Job Description

　　Looking for someone with a growth mindset.

　　Position Description:

　　The Senior Director, Global Regulatory Lead, is responsible for development and implementation of worldwide regulatory strategy for their assigned projects in the General Medicine therapeutic area. The individual functions with a high degree of independence and provides regulatory oversight for assigned products, in order to optimize label and obtain shortest time to approval by regulatory agencies. Independently manages projects, functioning as the single, accountable, global point of contact on those projects. Independently interacts with the Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/Biologics. Programs may be complex with more than one indication, formulation or have an external business partner.

　　Coordinates the preparation, submission and follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions. Responsible for regulatory review and final approval for all submissions and associated documentation. Provides expertise as Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.

　　Primary activities include, but are not limited to:

　　Reports to Executive Director or Associate Vice President, General MedicineDevelops worldwide product regulatory strategy to optimize label and obtain shortest time to approval by regulatory agencies for multiple indications simultaneouslyProvide expert advice as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products within and external to GRACS on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drugProvide leadership to the staff by leading the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed productsReview and provide final approval of local registration study protocols when needed to obtain marketing authorization in secondary marketsRepresents our company with external organizations through direct communication with the FDA, including telephone calls and e-mail; chair meetings between company and FDA; prepare our company teams for meetings with FDA at any phase of drug developmentLead cross-functional efforts to prepare for advisory committees and may speak at the advisory committeeCoordinate interactions with foreign agencies through Regulatory Affairs Europe and the subsidiary registration departments to support their interactions and provide strategic direction across multiple regions simultaneouslyReview and provide final approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures before release from our company to external agencies and investigatorsRepresent GRA within internal company committees to provide regulatory advice and approval according to the committee charters (including therapeutic area Document Review Committees, Product Development Team, Early Development Team, and label development team)Conducts initial IND/CSA content review and approval to facilitate initial approval by agencies for conduct of clinical trialsParticipate in regulatory due diligence activities for licensing candidate review

　　Position Qualifications:

　　Education Minimum Requirement:

　　B.S., with minimum of 10 years of relevant drug development experience with majority in regulatoryM.S. with minimum of 10 years relevant drug development experience with majority in regulatoryM.D. with minimum of 7 years relevant drug development experience with 5 years in regulatoryPhD/PharmD with minimum of 7 years relevant drug development experience with 5 years in regulatory

　　Required Experience and Skills:

　　Ability to achieve optimal results with limited day-to-day direction from Therapeutic Area Lead.

　　Preferred Experience and Skills:

　　Small and large molecule experienceSubstantial experience in Regulatory Affairs

　　NOTICE FOR INTERNAL APPLICANTS

　　In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

　　If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

　　GRACSJOBS

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　　Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

　　Current Employees apply HERE

　　Current Contingent Workers apply HERE

　　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.

　　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:

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　　Pay Transparency Nondiscrimination

　　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

　　U.S. Hybrid Work Model

　　Effective 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, generally Tuesday, Wednesday and either Monday or 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".

　　Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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 salary range:

　　$175,440.00 - $276,200.00

　　Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

　　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:

　　Domestic

　　VISA Sponsorship:

　　No

　　Travel Requirements:

　　10%

　　Flexible Work Arrangements:

　　Shift:

　　Valid Driving License:

　　Hazardous Material(s):

　　Requisition ID:R270353