The Contract - CMC Regulatory Technical Writer has responsibility for authoring CMC sections for biologics regulatory submissions according to PTC regulatory and technical strategies and global regulatory requirements
This position works cross-functionally with Regulatory Affairs CMC, Technical Operations, and Quality to ensure high-quality and accurate CMC content in regulatory filing submissions.
The CMC Regulatory Technical Writer ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
The CMC Regulatory Technical Writer is responsible for authoring and managing the content, development and preparation of CMC-related submission documents for assigned projects at the direction of Regulatory CMC and in collaboration with Technical Operations, and Quality to ensure content is organized, accurate, logical, and complete.
Establishes alignment of authoring and content with PTC regulatory and technical strategies.
Translates product specific strategies to regulatory documents to ensure successful development of CMC packages to support early development, registration and life cycle management.
Effectively communicates comments/recommendations and proactively engage teams to establish solutions to issues.
Develops timeline for responding to CMC related inquiries from global regulatory agencies to ensure issues are addressed in a timely manner
Special knowledge or skills needed and/or licenses or certificates required.
Technical knowledge in cell and gene therapies with experience in translating content 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.
Excellent working knowledge of the ICH region regulations for drugs and biologics.
Knowledge of global regulatory guidance 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/MAA, briefing documents, and response to agency queries.
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.
* Travel requirements
Up to 10%
*Physical requirements (only note if the job requires physical capacity beyond general office work)
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, pregnancy, 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.