Senior Regulatory Associate - CTA
Proclinical has partnered with a global pharmaceutical organisation in search for a Regulatory Affairs Senior Associate. The Regulatory Affairs Senior Associate under the direction of a Regional Regulatory Lead will assist in the creation and submission of regulatory documents for one or more assigned projects.
- Assist Regional Regulatory Lead to support regional regulatory filing activities (e.g. core CTA/IMPD development and submission)
- Provide and maintain CTA/MA documentation (e.g. variations, substantial amendments, PDCO annual reports) in collaboration with Regional Regulatory Lead
- Coordinate collection of functional documents in support of regulatory applications
- Prepare regulatory packages and cross-reference letters to support investigator sponsored studies
- Actively support regulatory compliance, and ensure compliance via timely submissions to regulatory agencies
- Create and maintain product regulatory history documents through company systems and appropriately archive all regulatory documents and agency communications
- As appropriate may participate in GRT to support execution of regulatory strategy
- Respond to specific requests from and communicate relevant issues to GRT
- Support the development and execution of GRT goals
- Review regional component of the Global Regulatory Plan and provide input to operational deliverables
- May support RRL in review of promotional materials for commercial activities
- Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area teams
- Support process improvement initiatives, standards development, and metrics
Skills and Requirements
- Graduate in a life science subject as a minimum, post graduate degree desirable
- Minimum 5+ years' proven experience in an appropriate regulatory role, with experience in Advanced Therapy Medicinal Products preferred
- Experience in implementing and helping to develop regulatory strategies for Advanced Therapy Medicinal Products including orphan indications
- Keeps up to date with professional knowledge, expertise and best practice.
- Excellent oral and written communication skills.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.