Senior Manager Regulatory Operations
My client is developing therapies to restore function and improve lives of people with neurological disorders. They are currently seeking a Senior Manager Regulatory Operations to join their collaborative, growing team. With a corporate culture that values hard work, open communication and a commitment to the patients, they have consistently been acknowledged as a top place to work. You will have the ability to work in an environment where you can make an immediate impact and hit the ground running!
Responsibilities:
- Plan submissions to ensure timely submissions to Health Authorities, especially for annual reports, safety alerts and PADERs
- Represent Regulatory Affairs on project teams, driving timelines and deliverables related to submission to Health Authorities
- File regulatory submissions to Health Authorities and archive submissions in accordance with guidelines/SOPs
- Maintain an expert level of knowledge in the eCTD publishing, electronic document management software and relevant regulations for the preparation and maintenance of regulatory dossiers to Health Authorities
Experience:
- Bachelor’s degree or equivalent in Pharmacy, Life Sciences or related field
- Advanced degree (Phd, Pharm D or Master’s degree) in Life Sciences or related field preferred
- Minimum of five to seven years of filing regulatory electronic submissions to health authorities required. Relevant advanced education or experience with regulatory documents may be considered in lieu of some years of electronic submissions
- Experience should include, but not limited to:
- Experience in successfully filing MAA’s, CTA’s to EU Health Authorities, and NDS’s, CTA’s to Canadian Health Authorities strongly