Regional Regulatory Lead ...

Job Description Not for Candidates located in India.We are looking for someone who can start immediately Applicationsfrom locations other than UK / EU Countries will not be consideredAbout Freyr Freyr is a fast-growing, innovative companyspecializing in providing end-to-end regulatory solutions andservices for the Life Sciences industry. With a commitment toexcellence and innovation, we assist pharmaceutical, medicaldevice, and biotech companies in navigating the complexities ofregulatory compliance. Why Freyr? At Freyr, we believe in fosteringa collaborative and dynamic work environment that empowers our teamto make a real impact. As we expand our footprint , we are on thelookout for passionate and skilled Regulatory professionals to joinus in shaping the future of regulatory services. Join Our Team: Ifyou're ready to embark on a journey of growth and innovation,connect with us to explore the exciting opportunities awaiting youat Freyr. Together, we can shape the future of regulatorysolutions. 📢 To Apply: Please apply to this job post or you canvisit our Careers page for more openings Visit our Careers page at(https://www.freyrsolutions.com/careers/current-positions) toexplore current job openings and submit your application. Don'tmiss this chance to be a part of Freyr's expansion and make yourmark in the world of regulatory services. Let's redefine regulatoryexcellence together! Title : Regional Regulatory Lead / AssociateDirector - Regulatory Affairs Location : Remote ( Base locationshould be in UK / EU- preferably in Hungary/ Poland / Romania/Czech/ Croatia) Experience : Min 8 years of direct experience withMedicinal Product Regulatory Affairs Role Summary - Serve as aregional regulatory lead (RRL) in the EU and be the point ofcontact for the local health authority (EMA) for select products. -Accountable for the definition and execution of regional RAstrategy for assigned products) which includes, but is not limitedto: - Provide knowledge and input to Global Regulatory Lead (GRL)to advance the product in-line with CorporateObjectives/Established Products Project Team (EPT) Goals - Ensurefulfilment of regional regulatory commitments, in addition tosupporting the regulatory submission activities. - Leverage RAexperience of wider regional/in-country affiliate RA teams toprovide technical and strategic guidance to GRL on innovativeapproaches, precedents, and possible risk mitigations of product. -Represent the regulatory department and actively participate atcross functional teams. - To act as the subject matter expert (SME)and provide valid regulatory guidance to support ongoing regulatoryactivities (EU) - Build and maintain strong relationships withcross-functional teams. - Build, maintain, and advance partnershipswith key stakeholders across RA (including affiliates/distributorgroup). - Act as a delegate for GRL, as appropriate Key activitiesKey Activities: Strategic activities associated with this role mayinclude, but is not limited to: - Ensuring Maintenance of regionalinvestigational and marketing applications (MAAs, CTAs, /BLA/Orphanapplications) in alignment with local regulations - Participationin preparation/lead preparation and submission of routine aggregatereports such as PSUR/PBRER/DSUR/PADER/ Annual Report -Participation/regional leadership for sunsets and/or divestments -Lead local license withdrawal/renewal activities - Representationat cross-functional meetings - Study Management Team (SMT),Established Products Project Team (EPT) (as needed) - RegulatoryIntelligence related to program needs e.g. research on precedence,impactful guidance documents, competitor intelligence, new/amendedregulations process Improvement Initiatives Experience &skillset Position Overview for Established Products You willtypically act as the Regional Regulatory liaison for the assignedproducts, compounds, indications or projects in the assignedtherapeutic area. With guidance, you will define the regulatorystrategy, plans and objectives for the assigned products orprojects. You will typically lead the Regulatory Submissions Teamsassociated with assigned products or projects and represent GlobalTA Regulatory to cross-functional sub-teams. You may serve as acontact to / for regulatory authorities. You will oversee andmanage the work of less experienced colleagues supporting yourwork. You will coach and advise less experienced colleagues incompleting their work and developing their regulatory capabilities.You will typically be assigned products, compounds, indications orprojects of increasing complexity. You will also typically play amore active role in process improvements and other special projectsthat can carry significant value to multiple Regulatory Affairsactivities and teams. Example Responsibilities - Representsregional Regulatory Affairs or may serve as Regional Lead oncross-functional/cross-regional Regulatory Submission Teams. - Withguidance, defines the regulatory strategy for one or more productsor projects. - Proactively identifies regulatory or relatedrisks/issues and develops mitigation and/or contingency plans. -Leads the preparation, compilation, and timely filing of regulatorysubmissions, which require cross-functional interactions forcommercial products). Examples include, IND/NDA amendments, androutine submissions (e.g., Development Safety Update Reports /DSURS, NDA Annual Reports, Periodic Safety Update Reports (PSURs)etc.). - Leads cross-functional teams in the authoring ofregulatory documents, including responses to health authorityquestions - Provides input to the content of the original label andlabel updates. - Ensures product packaging and associatedinformation is updated and maintained in accordance with theproduct license for assigned products and markets. - Criticallyreviews documents for submission to regulatory authorities. -Ensures own work complies with established practices, policies andprocesses, and any regulatory or other requirements. RequirementsEducation & Experience - PharmD/PhD with some relevantexperience. - MA/MS/MBA with 6+ years' relevant experience. - BA/BSwith 8+ years' relevant experience. - Significant regulatory,quality, compliance or related experience supporting medicinalproducts. - Significant regulatory experience in the biopharmaindustry is strongly preferred. - Experience setting the regulatorystrategy and leading regulatory submissions and other activitiesfor a medicinal product is strongly preferred. - Experiencesuccessfully leading departmental and cross-functional teamswithout authority. - Experience authoring and implementingprocesses. - Experience working with one or more therapeutic areasand in the post marketing stage of drug development is stronglypreferred. Rest of World Education & Experience BA/ BS oradvanced degree in life sciences or related field with significantregulatory experience in the biopharma industry, regulatory agency,clinical research or other related healthcare environment.Knowledge & Other Requirements - Demonstrated ability to be afast learner. - Demonstrated ability to be flexible and adaptableto change, to move between projects easily and providesupport/expertise where needed. - Demonstrates advanced knowledgeof regulatory requirements and the role of regulatory affairs inachieving cross-functional drug discovery and development goals andobjectives, including ICH standards and the regulatory requirementsfor assigned markets - In-depth knowledge of relevant healthauthorities, including people, system, processes and requirements,as evidenced by past effectiveness and successes in conducting HAinteractions. - Able to represent to regulatory authorities whenmanaging standard or more routine negotiations. - Demonstratesstrong analytical thinking skills, attention-to-detail, strongcommunication and writing skills, project management skills andproficiencies with Microsoft Office suite, as evidenced throughaccomplishments in past roles. - Ability to lead and influenceprograms, projects and/or initiatives - Strong interpersonal skillsand understanding of team dynamics. - Proven ability to worksuccessfully in a team-oriented, highly-matrixedenvironment.