Job Description

Our Company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our Company has codified its 125-year legacy. Our Company’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.  The Operations, Process and Systems (O.P.S.) organization plays a pivotal role in executing core regulatory strategies and business operations capabilities across the Global Regulatory Affairs and Clinical Safety (GRACS) organization.  O.P.S. leverages diverse skill sets to deliver core regulatory operations capabilities spanning submissions planning and execution, labeling and artwork support, and regulatory information management to support the full lifecycle of our biopharmaceutical products which deliver on the company mission of saving and improving lives.

The GRACS Operations, Process & Systems (OPS) Hub Site Lead role is responsible for (1) establishing and expanding the local GRACS OPS capabilities in coordination with OPS Functional Areas and (2) managing Regional Regulatory Operations staff located at the site execution regulatory operations activities (e.g. submissions planning & execution along with labeling and artwork coordination activities)

OPS Site leadership is responsible for ensuring effective coordination of local site activities across all OPS functional areas. The individual will work closely with various OPS functional areas and collaborate with key stakeholders at global, region and headquarters. The Hub Site Lead is responsible for fostering a high-performing, collaborative, and inclusive environment that enables delivery excellence, innovation and efficiency across GRACS OPS Hub functions.

OPS Site Leadership will additionally have direct managerial responsibilities for Regional Regulatory Operations staff located at the hub site.  This position will be responsible for executing regulatory operations activities.  The role will be involved with assigned operational work e.g. Submission Planning as well as provide local managerial oversight on the execution of Regional Regulatory Operations hub work that encompasses submission planning and execution, and labeling and artwork coordination activities, while serving as the primary interface with internal stakeholders, site-level governance bodies, and functional leaders. The geographical scope of regional regulatory operations activities may support EU & EEMEA, AP or other global capabilities with collaboration across local, regional & global stakeholders as needed.

Job Description and Responsibilities

The primary activities include but are not limited to:

O.P.S. Hub Site Lead: In collaboration with HQ and Regional functions,  provide overall OPS direction for regulatory operations at the site, aligning local activities with GRACS global, corporate goals and regulatory requirements.

Serve as the primary point of contact for GRACS OPS at the Hub site. Serve as the O.P.S. escalation point for Hub-related challenges and support issue resolution within the OPS team.

Stakeholder Communication: Act as a primary point of contact for OPS for internal and external stakeholders to facilitate effective communication and collaboration.  This complements the role of the functional areas which are accountable for delivery and execution. Represents GRACS OPS in local leadership councils and site governance bodies.

General Administrative: Leads overall site administration by representing GRACS OPS in site-based activities and ensuring coordination across key support functions including Facilities, IT, EHS, and Legal. Ensure adequate resource planning, office logistics and local onboarding of new employees. Monitor organizational site metrics and assess opportunities for cross-OPS resource utilization as appropriate. Support Local HR Driven initiatives and ensure OPS practices remain consistent and aligned across different regions.

Engagement Champion: Drives culture, communication, diversity & inclusion, talent development, and employee engagement initiatives to foster a strong, values-driven workplace in alignment with co-locating functions

Training and Development: Implement training programs to ensure that team members are informed of current regulatory standards and best practices. Also, identify training needs across the Hub and support implementation. Promote cross functional learning and knowledge-sharing.

Regulatory Regional Operations Manager:

Lead and develop direct line reports at the Hub creating an environment that fosters professional growth

Accountable for Individual Work Tasks & Assignments e.g. Submission Planning ensuring these tasks are completed on time.

Operational Execution & Delivery: Accountable for ensuring timely execution to high standards for quality & compliance for all RRO deliverables produced at the Hub, some of which will be worked on by the OPS Hub Lead themselves. Contribute to decision-making processes by providing insights and recommendations based on local expertise and operational needs

Continuous Improvement: Drive process efficiency and operational excellence by establishing streamlined workflows for related activities, aligned with global processes and standards.

Regulatory Compliance: Ensure that all regulatory activities comply with relevant laws, guidelines, and policies. This includes overseeing submissions, documentation, and ensure that appropriate inputs are provided to support audits or issue management. 

RRO Talent Management: Support performance management and development plans as well as overall engagement for direct reports. Create an inclusive and collaborative work culture that supports engagement and innovation

Support RRO Regional Leads by providing essential site-related updates, logistical support, and insights into local country operational dynamics.

Qualifications

Education:  Bachelor’s degree in a Life Science, Pharmacy, or Engineering-related field required.

Advanced degree preferred

Project Management Professional certification (PMP) or Scrum Master certification (CSM) or similar is preferred

Experience and Skills Required:

At least 10 years experience in the pharmaceutical industry including 2 years of regulatory operations or regulatory affairs area.  

5+ years experience in people management

Excellent people management skills

Strong written and oral communication skills in English. 

Proficient project management skills with the ability to handle multiple tasks and prioritize effectively.

Very strong negotiation, communication, interpersonal and reasoning skills

Excellent presentation skills

Growth mindset and bigger picture seeking individual

Tech savvy professional including Microsoft Suite and Power BI experience

Demonstrated ability to analyze, define, and solve related problems and advising functional area leads on managing risks

Ability to work toward enterprise goals, using influence rather than control, and fostering a work environment based on trust, sharing, and collaboration.

Ability to collaborate with diverse stakeholders in a variety of project environments

Team player

Proactive and action-oriented approach

“#GCSPV25“

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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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Adaptability, Adaptability, Business, Change Management, Communication, Cross-Cultural Awareness, Data Management, Employee Engagement Strategies, Employee Training Programs, FDA Regulations, Legal Compliance, Management Process, Multi-Management, Operational Excellence, Operational Execution, Organization Administration, People Management, Pharmacovigilance, Policy Implementation, Project Management, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Requirements {+ 5 more}

 Preferred Skills:

Job Posting End Date:

08/16/2025

*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.

Requisition ID:R349520