable regulatory approval on the first review cycle. The submissions include, but not limited to, new drug marketing applications (eg NDA, MAA, NDS, etc), electronic Common Technical Documents (eCTDs), investigational new drug applications (eg INDs, CTAs), briefing documents, response to queries, Orphan Drug Applications, and annual reports.
Manages regulatory CMC activities for product global expansion, in close collaboration with Regulatory International colleagues. Establishes best practice in developing and maintaining global CMC core dossier for each marketed product.
Leads and establishes best practice for regulatory CMC compliance activities including, but not limited to, change controls, post-marketing commitments, product complaints, and regulatory inspections.
Manages direct report(s) and provides mentorship for their performance and professional growth;
Partner with RA CMC team members to drive capability building including best practices, cross product learning, operational excellence, and resource utilization.
Remains current on CMC regulatory intelligence including guidelines, compendial requirements, and regulatory trends.
Minimum level of education and years of relevant work experience.
Bachelor’s degree in a scientific discipline. A minimum of 8 years progressively responsible Regulatory Affairs experience in a pharmaceutical, biotechnology or related environment (including a minimum of 5 years in Regulatory CMC role(s)).
Special knowledge or skills needed and/or licenses or certificates required.
Demonstrated, hands-on experience in drug development, registration, and post-approval life cycle management in a global environment.
Prior experience within a GMP environment with a firm understanding of industry regulations and best practices
Excellent working knowledge of the ICH region regulations for drugs.
Knowledge of global regulatory guidances as they relate to the overall global regulatory strategy.
Ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
Demonstrated experience in preparing regulatory submissions, including IND/CTA, NDA/MAA, briefing documents, and response to agency queries.
Ability to influence without direct authority.
Demonstrated excellent collaboration skills.
People management (direct or indirect) experience.
Excellent verbal and written communication and skills.
Ability to work independently and collaboratively in a fast-paced, matrixed, team environment consisting of internal and external team members.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
Proficiency with Microsoft Office.
Special knowledge or skills and/or licenses or certificates preferred.
Advance academic degree (Masters or PhD).
Regulatory experience in non-CMC related matters.
Regulatory experience in supporting development and registration in ex-ICH regions
Telecommuting is allowed.
Additional Salary Information: tbd
Internal Number: R221
PTC is a science-led, patient-centered biopharmaceutical company focused on discovering, developing and commercializing medicine for patients with rare disease.