Principal Scientist/Director, Regulatory Affairs-CMC (Chemistry, Manufacturing & Controls)

Job DescriptionAs the Director / Principal Scientist in Devices and Drug-Device Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development Programs. You will spearhead regulatory activities for Devices and Drug-Device Combinations (DDDC), ensuring compliance with domestic and international regulations and guidance. This role includes the comprehensive preparation and submission of combination product sections for both commercial and investigational products, such as pre-filled syringes and autoinjectors. Primary responsibilities include, but are not limited to : Serve as the Regulatory Project Lead for assigned device and combination products, guiding cross-functional teams to ensure regulatory compliance throughout development and commercialization. Mentor team members while driving project timelines and fostering a collaborative environmentMaintain in depth knowledge of global device and drug / biologic-device combination product guidelines and policy regarding IND / CTA, original NDA / MAA, agency background packages, post-approval submissions / variations, 510(K)s, CE markings.  Lead the development, communication, and review of Regulatory Strategies and execute on various deliverables for submission and approval of complex INDs, BLAs original NDA / MAA, agency background packages, post-approval submissions / variations, and replies to health authority questions according to defined timelines.Collaborate with partner groups in the authoring and reviewing process to ensure compliance, scientific excellence, accuracy and completeness of submissionsPartner with Device Development, Device Quality, and other Drug stakeholders to communicate and align on new regulations and requirements to ensure internal procedures and processes are compliant for the combination product. Participate in activities and teams related to device and combination productsSupport device design control activities and documentation reviewsProvide evaluations of regulatory state of affairs of any devices and combination products, for due diligence of potential suppliers, partners, or acquisitionsCareful planning, tracking, and communicating regarding submissions and approvals to support continued product supply.Participate in early and late development programs, as well as departmental and cross-functional initiatives aimed at improving combination product content or processes, as needed.Manage or mentor junior team members as needed.Education :  B.S. in a science, engineering, or a related field (advanced degree preferred). Fields of study include Chemical, Mechanical and Electrical Engineering, Biology, Microbiology,  or Biochemistry.Required Experience and Skills : A minimum ten (10) years of industry / regulatory experience (5 years with an advanced degree) in pharmaceutical, medical device or combination product research, development and / or manufacturingExperience in CMC regulatory (IND, CTA, BLA, MAA) with a drug-device product, preferably an autoinjectorDemonstrated sound understanding of related fields (e.g., manufacturing, process development, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly, and conclusions are adequately supported by data. Superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner.Leadership SkillsDemonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholdersDemonstrated flexibility in responding to changing priorities or dealing with unexpected eventsDemonstrated effective leadership, communication, interpersonal and negotiating skills in particular with cross functional partners and health authoritiesPreferred Qualifications : Subject matter expertise in the regulatory development and manufacturing of auto-injector combination productsIn-depth knowledge of the design control process.Preferred fields of study include Biology and Biochemistry.Experience in project management.#GRACSjobs#EligibleforERP Current 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.We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit : EEOC Know Your RightsEEOC GINA Supplement​Pay Transparency NondiscriminationWe are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s 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 presence.This 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 Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.Expected US salary range : $181,600.00 - $285,800.00Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.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 Carefully Merck & 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 : VISA Sponsorship : Travel Requirements : Flexible Work Arrangements : RemoteShift : Valid Driving License : Hazardous Material(s) : Job Posting End Date : 01 / 31 / 2025

• A job posting is effective until 11 : 59 : 59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. SummaryLocation : USA - New Jersey - RahwayType : Full time

Salary : $181,600 - $285,800