Director, Regulatory Affairs - CMC

PTC Therapeutics•Warren, MI

About The Position

The Director, Regulatory Affairs – CMC is responsible for leading global regulatory CMC strategy for product development, registration, and post-approval life cycle management of primarily biological products. The Director leads and manages preparation of CMC dossier for regulatory submissions of the various stages (eg INDs/IMPDs, BLAs/MAAs) according to global regulatory expectations and requirements. This position works cross-functionally with Regulatory Affairs, Technical Operations, Quality, and program teams to facilitate the completion of regulatory submissions through regulatory approvals in accordance with company goals and timelines. This position ensures adherence to relevant regulatory requirements and guidelines, and company Standard Operating Procedures (SOPs) as appropriate.

Requirements

Bachelor’s degree in a scientific discipline.
A minimum of 8-10 years of experience in Regulatory Affairs CMC strategy and submissions in a biotechnology, pharmaceutical, or related environment with innovative drug development and/or commercialization.
Experience in biologics is a must; experience in gene/cell advanced therapy a plus.
Technical knowledge in biologics with experience in translating to a regulatory document
Demonstrated, hands-on experience in pharmaceutical development, registration, and/or 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 guidelines and regulations
Knowledge of global regulatory guidelines and expectations 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, BLA/NDA/MAA, NDS, briefing documents, and response to agency queries.
Ability to influence without direct authority.
Demonstrated excellent collaboration skills.
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.

Nice To Haves

Advance academic degree (Masters or PhD) a plus.
Regulatory experience in non-CMC related matters.
Regulatory experience in supporting development and registration in ex-ICH regions

Responsibilities

Leads development of robust global regulatory CMC strategy and risk management to enable successful regulatory submissions and approvals for drug development and registration.
Provide regulatory CMC guidance effectively to the cross functional teams, with a phase-appropriate, risk-balanced, and pragmatic approach.
Leads and manages the development and preparation of CMC-related submission documents for primarily biological products (eg, gene therapy) in collaboration with Technical Operations, Quality, and Regulatory Affairs to ensure they are organized, logical, in accordance to 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 BLA/NDA, MAA, NDS, etc), investigational new drug applications (eg INDs, CTAs), briefing documents, response to regulatory authority queries, Orphan Drug Applications, etc.
Manages regulatory agency interactions as related to CMC.
Effectively interprets and applies regulatory guidance.
Provides regulatory guidance, recommendations and solutions to cross functional teams and key stakeholders.
Works with GRA functions to support development of internal processes to improve the CMC aspects in regulatory documents, including the writing, review and approval process, critical review and reconciliation of team comments, and ensuring documents are of high-quality.
Supports best practice for regulatory CMC compliance activities including, but not limited to, change controls, post-marketing commitments, product complaints, and regulatory inspections.
Remains current on CMC regulatory intelligence including guidelines and compendial requirements