Regional Regulatory Lead (Reading)

Not for Candidates located in India.We are looking for someone who can start immediately

Applications from locations other than UK / EU Countries will not be considered

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 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 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:Regional 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

Role Summary

• Serve as a regional regulatory lead (RRL) in the EU and be the point of contact for the local health authority (EMA) for select products.
• Accountable for the definition and execution of regional RA strategy for assigned products) which includes, but is not limited to:
• Provide knowledge and input to Global Regulatory Lead (GRL) to advance the product in-line with Corporate Objectives/Established Products Project Team (EPT) Goals
• Ensure fulfilment of regional regulatory commitments, in addition to supporting the regulatory submission activities.
• Leverage RA experience of wider regional/in-country affiliate RA teams to provide technical and strategic guidance to GRL on innovative approaches, precedents, and possible risk mitigations of product.
• Represent the regulatory department and actively participate at cross functional teams.
• To act as the subject matter expert (SME) and provide valid regulatory guidance to support ongoing regulatory activities (EU)
• Build and maintain strong relationships with cross-functional teams.
• Build, maintain, and advance partnerships with key stakeholders across RA (including affiliates/distributor group).
• Act as a delegate for GRL, as appropriate Key activities

Key Activities:

Strategic activities associated with this role may include, but is not limited to:

• Ensuring Maintenance of regional investigational and marketing applications (MAAs, CTAs, /BLA/Orphan applications) in alignment with local regulations
• Participation in preparation/lead preparation and submission of routine aggregate reports such as PSUR/PBRER/DSUR/PADER/ Annual Report
• Participation/regional leadership for sunsets and/or divestments
• Lead local license withdrawal/renewal activities
• Representation at cross-functional meetings - Study Management Team (SMT), Established Products Project Team (EPT) (as needed)
• Regulatory Intelligence related to program needs e.g. research on precedence, impactful guidance documents, competitor intelligence, new/amended regulations process Improvement Initiatives

Experience & skillset

Position Overview for Established Products

You will typically act as the Regional Regulatory liaison for the assigned products, compounds, indications or projects in the assigned therapeutic area. With guidance, you will define the regulatory strategy, plans and objectives for the assigned products or projects. You will typically lead the Regulatory Submissions Teams associated with assigned products or projects and represent Global TA Regulatory to cross-functional sub-teams. You may serve as a contact to / for regulatory authorities. You will oversee and manage the work of less experienced colleagues supporting your work. You will coach and advise less experienced colleagues in completing their work and developing their regulatory capabilities. You will typically be assigned products, compounds, indications or projects of increasing complexity. You will also typically play a more active role in process improvements and other special projects that can carry significant value to multiple Regulatory Affairs activities and teams.

Example Responsibilities

• Represents regional Regulatory Affairs or may serve as Regional Lead on cross-functional/cross-regional Regulatory Submission Teams.
• With guidance, defines the regulatory strategy for one or more products or projects.
• Proactively identifies regulatory or related risks/issues and develops mitigation and/or contingency plans.
• Leads the preparation, compilation, and timely filing of regulatory submissions, which require cross-functional interactions for commercial products). Examples include, IND/NDA amendments, and routine submissions (e.g., Development Safety Update Reports / DSURS, NDA Annual Reports, Periodic Safety Update Reports (PSURs) etc.).
• Leads cross-functional teams in the authoring of regulatory documents, including responses to health authority questions
• Provides input to the content of the original label and label updates.
• Ensures product packaging and associated information is updated and maintained in accordance with the product license for assigned products and markets.
• Critically reviews documents for submission to regulatory authorities.
• Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.

Requirements

Education & Experience

• PharmD/PhD with some relevant experience.
• MA/MS/MBA with 6+ years' relevant experience.
• BA/BS with 8+ years' relevant experience.
• Significant regulatory, quality, compliance or related experience supporting medicinal products.
• Significant regulatory experience in the biopharma industry is strongly preferred.
• Experience setting the regulatory strategy and leading regulatory submissions and other activities for a medicinal product is strongly preferred.
• Experience successfully leading departmental and cross-functional teams without authority.
• Experience authoring and implementing processes.
• Experience working with one or more therapeutic areas and in the post marketing stage of drug development is 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.

Knowledge & Other Requirements

• Demonstrated ability to be a fast learner.
• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
• Demonstrates advanced knowledge of regulatory requirements and the role of regulatory affairs in achieving cross-functional drug discovery and development goals and objectives, including ICH standards and the regulatory requirements for assigned markets
• In-depth knowledge of relevant health authorities, including people, system, processes and requirements, as evidenced by past effectiveness and successes in conducting HA interactions.
• Able to represent to regulatory authorities when managing standard or more routine negotiations.
• Demonstrates strong analytical thinking skills, attention-to-detail, strong communication and writing skills, project management skills and proficiencies with Microsoft Office suite, as evidenced through accomplishments in past roles.
• Ability to lead and influence programs, projects and/or initiatives
• Strong interpersonal skills and understanding of team dynamics.
• Proven ability to work successfully in a team-oriented, highly-matrixed environment.