[01/06/2025] Global Regulatory Lead...

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. Join Our Team: If
youre 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 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. Dont miss
this chance to be a part of Freyrs expansion and make your mark in
the world of regulatory services. Lets 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/ Croatia) Experience : Min 8 years of direct experience with
Medicinal Product Regulatory Affairs Development Global Regulatory
Liaison Role Summary - Serve as a global regulatory liaison (GRL)
for select products. - Leads a Global team of regulatory
professionals covering the Product (indirectly and/or directly) -
Chairs Regulatory Project Team (RPT) meetings, with team, and
affiliates, as applicable. - Collaborates closely with either
related product GRLs, or pediatric/adult GRL counterpart, as
necessary. - Accountable for the definition and execution of
worldwide RA strategy for Product by: - Providing leadership to
advance the Product in-line with Client’s Corporate Objectives/
Project Team Goals - Leverage RA experience of wider
regional/in-country RA teams to provide technical and strategic
guidance to Global Development Team (GDT) on innovative approaches,
precedents, and possible risk mitigations of product. - Build,
maintain, and advance partnerships with key stakeholders across RA,
and cross-functionally. Key Activities Strategic activities
associated with this role may include, but is not limited to: -
Provide global regulatory leadership for key activities such as,
global filings, Health Authority meetings, and internal governance
product strategy - RA Representation at key cross-functional
meetings such as Global Development Team (GDT) - Ensure global
strategic alignment and execution across regions Experience and
Skillset POSITION OVERVIEW You will act as the Global Regulatory
Liaison on more complex or multiple products, compounds,
indications or projects in the assigned therapeutic area. You will
typically be assigned multiple products or projects to lead, manage
and oversee simultaneously. You will define the regulatory
strategy, plans and objectives for assigned products or projects.
EXAMPLE RESPONSIBILITIES - Makes significant contributions to the
ongoing development and refinement of regulatory strategies,
processes, standards, practices, efficiencies and capabilities. -
Represents Regulatory Affairs on cross-functional/cross-regional
Regulatory Submission Teams. Provides strategic advice and guidance
to Regulatory Affairs and cross-functional leaders and teams. -
Defines the regulatory strategy for multiple Client’s products or
projects in the development phase. - Proactively identifies
regulatory or related risks/issues and develops mitigation and/or
contingency plan. - Oversees and guides the preparation,
compilation, and timely filing of regulatory submissions, which
require cross-functional interactions for investigational or
marketed product(s). - Oversees and guides labeling, packaging and
associated information updates and maintenance in accordance with
the product license for assigned products and markets. - Critically
reviews documents for submission to regulatory authorities. -
Provides matrix management and leadership to project teams. -
Ensures own work complies with established practices, policies and
processes, and any regulatory or other 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, compliance or related experience in the biopharma
industry. - Proven track record in effectively setting and
directing the regulatory or related strategy to successful
conclusion for one or more products or key markets. - Experience
and proven effectiveness working and negotiating with regulatory
authorities. - Significant experience participating in
cross-functional projects and teams with responsibilities related
to clinical trials or other drug development activities. -
Demonstrated abilities to effectively delegate and manage others,
as evidenced through either past people management or matrix
management responsibilities. - Experience working with one or more
Client’s therapeutic areas and postmarketing phase strongly
preferred. Rest of World Education & Experience BA/ BS or
advanced degree in life sciences or related field with significant
regulatory experience in the biopharma industry, regulatory agency,
clinical research or other related healthcare environment.
Experience leading a broad range of regulatory activities and
setting the regulatory strategy for biopharmaceutical
products.