- Support BLA/MAA/ROW (emerging markets) expansion effort for a biologics project, including compilation of market-specific requirements and leading information request response preparation.
- Track submission activities and change controls for RACMC and ensure visibility to cross-functional CMC stakeholders.
- Assist with ongoing GXP systems transition, related to change control and regulatory dossiers.
- Ad hoc RA CMC support to line manager.
- Assist with post-approval and investigational life cycle management as needed, including but not limited to post approval supplements and variations, annual reports, and investigational (IND/IMPD) amendments, per team and program timelines.
- The outlined tasks may be subject to change as the workload of the business requires.
Required Skills
- Scientific and educational background (BSc or MSc) to understand pharmaceutical drug development concepts, regulatory concepts and create documentation based on these concepts.
- Comprehensive understanding of regulations and guidelines to enhance probability of regulatory success and regulatory compliance.
- Experience in regulatory submissions roles, supporting the compilation of module 3 components of a submission, related Quality/CMC documents and components, and regulatory briefing documents.
- Excellent project management skills.
- Good writing skills for technical writing.
- Detail oriented and highly organized.
- Good verbal communication skills for leading meetings and remote interactions.
- Work well in team setting on a fast-paced business critical project.
- Excellent oral and written communication skills for effectively interfacing with higher levels of management and departments within the company.
This 6+month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.com
ALPHA'S REQUIREMENT #23-01064
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
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