Associate Principal Scientist, Regulatory Liaison

Job Description Brief Description of Position The Regulatory Affairs Headquarters Associate Principal Scientist supports products in the Vaccine and Infectious Disease (VID) therapeutic area as part of a regulatory team. They will have excellent communication and collaboration skills and will work closely with a global liaison(s) to help develop and implement a global strategy for registration and/or maintenance of VID products. Responsibilities may encompass all aspects of planning and implementation of a global regulatory strategy and regulatory submissions including assisting in preparing submissions, protocol review, and conducting research on regulatory guidance's or competitive intelligence. Primary activities include, but are not limited to: Assists in regulatory agency communications and submissions, including but not limited to: marketing applications, Investigational New Drug Applications (INDs), pediatric plans and annual or other periodic reports. The individual may also assist or take the lead in tracking, authoring, shepherding and/or review of responses to Agency requests. Implements strategy to develop agency background packages and documents associated with regulatory submissions for marketing applications. Communicates with agencies and attending agency meetings to assist the Global Liaison. Participates as an active member on the Global Regulatory Team. They will attend cross-functional meetings as required, in collaboration with, and to assist the global liaison. Conducts research and review of guidelines, regulatory precedence and competitive Intelligence to facilitate development of regulatory strategy. Assists the global liaison in authoring of regulatory strategy documents. Collaborates and communicates regulatory strategy as needed to colleagues in Regulatory Operations, Clinical Safety, Labeling, Regulatory Chemistry, Manufacturing and Control (CMC) as well as other functional areas (e.g., Clinical Research, Safety Assessment). Supports maintenance (e.g., quality compliance and life cycle management) of VID programs. Supports of Global Liaison in label development. Assists with process improvement initiatives. Performs regulatory administrative activities as needed. Qualifications, Skills, and Experience Education Minimum Requirements M.D. or Ph.D. or other related doctoral degree in biological science, chemistry or related discipline. Other degrees such as master's or bachelor's with experience to suggest equivalent ability to function in this position. Required Experience and Skills M.D. or Ph.D. or other related doctoral degree in biological science, chemistry or related discipline, or Master's degree with at least 3 years of relevant experience in pharmaceutical industry, or Bachelor's degree with at least 6 years of relevant experience in the pharmaceutical industry Excellent communication skills (both oral and written). Good organizational skills with a proven ability to simultaneously balance different activities or multiple projects. Flexibility required. Strong scientific and analytical skills with attention to detail. Preferred Experience and Skills Prior regulatory experience. Experience in drug development, particularly anti-infectives and/or vaccine products is highly preferred. Required Skills: Adaptability, Cross-Functional Teamwork, Exercises Judgment, Life Cycle Planning, Meeting Facilitation, Pharmaceutical Industry, Pharmaceutical Research, Pharmaceutics, Process Improvements, Regulatory Affairs Management, Regulatory Communications, Regulatory Documents, Regulatory Experience, Regulatory Management, Regulatory Processes, Regulatory Reporting, Regulatory Strategies, Regulatory Strategy Development, Regulatory Submissions, Strategic Thinking, Strategy Development Preferred Skills: US 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 characteristics.--As 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 Rights EEOC GINA Supplement We 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 another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $142,400.00 - $224,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's 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 . San Francisco Residents Only: -We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los 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 Ordinance Search 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: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 10/7/2026 *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. Requisition ID:

R418869

#J-18808-Ljbffr Merck & Co.