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Our client develops innovative therapeutic antibodies in immuno-oncology fighting cancer cells by reactivating the body's own defense mechanisms.
For the next possible date we are looking for a Senior Manager regulatory Affairs to step in a permanent position.
Senior Manager Regulatory Affairs (m/w/d)
- Implement regulatory strategy and manage operational activities for assigned products/programs
- Provide input into global regulatory strategy and contribute to Regulatory Strategy Plan (RSP) or equivalent, including identification of gaps or risks, for assigned products/programs
- Drive coordination, planning, and submission of regulatory documentation (e.g. PIND, INDs, Scientific Advice, ODDs, PIPs, MAAs etc.) of assigned products worldwide
- Facilitate timely submission and approval of dossiers with HAs under the guidance of the Sr. Director RA
- On time submission of annual reports and updates for assigned products
- Ensure regulatory compliance for assigned project(s) and keep records of all major HA interactions
- Ensure quality and compliance with global regulatory requirements (in applicable regions) and adherence to regulatory internal policies and processes
- Represent RA on cross-functional teams or sub-teams as required
- Collaborate proactively with all internal and external stakeholders (CRO’s, consultants)
- Prepare and compile the dossier in submission-ready format according to the regulatory requirements of applicable regions by involving external vendors when necessary
- Keep and further develop competence in regulatory affairs and provide training to other staff when needed
Qualifications & Experience:
- University Degree in Natural Science or equivalent education with at least 5 years working experience in Regulatory Affairs in more than one region across the globe
- Post-Doctoral Degree and regulatory competence certifications are a plus
- Very good understanding of the regulatory requirements and guidelines for filings worldwide and critical evaluation of emerging requirements and guidelines for new drugs
- Demonstrating ability to work independently on multiple projects in parallel
- Strong communication and presentation skills
- Excellent team player
- Have a solution-oriented mindset
- Fluent in English (written and oral)
Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.