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Senior Manager, Regulatory Affairs CMC
2 months ago
Job Description Summary:
The Senior Manager, Regulatory Affairs - CMC will play a key role in supporting regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs in both the pre-approval and post-approval space globally, as assigned. This position works cross-functionally and serves as a liaison between the Regulatory Affairs team and other PTC departments under supervision of the Regulatory Affairs - CMC management. Play a key role to lead or support RA CMC projects with coordination of RA CMC projects, organizing and managing logistics for strategy discussions, and cross-functional coordination with other teams such as scientific/CMC writing, submission planning, QA, and technical operations for assigned programs across product life cycle including development and commercialization.
The Senior Manager, Regulatory Affairs - CMC ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. Job Description:
Responsibilities:
Develop Module 2 and 3 CMC documents for regulatory filings such as INDs/IMPDs/CTAs and MAAs/NDAs/ global registrations and eCTD submissions, ensuring that they meet current regulatory standards and are high quality, clear, consistent, and complete.
Establish product specific strategies to ensure successful development of CMC packages to support development, registration and life cycle management including variations, annual reports, supplements, renewals and responses to questions from health authorities.
Ensuring compliance with current ICH and global regulatory requirements.
Establish alignment with PTC regulatory strategies and to communicate regulatory CMC requirements to team members both internally and externally.
Interact with Technical Operations and Quality groups consistently to ensure regulatory impact is assessed on CMC related issues.
Review and approve CMC change control documents.
Participate in relevant standard operating procedure preparation and working instructions
Effectively communicate comments/recommendations and proactively engage teams to establish solutions to issues and ability to influence outcomes as applicable.
Qualifications:
Bachelor's degree in scientific discipline and a minimum of 5-7 years progressively responsible Regulatory Affairs experience in a pharmaceutical or biotechnology environment (minimum of 3 years in Regulatory CMC). Advanced degree a plus.
Prior experience within a GMP environment with a firm understanding of industry regulations and best practices.
Good working knowledge of the FDA, EMEA and ICH regulations and guidance's for CMC.
Knowledge of global regulatory guidance as it relates 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.
Thorough knowledge of the drug development process, with a focus on the regulatory CMC processes.
Demonstrated experience in preparing IND and/or NDA submissions.
Proficiency with Microsoft Office.
Excellent verbal and written communication skills.
Ability to work collaboratively under supervision, 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.
Results driven and keen attention to details.
Travel requirements: Up to 10% travel
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.
