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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 looking 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 the world of 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 and/or indirectly).
* Chair Regulatory Project Team (RPT) meetings with team and affiliates, as applicable.
* Collaborate closely with related product GRLs or pediatric/adult GRL counterparts as necessary.
* Define and execute worldwide RA strategy for the product by providing leadership to advance the product in line with client’s corporate objectives and project team goals.
* Leverage RA experience of regional/in-country RA teams to provide strategic guidance to the Global Development Team (GDT) on innovative approaches, precedents, and risk mitigation.
* Build and maintain partnerships with key stakeholders across RA and cross-functionally.
Key Activities
Strategic activities may include, but are not limited to:
* Provide global regulatory leadership for filings, Health Authority meetings, and internal governance.
* Represent Regulatory Affairs at key cross-functional meetings such as GDT.
* Ensure global strategic alignment and execution across regions.
Experience and Skillset
Position Overview
You will act as the Global Regulatory Liaison on complex or multiple products, compounds, indications, or projects within the therapeutic area. You will manage multiple products or projects simultaneously, defining regulatory strategies, plans, and objectives.
Example Responsibilities
* Contribute to the development and refinement of regulatory strategies, processes, and standards.
* Represent Regulatory Affairs on cross-functional teams, providing strategic advice.
* Define regulatory strategies for multiple products or projects in development.
* Identify and mitigate regulatory risks/issues proactively.
* Oversee and guide regulatory submissions, labeling, packaging, and information updates.
* Review documents for regulatory submissions.
* Provide leadership and management to project teams.
* Ensure compliance with practices, policies, and regulatory requirements.
Requirements
Education & Experience
* PharmD/PhD with 2+ years relevant experience.
* MA/MS/MBA with 8+ years relevant experience.
* BA/BS with 10+ years relevant experience.
* Significant regulatory, quality, or compliance experience in the biopharma industry.
* Proven track record in regulatory strategy and successful product or market approvals.
* Experience negotiating with regulatory authorities.
* Participation in cross-functional projects related to clinical trials or drug development.
* Leadership or matrix management experience.
* Experience with therapeutic areas and post-marketing activities is preferred.
Rest of World Education & Experience
Degree in life sciences or related field with significant regulatory experience in biopharma, regulatory agencies, or clinical research. Experience leading regulatory activities and strategies for biopharmaceutical products.
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