Senior Regulatory Affairs Specialist

hace 2 meses

Bogotá, Colombia MSD A tiempo completo

Job Description

Execute the Regulatory Road Map of the products in the Assigned Portfolio. 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.

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, and other regulatory procedures in general, etc.
  • 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.
  • If required, could be responsible of people management responsibility, trainee or contractors.
  • Participation and/or collaborative in trade associations.

Qualifications:

  • Bachelor’s degree in Pharmacist / Pharmaceutical sciences required.
  • Masters or PhD related with pharma o business (MBA, projects, marketing) preferred.
  • Fluent English - speaking, writing, reading- required.

Experience:

  • More than 5 years in pharmaceutical industries in Regulatory affairs positions.
  • Prove deep knowledge in local regulations general and specific for drugs, small molecules, and biologics. With Regulatory experience registering small molecules and biological products.
  • Management internal platforms/programs for regulatory activities.

Skills:

  • Demonstrate ethics and integrity.
  • Focus on the patient.
  • Competitive decision making.
  • Operational and commercial management.
  • Financial and business broad vision.
  • Effective communication.
  • Effective execution capacity. 
  • Sense of urgency, initiative.
  • Strategic thinking.
  • Develop Talent.
  • Regulations and management compliance
  • Data analysis

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

07/18/2024

*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.


Job Posting End Date:07/18/2024


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.


Requisition ID:R302146

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