Regulatory Affairs Specialist
Company: Freyr Solutions
- Location: Poland
- Seniority: Mid level
- Employment type: Full-time
- Posted: Yesterday
- Offer language: English
Job description
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 to Warsaw, Poland, we are on the lookout for passionate and skilled Regulatory professionals to join us in shaping the future of regulatory services.
Join Our Team:
If you're ready to embark on a journey of growth and innovation, connect with us to explore the exciting opportunities awaiting you at Freyr's new chapter in Warsaw, Poland. Together, we can shape the future of regulatory solutions.
📢 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!
Position Overview:
The Submission Manager supports the creation, coordination, and execution of content plans across global markets. This role manages all operational aspects from submission planning, document retrieval, document drafting, to content plan creation and overseeing delivery to Health Authorities; while serving as a key liaison between publishing, regulatory affairs, and cross-functional teams in collaboration with other RSM team members. Excellent communication skills are a must to succeed in this position.
Responsibilities:
- Assist in the creation and maintenance of technically compliant regional and global content plans for submissions to US, EU, ACE, and select IC/GPS markets.
- Support submission planning, document retrieval, and content plan creation and delivery from an operational perspective.
- Authoring for select M1 documents such as cover letters and forms.
- Collaborate with GRL/RRLs, Publishing, and cross-functional teams to align timelines, resolve issues, and ensure accurate content planning.
- Populate templates and manage metadata for submission components.
- Track and communicate submission timelines, risks, and delivery status to stakeholders.
- Ensure timely dispatch to Health Authorities and accurate archiving of content plans and dossiers.
Minimum Education and Experience:
- Bachelor's or Master's degree in Life Sciences or a related field.
- 5+ years of relevant experience is preferred in regulatory operations; experience in regulatory affairs is a strong asset.
Veeva Vault or similar submission content planning systems experience.
