Sr. Specialist, Regulatory Affairs

Job Description

This Sr. Specialist position is part of the GRACS US Subsidiary function within our company’s Research Division. Our mission is to serve as a trusted regulatory center of excellence and lead successful interactions with FDA regarding select US topics, primarily including drug shortages, user fee compliance, import/exports, financial disclosure and freedom of information. This is an exciting time to join the US Subsidiary regulatory space, as we navigate evolving expectations and drive impactful change in our industry.

Under the direction of the Director and Associate Director, you will be an integral part of the team, focusing on key activities related to drug shortages, user fees, and freedom of information requests. In this role, you will facilitate interactions with the FDA, monitor changes in regulations, and engage with external industry working groups to advance important issues in the regulatory landscape. The successful candidate will need to adapt to this shifting environment, assist in communicating new regulations or guidance, and support the implementation of necessary changes across the company to maintain compliance. The ideal candidate will have experience collaborating with internal cross-functional stakeholders and engaging with executive management on high-profile issues.

Flexibility and agility in responding to evolving business processes are crucial, as expectations continually change. In this dynamic environment, our team is currently supporting the General Medicine therapeutic area through important projects that drive business success. The Candidate will leverage their knowledge of regulatory and clinical science to contribute to these activities, focusing on research that facilitates the development of regulatory strategy.

The core responsibilities for this Sr. Specialist position include:

• Supporting key compliance activities primarily focused on but not limited to drug shortages, user fees, and freedom of information

• Facilitating execution of direct interactions with FDA

• Monitoring the regulatory landscape and the effect changes will have on the department/company

• Engaging with external industry working groups or associations to advance key topics in the regulatory landscape

• Conducting regulatory research in support of General Medicine therapeutic area priorities

• Maintaining and coordinating departmental and organizational resources, including but not limited to Standard Operating Procedures, Executional Resources

• Tracking and analysis of key department metrics to make appropriate recommendations

• Executing special projects within the division/area, as needed

Education:

Graduate degree in life sciences (MS, PharmD, etc) with 3+ years of relevant experience or BS degree in life sciences with 5+ years of relevant experience in a biopharmaceutical regulatory role (in industry or within a health authority) or related role (e.g., Quality, Supply Chain, or Pharmacy)

Required/Preferred Skills & Experience

• Ability to communicate effectively, both verbally and written, across organizational levels

• Ability to apply regulatory and clinical science knowledge to support regulatory activities within the General Medicine therapeutic area

• Strong teamwork with many stakeholders (internal/external) and negotiation skills

• Proficient with computer systems (MS Office necessary; Advanced Excel and Word skills, PowerBI/Power Apps, AI experience preferred)

• Demonstrated leadership, initiative, and ownership of deliverables

• Ability to independently solve complex problems

• Flexibility and agility to respond and adapt to evolving regulatory and business processes

• Outstanding time management; the ability to balance a large project load

• Direct engagement with FDA and/or other governmental agencies, preferred

• Knowledge of FDA regulations, preferred

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.

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:

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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

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, 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 salary range for this role is

$104,200.00 – $163,900.00

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 https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Adaptability, Adaptability, Audits Compliance, Biological Sciences, Business Processes, Clinical Medicine, Clinical Sciences, Collaborative Development, Continuous Monitoring, Detail-Oriented, Drug Regulatory Affairs, Employee Training Programs, FDA Regulations, Global Communications, Government Agencies, Leadership, Life Science, Management Process, Mentorship, Microsoft Office, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Process Improvements, Project Management, Regulatory Affairs Compliance {+ 5 more}

 Preferred Skills:

Job Posting End Date:

07/10/2025

*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.