Sr. Manager, Regulatory Affairs Cmc (Remote)

The incumbent will play a key role in supporting regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) Small Molecule programs in the pre-approval and/or 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 and his/her own initiative. Play a key role in managing and supporting development of regulatory CMC strategy and various types of submissions, in collaboration with GRA and cross-functional teams such as regulatory leads, CMC writing, submission planning, QA, and technical operations for assigned programs across product life cycle including development and commercialization. In addition, this role will support regulatory compliance activities including but not limited to: change control process and global regulatory assessment, maintenance of internal files for registered regulatory information identified as critical, and support other partner functions (eg, Supply Chain, Quality Assurance) with communications with compliance implication.
The incumbent ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

• Leads and manages the development of 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.
• Works with CMC Writing, Regulatory Operations, and Submission Project management 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.
• 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.
• Remains current on CMC regulatory intelligence including guidelines and compendial requirements.

• Bachelor’s degree in scientific discipline and a minimum of 5-8 years progressively responsible Regulatory Affairs experience in a pharmaceutical or, biotechnology environment (minimum of 3 years in Regulatory CMC). Advanced degree a plus.
• Technical knowledge in small molecules with experience in translating to a regulatory document.
• Demonstrated hands-on experience in pharmaceutical 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.
• Good working knowledge of the FDA, EMEA and ICH regulations and guidance’s for CMC.
• Knowledge of global regulatory guidance’s 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.• 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 and independently, 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%