Merck
Job Description
Execute the Regulatory Road Map of the products in the assigned portfolio and at a transversal level as required by the area. Ensure compliance with local regulations to achieve the regulatory objectives for the subsidiary. Provide advisory and support to HQ stakeholders, marketing, logistics, quality, planning divisions, among others, in the projects that are required. Interact with the agency, follow up on regulatory filings and procedures related with the portfolio and projects assigned as required. Also, this role is responsible for leading the evaluation and notification of Promotional and Non-Promotional Materials of the company, as required, to the regulatory agency.
Main functions:
Be updated on new or changes in laws, regulations, normative, in force or under proposal to keep the company aware and in compliance with the different government regulations.
Ensure and execute regulatory strategy and compliance for preparation, submission and monitoring of the regulatory procedures such as: New Registrations (OMA), New indications, Renewals, Variations (PAC), and other regulatory procedures in general, etc. for the assigned Portfolio and at a transversal level as required.
Evaluate, review, and timely present to the regulatory agency the materials used from Oncology, Pharma, Vaccines, and Access business units in promotional and non-promotional activities as required. Ensuring compliance with current regulations and providing cross-functional support in the impacted processes.
Support Tenders and Sales (and other areas that may require it) obtaining the necessary documentation for their processes (eg: Letters, GPM, Certifications, among others)
Establish good working relationships with both internal and external staff (regulatory agency, associations, regulatory consultants) maintaining a professional image on behalf of the company.
Execute labeling updates (information to prescribe and insert) of the products within the established due dates. Planning filing and implementation in compliance with what is approved or required by HQ and the regulatory agency.
Protect the company's information by ensuring that it is not disclosed except when necessary and when it is duly covered with the appropriate confidentiality agreements.
Execute Regulatory Road Map for portfolio assigned.
Provide revision to local RA SOPs updates and comply with the established there.
Maintain updated the certificates of Good Manufacturing Practices of all the corresponding sites and Certificates of Pharmaceutical Products for portfolio assigned.
Perform trainings as required within the established times.
Perform champion/SME tasks of the assigned process or internal system.
Keep updated the different corporate regulatory tracking, repository, or archive tools, etc. within the established times, maintaining KPIs with required standard.
Request artworks updates when apply through the corporate system, ensuring right first time within the established times.
Participation and/or collaborative in trade associations.
Qualifications:
Experience:
Required Skills:
Adaptability, Detail-Oriented, Electronic Common Technical Document (eCTD), Employee Training Programs, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Experience, Regulatory Reporting, Regulatory Strategy Development, Regulatory Submissions, Technical Writing
Preferred Skills:
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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:
Project Temps (Fixed Term)
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Hybrid
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
09/25/2026
*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.