Job DescriptionThe Regulatory Affairs Headquarters Principal Scientist is responsible for development and implementation of global regulatory strategy for their assigned projects in the Vaccines and Infectious Disease therapeutic area.Primary activities include, but are not limited to:
Functions with a high degree of independence and provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.
Develops worldwide product regulatory strategy to optimize label and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously.
Provides expert advice to Product Development Teams and subsidiaries on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug.
Provides leadership as head of the Global Regulatory Team, which coordinates cross-functional regulatory support for development programs and marketed products.
Represents our company with external organizations through direct communication with the FDA, including telephone calls and e-mail; chairs meetings between our company and FDA; prepares our company teams for meetings with FDA at all phases of drug development.
Leads cross-functional efforts to prepare for advisory committees and may speak at the advisory committee.
Coordinates interactions with foreign agencies through Regulatory Affairs Europe and the subsidiary registration departments to support their interactions and provide strategic direction across multiple regions simultaneously.
Reviews and provides final approval of Worldwide Marketing Applications, Clinical Study Reports, Protocols, Investigators Brochures before release from our company to external agencies and investigators.
Represents Global Regulatory Affairs (GR) within internal committees to provide regulatory advice and approval according to the committee charters (therapeutic area Document Review Committees, Product Development Team, Early Development Team, and Label Evaluation and Development Team.
Conducts initial Investigational New Drug application/Clinical Study Agreement content review and approval to facilitate initial approval by regulatory agencies for conduct of clinical trials.
Participates in regulatory due diligence activities for licensing candidate review and works with business development partners in executing regulatory responsibilities to advance developmental compounds or support marketed products.
Qualifications, Skills & ExperienceEducation 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 with substantial experience in regulatory affairs to suggest equivalent ability to function in this position.
Required Experience and Skills:
M.D. with minimum of 3 years relevant drug development or clinical experience required, or
Ph.D. with minimum of 5 years relevant drug development experience required, or
M.S. with minimum of 7 years relevant drug development or clinical experience, preference if this experience is in regulatory affairs.
Excellent communication skills (both oral and written).
Good organizational skills with a proven ability to simultaneously balance diverse activities or multiple projects.
Flexibility required.
Strong scientific and analytical skills with attention to detail.
Ability to achieve optimal results with limited day-to-day direction from the manager.
Preferred Experience and Skills:
Substantial experience in regulatory affairs.
Therapeutic area experience in vaccines or infectious diseases. Experience with antibacterial, antifungal or antiviral agents.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)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 (https://survey.sogosurvey.com/r/aCdfqL) 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 Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088EEOCKnowYourRights1020.pdf)EEOC GINA SupplementPay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp%20EnglishformattedESQA508c.pdf)We 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 Acts (https://www.msdprivacy.com/us/en/CCPA-notice/)U.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:$164,800.00 - $259,400.00Available 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 (https://www.benefitsatmerck.com/) .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:DomesticVISA Sponsorship:NoTravel Requirements:10%Flexible Work Arrangements:Not ApplicableShift:Not IndicatedValid Driving License:NoHazardous Material(s):n/aJob Posting End Date:12/2/2024A 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: R320338