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Job Description Summary:

The Senior Director, Regulatory Affairs CMC, is responsible for providing strategic leadership and oversight in regulatory Chemistry, Manufacturing and Control (CMC) for primarily PTC pharmaceutical/small molecule development products. This involves but not limited to: leading development and implementation of robust global regulatory CMC strategy that is phase appropriate and risk balanced; leading and overseeing development and implementation of global regulatory strategy for PTC products that involve medical device components or deem to be combination products; leading and overseeing submission teams in preparation of regulatory CMC content for clinical trial applications and marketing applications to global health authorities; providing leadership and support to regulatory agency interactions as pertaining to CMC topics. The Senior Director is also responsible for overseeing RA CMC Compliance activities including but not limited to: change controls, periodic regulatory reporting (eg, annual reports, DSUR/PSUR), and initiatives in enhancing good practices.

This position serves as an active representative of PTC in regulatory and/or industry forums where s/he provides PTC input and develops influence in quality guidelines and practices. Reporting to the VP/Head of RA CMC, the Senior Director contributes to and supports RA CMC organizational capability development, resource planning, and project prioritization. The Senior Director works in a cross functional and collaborative environment, and serves as a partner and liaison between the Regulatory Affairs team, other PTC teams (including Program Teams, Technical Operations, and Quality), and external parties (including applicable contract manufacturers, industry regulatory organizations and forums).

The Senior Director ensures adherence to relevant regulatory requirements and expectations, and company policies and Standard Operating Procedures (SOPs) as appropriate.Job Description:

Responsibilities:

• Provides effective Regulatory CMC leadership and representation for preclinical, clinical and registration stage programs for pharmaceutical/small molecule products.
• Actively collaborates with Global Regulatory Teams, Program Teams, Technical Operations, and Quality Assurance to lead and oversee development and execution of robust global regulatory CMC strategies and risk management for PTC pharmaceutical/small molecule programs during product development, commercialization, and post-approval product life cycle management.
• Acts as a key player in interactions with regulatory agencies (eg, FDA, EMA, ANVISA, PMDA, Health Canada, etc) as related to CMC topics. Leads, manages, and/or participates in regulatory CMC-related health authority meetings and preparation of meeting packages.
• Establishes alignment in global regulatory CMC strategies and communicates regulatory requirements and recommendations to team members both internally and externally.
• Leads and oversees regulatory CMC support to the relevant manufacturing and testing activities through drug development and registration. Provide oversight to regulatory agency inspections pertaining to drug development and registration.
• Leads, oversees, and influences consistent strategy and approaches in CMC development, registration, and life cycle management strategy at PTC in collaboration with cross functional teams. Establish collaborations with CMC and Quality stakeholders.
• Leads and oversees development and preparation of CMC-related documents and ensures they meet current regulatory standards, are of high quality, consistent, and complete to enable approvability in the first review cycle. This includes, but may not be limited to, marketing applications (NDA/MAA), clinical trial applications (IND/CTA), CMC supplements/amendments, global core CMC dossier, agency meeting briefing documents, and pediatric investigational plans (PIP).
• Performs critical and thorough reviews on regulatory submissions that contain CMC relevant information. Provides constructive input and suggestions to drive for high quality dossier.
• Performs critical and thorough reviews and provides regulatory input to applicable technical documents provided by the CMC and Quality functions, ensures conformance with applicable regulations and regulatory guidelines. Advises on the relevant information adequately for regulatory submissions.
• Oversees regulatory CMC compliance activities, not limited to, regulatory annual reporting, regulatory assessment for change controls and deviations, and regulatory inspections/audits.
• Works with VP RA CMC to manage RA CMC team capability development, resource planning, project prioritization, and collaboration projects with other functions. Contributes to capability building for regulatory CMC best practices and knowledge sharing within PTC.
• Recruits, develops, and retains direct report(s). Leads development and sustainable growth of the team. Mentors junior RA CMC staff members.
• Remains current on CMC regulatory intelligence, global regulatory requirements and guidelines, and pharmacopoeia changes. Effectively interprets regulatory guidance and provides recommendations to key stakeholders.

Qualifications:

• Bachelor's degree in a scientific discipline and a minimum of 12+ years of Regulatory Affairs experience with progressive leadership responsibilities in a pharmaceutical, biotechnology or related environment (including a minimum of 7 years in Regulatory CMC role).
• A minimum of 5 years managerial experience in a matrixed organization

* Special knowledge or skills needed and/or licenses or certificates required.

• Demonstrated hands-on experience in innovative drug development and registration.
• Demonstrated experience in managing clinical trial applications (IND/CTA), marketing applications (BLA/MAA) globally, agency meeting briefing documents, etc.
• Prior experience within a GMP environment with a firm understanding of regulations and industry best practices.
• Excellent working knowledge of the US, EMEA, and ICH regulations and guidelines for human investigational and/or medicinal products.
• Ability to understand and interpret complex scientific issues across multiple projects as they relate to regulatory requirements and strategy.
• Ability to influence without direct authority.
• Proficiency with Microsoft Office.
• Excellent verbal and written communication 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.

*Special knowledge or skills and/or licenses or certificates preferred.

• Advance academic degree (Masters or Doctorate).
• Knowledge and direct experience in drug-device combination products and/or medical devices
• Regulatory experience and knowledge in non-CMC related regulatory matters.
• Rare Disease

Travel requirements: 10% travel to PTC NJ or other sites for face-to-face interactions, as needed.

EEO Statement:

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PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, p regnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.