Senior Specialist Regulatory Affairs (Oncology)

Labeling and Artwork

• Ensure the timely availability of packaging materials, including package leaflets and other artwork, in compliance with Artwork Management procedures and established timelines.

Cross-Functional Activities

• Coordinate timely and appropriate actions related to deletions, divestitures, and acquisitions.
• Participate in subsidiary product and launch teams, providing regulatory guidance.

Regulatory Policy & Environment

• Monitor and evaluate new and emerging regulations, as well as proposed changes, assessing their potential impact on business and operations.
• As required, Represent the company in task forces organized by the pharmaceutical industry and regulatory agencies, contributing to policy discussions and regulatory strategy.

Qualifications, Skills & Experience

• Degree in Pharmacy, Life Sciences, or a related field, or equivalent qualification.
• Minimum of 8 years of experience in a Registration Department or equivalent role, including interactions with COFEPRIS.
• Strong knowledge of local legislation, procedures, and guidelines governing pharmaceutical products.
• Excellent verbal and written communication skills.
• Strong organizational and planning abilities.
• Experience in Oncology is required, Biological, Biotechnological, small molecules, etc.
• High attention to detail, adaptability, and the ability to manage multiple priorities under tight deadlines.
• Disciplined, proactive, and able to coordinate tasks effectively across teams.
• Ability to navigate complex regulatory environments with diplomacy and assertiveness when engaging with internal and external stakeholders.
• Proficiency in English.
• Client-oriented mindset aligned with our company´s leadership vision.
• Focus on results, strategic planning, accountability, and execution excellence.

Additional location(s) Compensation Information:

Required Skills:

Adaptability, Audits Compliance, Detail-Oriented, Drug Regulatory Affairs, Employee Training Programs, Global Communications, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Process Improvements, Project Management, Regulatory Affairs Management, Regulatory Compliance, Regulatory Operations, Regulatory Strategy Development, Regulatory Submissions

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply 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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

na

Job Posting End Date:

11/13/2026

*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.