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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.
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. Together, we can shape the future of regulatory solutions.
? To Apply:
Please apply to this job post or 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 part of Freyr's expansion and make your mark in regulatory services. Let's redefine regulatory excellence together!
Title: Global Regulatory Lead / Associate Director - Regulatory Affairs
Location: Remote (Base location should be in UK/EU, preferably in Hungary, Poland, Romania, Czech Republic, or Croatia)
Experience: Minimum 8 years of direct experience with Medicinal Product Regulatory Affairs
Role Summary:
* Serve as a global regulatory liaison (GRL) for select products.
* Lead a global team of regulatory professionals covering the product, directly or indirectly.
* Chair Regulatory Project Team (RPT) meetings with team and affiliates.
* Collaborate closely with related product GRLs or pediatric/adult GRL counterparts.
* Define and execute worldwide RA strategy for the product, providing leadership aligned with client’s objectives.
* Leverage regional RA teams’ experience to guide global development strategies, mitigate risks, and explore innovative approaches.
* Build and maintain partnerships across RA and cross-functional teams.
Key Activities:
Strategic activities include:
* Providing global regulatory leadership for filings, health authority meetings, and internal governance.
* Representing Regulatory Affairs at key cross-functional meetings like GDT.
* Ensuring strategic alignment and execution across regions.
Experience and Skillset:
Position Overview:
Act as the global regulatory liaison for complex products or projects, defining strategies and managing multiple initiatives simultaneously.
Responsibilities:
* Contribute to development and refinement of regulatory strategies and practices.
* Represent Regulatory Affairs in cross-regional teams and provide strategic guidance.
* Define regulatory strategies for multiple products/projects in development.
* Identify risks and develop mitigation plans.
* Oversee regulatory submissions, labeling, and documentation updates.
* Review documents for regulatory approval.
* Provide leadership to project teams and ensure compliance with policies and regulations.
Requirements:
* PharmD/PhD with 2+ years' relevant experience; MA/MS/MBA with 8+ years; BA/BS with 10+ years.
* Significant regulatory, quality, or compliance experience in biopharma.
* Proven track record in regulatory strategy and negotiations with authorities.
* Experience in clinical trials and drug development activities.
* Leadership experience, including managing teams or matrix management.
* Experience in therapeutic areas and post-marketing activities preferred.
Rest of World Experience:
Degree in life sciences or related field with significant regulatory experience in biopharma, agencies, or healthcare environments. Leadership in regulatory activities and strategy setting for biopharmaceuticals.
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