Director, Global Regulatory Liaison - Immunology
**职位描述**全球监管联络总干事 （主科学家）报告给总医学执行董事，负责在免疫治疗领域内为其分配项目制定和实施全球监管战略。个人对指定产品提供监管监督，以优化产品标签并获得全球监管机构最短的时间批准。据预计，全球监管联络将独立管理项目，作为这些项目团队的单一，负责和全球接触点，并与世界范围内的监管机构和/或子公司有关于一个或多家公司研究和销售药物/生物学的全球监管战略/注册要求进行互动。此职位需要一名主动，自动激励的领导者，并且能够在执行董事指导下管理复杂程序，可能涉及多种指示，配方或外部合作伙伴。免疫学经验强烈优先**关键功能** - 制定全球产品监管战略，以优化标签并获得监管机构批准分配的指示时间最短 - 评估监管/竞争环境，建立促进市场快速进入和提供目标产品标签的全球监管策略 - 为产品开发团队提供专家建议，作为全球监管领导者以及 GRACS 内部及外部产品的监管单一接触点，就药物整个生命周期中与发展化合物或销售产品相关的问题在监管问题上。- 为全球监管团队提供领导，协调开发方案和市场化产品的跨功能监管支持。- 协调与监管机构和/或子公司的所有申请和提交的准备，提交和后续联系，负责对所有提交和相关文件进行监管审查和最终批准。- 在获得二级市场营销许可时，审查并最终批准本地注册研究协议。- 与监管机构 （FDA,EMA 等）独立互动，包括主导会议，电话会议和书面通信。- 通过与地区监管战略和提交文件的协作，协调区域监管战略
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**Job Description**
The Director (Principal Scientist), Global Regulatory Liaison reports to the Executive Director, General Medicine and is responsible for development and implementation of worldwide regulatory strategies for their assigned projects within the Immunology Therapeutic Area. The individual provides regulatory oversight for assigned products, to optimize product labeling and obtain shortest time to approval by global regulatory agencies.
The Global Regulatory Liaison is expected to independently manage projects, functioning as the single, accountable, global point of contact on those project teams and interact with Worldwide Regulatory Agencies and/or subsidiaries regarding global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics. This position requires a leader who is proactive, self motivated, and who can manage complex programs that may involve multiple indications, formulations, or external partners with direction from the Executive Director. Experience in immunology strongly preferred.
**Key Functions**
- Develops worldwide product regulatory strategies to optimize labeling and obtain shortest time to approval by regulatory agencies for assigned indications
- Assesses regulatory/competitive landscape to establish global regulatory strategies that facilitate speed-to-market and the delivery of targeted product labeling
- Provides 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 drug
- Provides leadership to the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed products
- Coordinates the preparation, submission and follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions and responsible for regulatory review and final approval for all submissions and associated documentation.
- Reviews and provides final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets
- Interact independently with regulatory agencies (FDA, EMA, etc.), including leading meetings, teleconferences, and written communications
- Coordinate regional regulatory strategy and submissions through collaboration with Regulatory Affairs Europe (RAE) and local affiliate teams.
- Reviews Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures
- Prepares IND/CTAs for global studies related to investigational drugs/biologics
- Participates in regulatory due diligence activities for licensing candidate reviews
**Minimum Education & Experience Requirements:**
- B.S. or M.S with a minimum of 7 years of relevant drug development experience with majority in regulatory or
- M.D. or PhD/PharmD with a minimum of 5 years relevant drug development experience with three years in regulatory
**Required Experience:**
- Strong strategic thinking, problem-solving, and continuous learning mindset.
- Effective communicator—both written and verbal—with 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:**
- Therapeutic area expertise in immunology
- Small and large molecule experience
- regulatory affairs experience in major markets (U.S., EU, Japan, China).
#GRACS
#EligibleforERP
**Required Skills:**
Drug Development, Global Regulatory, Pharmaceutical Industry, Pharmaceutical Research, Product Registrations, Regulatory Affairs Management, Regulatory Communications, Regulatory Processes, Regulatory Strategies, Regulatory Submissions, Strategic Leadership
**Preferred Skills:**
Immunology
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.
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The primary location for this posting is:
USA - New Jersey - Rahway
Where required by law, the compensation range for this role is provided below.
The salary range for the primary location of this role is:
$173,200.00 - $272,600.00
This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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 [https://jobs.merck.com/us/en/compensation-and-benefits](https://jobs.merck.com/us/en/compensation-and-benefits).
**Additional location(s):** Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.
**Additional location(s) Compensation Information:**
**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:**
10%
**Flexible Work Arrangements:**
Remote
**Shift:**
Not Indicated
**Valid Driving License:**
No
**Hazardous Material(s):**
n/a
**Job Posting End Date:**
10/30/2026
***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.**