Regulatory Affairs Specialist - Regulatory Project Management
Company: Freyr Solutions
- Location: Poland
- Seniority: Senior
- Employment type: Full-time
- Posted: 4 days ago
- Offer language: English
Job description
About the job
About Freyr
Freyr is a fast-growing, innovative company specializing in providing end-to-end regulatory solutions and services for the Life Sciences industry. With a commitment to excellence and innovation, we assist pharmaceutical, medical device, and biotech companies in navigating the complexities of regulatory compliance.
Why Freyr?
At Freyr, we believe in fostering a collaborative and dynamic work environment that empowers our team to make a real impact. As we expand our footprint , we are on the lookout for passionate and skilled Regulatory professionals to join us in shaping the future of regulatory services.
📢 To Apply:
Please apply to this job post or you can visit our Careers page for more openings
Visit our Careers page at (https://www.freyrsolutions.com/careers/current-positions) to explore current job openings and submit your application.
Don't miss this chance to be a part of Freyr's expansion and make your mark in the world of regulatory services. Let's redefine regulatory excellence together!
Title : Regulatory Affairs Specialist ( Regulatory Submission + Project Management)
Location : Poland / Romania / UK
This role is open for candidates currently located in Poland, Romania and UK only.
Hands-on experience with IND / BLA / NDA Submissions with cross functional team coordination is mandatory for this role.
Description :
Primary Responsibilities:
- Lead regulatory project and submission management activities, coordinating cross-functional teams, timelines, risks, and deliverables to ensure timely and compliant execution of global and local regulatory submissions.
- Coordinate cross-functional teams, including CMC, Labelling, Publishing, local affiliates, etc. to ensure submission readiness and timely delivery.
- Monitor submission progress, dependencies, risks, issues, and action items; proactively escalate deviations and mitigation plans.
- Create/Manage submission content plans, review and approval workflows, RAID logs, and project trackers using client approved tools and systems.
- Coordinate regulatory submission strategy inputs, local regulatory requirements, and documentation readiness with relevant stakeholders.
- Provide regular project status updates, facilitate stakeholder alignment, and ensure compliance with client processes, regulatory guidelines, and submission best practices.
Skills
- Excellent communication and interpersonal skills, Biologics, Cross Functional Project Management, EU FDA RoW Market Regulations, IND/CTA, NDA/BLA/MAA, Stakeholder Management, and negotiation skills, submission management in Veeva
