Job Description
Job DescriptionThe Global Regulatory Liaison is responsible for developing and implementing worldwide regulatory strategies for assigned projects within the Immunology therapeutic area. Acting as the single accountable global point of contact with significant experience the Liaison provides strategic regulatory oversight to accelerate approvals and optimize product labeling.This position requires an experienced leader who is proactive self-motivated and who can independently manage complex programs that may involve multiple indications formulations or external partners. The Liaison engages directly with global regulatory authorities to ensure successful registration and compliance. Global Immunology submission experience in IBD strongly preferred.Primary ResponsibilitiesDevelop and lead global regulatory strategies to support multiple indications optimizing labels and achieving timely regulatory approvals.Serve as an experienced worldwide regulatory representative on Asset or Product Development Teams and act as the regulatory single point-of-contact for assigned products across GRACS and external partners.Provide expert regulatory guidance to cross-functional development teams and regional subsidiaries throughout the product life cycle.Oversee and independently lead the preparation submission and follow-up of regulatory applications and ensure quality and compliance across all documentation.Interact independently with regulatory agencies (FDA EMA etc.) including leading meetings teleconferences and written communications.Lead cross-functional teams in preparation for regulatory advisory committee meetings and may include a speaking role.Coordinate regional regulatory strategy and submissions through collaboration with Regulatory Affairs Europe (RAE) and local affiliate teams.Provide final regulatory review and approval of:Worldwide marketing applicationsClinical study protocols and reportsInvestigator brochuresLocal registration study protocols for secondary marketsRepresent Global Regulatory Affairs on internal committees (e.g. DRC ADT/PDT EDT LEAD) to provide strategic regulatory input and approvals.Conduct initial content review and approval for IND/CSA submissions to enable clinical trial initiation.Participate in regulatory due diligence activities for in-licensing opportunities.Education RequirementsB.S. or M.S. in biological sciences chemistry or related discipline with 10 years of relevant drug development clinical or regulatory experience.M.D. or Ph.D./Pharm D with 7 years of experience.Required Experience and SkillsProven ability to operate independently with minimal direction and deliver results.Strong strategic thinking problem-solving and continuous learning mindset.Effective communicatorboth written and verbalwith the ability to influence lead and negotiate across levels and functions.Experience leading or supporting direct interactions with major Health Authorities (e.g. FDA EMA).Demonstrated expertise in leading regulatory filings across global regions.Preferred Experience and SkillsTherapeutic area expertise in Immunology.Experience with biologics or small moleculesSubstantial experience in US & International Regulatory Affairs with prior experience as a Global Regulatory LeadDemonstrated scientific knowledge writing ability effective communication and thorough familiarity with worldwide regulatory agencies.Outstanding interpersonal communication and negotiation skills.Demonstrated leadership attributes; experienced at building and leading high performing teams or projects; exemplifies corporate and ethical integrity; drives success consistent with company values and priorities.Prior people management experience.#eligbleforERPCurrent Employees apply HERECurrent Contingent Workers apply HEREUS and Puerto Rico Residents Only:Our company is committed to inclusion ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.As an Equal Employment Opportunity Employer we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race color age religion sex sexual orientation gender identity national origin protected veteran status disability status or other applicable legally protected a federal contractor we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws visit:EEOC Know Your RightsEEOC GINA SupplementWe are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences perspectives skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas broad experiences backgrounds and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively.Learn more about your rights including under California Colorado and other US State ActsU.S. Hybrid Work ModelEffective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.The salary range for this role is$187000.00 - $294400.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.The successful candidate will be eligible for annual bonus and long-term incentive if applicable.We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance OrdinanceLos Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring OrdinanceSearch Firm Representatives Please Read CarefullyMerck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.Employee Status: RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:10%Flexible Work Arrangements:RemoteShift:Not IndicatedValid Driving License:NoHazardous Material(s):n/aRequired Skills:Biological Sciences Clinical Immunology Communication Immunology Immunotherapy International Regulatory Compliance Leadership Motivation Management Pharmaceutical Regulatory Affairs Regulatory Affairs Management Regulatory Communications Regulatory Compliance Regulatory Reviews Regulatory Strategies Regulatory Strategy Development Regulatory SubmissionsPreferred Skills:Job Posting End Date:09/20/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Required Experience:Senior IC Key Skills Laboratory Experience,Mammalian Cell Culture,Biochemistry,Assays,Protein Purification,Research Experience,Next Generation Sequencing,Research & Development,cGMP,Cell Culture,Molecular Biology,Flow Cytometry Employment Type : Full-Time Experience: years Vacancy: 1 Monthly Salary Salary: 187000 - 294400
Experience: 5 years required
Apply tot his job
Apply To this Job