Senior Specialist, Regulatory Affairs

Job Description

The Senior Specialist is responsible for the review and approval of US promotional materials.

As a member of the Review Team, work collaboratively with legal, medical, and commercial colleagues to ensure that promotional practices are consistent with regulatory guidelines, our Company policies, and support business objectives

  

Under the direction of a Team Leader or Mentor: develop and implement effective strategies for FDA promotional submissions; manage the development of correspondence with FDA and the interpretation of FDA advisory comments. Conduct regulatory risk analysis and identify regulatory issues.

  

Maintain current awareness and understanding of FDA advisory correspondence, evolving FDA regulations and guidance documents, FDA enforcement letters and policy issues affecting the pharmaceutical/biologics industry. Communicate (written and verbal) basic regulatory positions.

  

Contribute to departmental or cross-functional initiatives to ensure effective and efficient promotional review practices.

Qualifications, Skills & Experience:

Minimum Requirement: 

• B.A. or B.S. degree with an emphasis in science, health care or related fields. 

Preferred:

• Master’s, PhD or PharmD degree with an emphasis in science, health care or related fields. 

• Minimum two years’ experience in pharmaceutical/biologics industry or related field, preferably in the regulatory, scientific, medical, legal or marketing disciplines.

• Basic understanding of FDA regulations relating to advertising and promotion for prescription products with a steadfast focus on quality & compliance.

• Fundamental understanding of the pharmaceutical industry drug development process, including labeling development.

• Understanding of the promotional content development and review processes. 

• Strong verbal and written communication skills. 

• Attention to detail and ability to manage multiple priorities simultaneously. 

• Strong interpersonal skills with ability to demonstrate strategic and analytical thinking. 

• Action oriented with strong cross-functional collaboration skills.

Required Skills:

Adverse Event Report, Biopharmaceuticals, Compliance Investigations, Cross-Functional Collaboration, Detail-Oriented, Drug Development, FDA Regulations, Labeling Compliance, Negotiation, Oral Communications, Pharmaceutical Development, Policy Implementation, Records Retention Management, Regulatory Communications, Regulatory Issues, Regulatory Risk, Regulatory Strategy Development, Regulatory Submissions, Risk Analysis, Technical Writing

Preferred Skills:

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:

EEOC Know Your Rights

EEOC GINA Supplement​

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

$106,200.00 - $167,200.00

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:

10%

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

04/28/2026

*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.