Regulatory Affairs Manager

Job Description

Basic Functions & Responsibility (may not be limited to):

1. For assigned products, ensures timely preparation, submission, and appropriate follow-up of new Marketing Authorization applications to the local authorities and – as applicable – to the COFEPRIS.
2. Ensures maintenance of assigned, authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations.
3. For assigned products ensures timely, accurate and compliant labelling translations and artwork preparation.
4. Supports the agency interactions to ensure a seamless submission, assessment, and quick approval of CMC variations, non-CMC variations, renewals, OMA, according to the Mexican Regulation, in cooperation with RAI Liaison, iCMC and other internal stakeholders as applicable.
5. For assigned products and tasks, stays updated on late our company pipeline filings, relevant local regulations, and guidelines and to develop and maintain positive relationship with key players in the regulatory environment. Designs and implements regulatory ad-hoc local action plans, as necessary.
6. Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
7. For assigned products and tasks, works alongside the BD, locally and regionally to support business initiatives in sub region.
8. Maintains a positive relationship with internal and external regulatory contacts. GRACS on regional and global level.
9. External contacts are regulatory authorities, as well as other key players in the regulatory environment such as Trade Associations.
10. By discretion of Regulatory Affairs Management and due to organization and workload, all listed activities need not to be performed.
11. Responsible for people management of applicable Regulatory personnel in Country and provides clear leadership for these. Secures appropriate career development for the applicable staff and is responsible for keeping the applicable staff scientifically and legally updated within the Regulatory area.
12. Acts as substitute for Country Lead Regulatory Affairs as appropriate.

Major Activities (may not be limited to):

1. New MA applications for assigned products.
2. Ensures timely and correct submission and approval of assigned new Marketing Authorization applications in close cooperation with relevant persons in the managing, medical, finance, business unit, RAI regional level, as well as with local regulatory authority as appropriate.
3. Manages answers to objections from the Agency on products registration and major new indications, involving negotiations to achieve best conditions.
4. Designs and implements local action plans for new products, involving selection and regulatory training of external experts and closely interacting with the Agency.

Maintenance of licenses for assigned products:

1. Ensures that marketing authorizations are maintained in compliance with related regulatory areas, through performing the necessary activities, including variations and renewals, with a high standard and within the agreed timeframes and communicates approvals to stakeholders through the correct processes.
2. For major indications, designs and implements local action plans as above mentioned for new MA applications.

Compliance

1. For assigned products, ensures timely preparation and Patient Package Inserts, local physicians' circulars, packaging material and other applicable regulatory documents according to our company and local standards and Artwork Management procedures. Implement Prescribing Information within the correct timeframes for compliance.
2. Ensures that all internal customers receive relevant information regarding the regulatory status of the assigned products.
3. Ensures the correct and proper utilization of Artwork Management System to generate artworks.
4. Ensures efficient and consistent implementation and use of internal and external regulatory databases and systems in the country.
5. Ensures that files and archives related to Regulatory are kept updated and complete.
6. Participates in establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations are complied with.
7. Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.

Labelling and artwork

1. Ensures high quality translations and QRD check of Patient Package Leaflets including linguistic check of these documents.
2. Ensures availability of packaging material, including package leaflets and all other artwork in a timely and correct manner and according to relevant Artwork Management procedures.

Cross-functional activities

1. Provides regulatory guidance and support to the license companies/joint venture/co-marketing partners as appropriate.
2. Secures timely and adequate information and decision making in regards to regulatory issues that need to be brought to the attention of the Management Team, such as deletions, divestitures and acquisitions.
3. Takes part in subsidiary product and launch teams to provide regulatory input and strategy advice.

Regulatory Policy & Environment

1. Keeps abreast of local and international laws, collects relevant publicly available regulatory information, provides insights, and responds to consultations on proposed national regulatory guidance, as appropriate, and communicates final regulatory guidance for awareness and impact assessment, in cooperation with Global Regulatory Policy.
2. Advocates for therapeutic areas/local positions on regulatory issues and trends internally (cross-functional internal business partners including PV, market access, policy etc.), and externally (Agency, Industry Association) contributing to a broader policy platform, and through active participation in the regulatory work of the local Pharmaceutical Industry Association the incumbent seeks alignment of industry position with our company interests.
3. Shapes the regulatory environment through liaising with the local agency, local pharmaceutical organization, and other stakeholders.
4. Participates on internal regional regulatory policy workgroups on selected issues.
5. For new regulations, identifies and tracks changes/trends that might impact our company business.
6. Participates in task forces of Pharmaceutical Industry/Agency.

Manage direct report

1. Sets up priorities, organizes, oversees, and monitors direct report's activities, towards division's and country's objectives achievement in compliance with policies and standards.
2. Ensures that direct reports are trained for their proper use of internal regulatory systems.
3. Through attendance to courses/workshops ensures that staff is appropriated updated on new legislations, requirements on Regulatory.
4. Manages, coaches, and develops talent. Maintains a scientific knowledge and expertise for therapeutic areas from our company.
5. Fosters a positive team spirit of the staff.

Local Requirements

1. Cooperates with Quality Responsible in customer complaints, distribution deviations and product recalls according to our company standards and local procedures, as applicable. Closely cooperates with Quality Responsible Person (QRP) / Quality Contact Person (QCP), at wholesaler/distributor/importer level and/or Management (Crisis) team.
2. Shapes the quality environment through liaising with the local agency and other stakeholders, and in concurrence with the local QCP.

Requirements:

• At least 5 years of experience on similar leadership roles
• Advanced level of English
• Strong experience working with Cofepris
• Excellent communication and relations skills
• Experience working with Veeva platforms

Current Employees apply HERE

Current Contingent Workers apply HERE

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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:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

05/10/2025

*A job posting is effective until 11:59:59PM on the day BEFOREthe 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:R343206