Spclst, Regulatory Affairs

hace 3 meses

Panamá Provincia de Panamá, Panamá MSD A tiempo completo

We invite you to join our Team

This position is in charge of the coordination of the product registration process in order to guarantee the approval to market and distribute new products, permissions to market and/or to import products into the various markets we serve. In addition, for ensuring the appropriate filing/documentation related to product changes.

The major activities and responsibilities are the following:
Regulatory:

- Works with both, local and International strategic initiatives, to improve local productivity and reduce cycle times primarily for the Registrations, renewals and Post Approvals Changes processes.
- Promotes compliance in alignment with our policies, local and international regulations regarding Drug products Marketing Authorizations and Good Manufacturing Practices
- Provides continuous support and feedback to local Marketing and Global Regulatory Affairs teams regarding status and/or issues.
- Plans and performs regulatory processes including preparation of documents for New Registrations, Renewals and Post Approvals Changes processes submission, follow up before the Agency and notification of approval letters.
- Ensure that ORION database and other digital strategies are duly updated with the necessary and/or mandatory records information within the country assigned, in alignment with the pharmaceutical information for each product.
- Coordinates and assures a timely review, development, and approval of the Artworks for packaging materials for all products.
- Works with the Sales Department with Regulatory Documents (Good Manufacturing Practices certificates, Bioequivalence letters and others) for Tender Bids.
- Works with the other regulatory processes as requested by the Manager.
- Provides support to the Regulatory Affairs Team as requested.

Compliance:

- Maintains product license in compliance with market supply, and local authority expectations.
- Ensures alignment with all applicable change control documents.
- Demonstrates knowledge of, and ensure compliance to, all relevant Regulatory legislation and internal procedures.
- Maintains appropriate archive (electronic documentation or paper) to ensure that work is traceable and complies with all appropriate regulations.
- Sets quality standards, by participating in the development of appropriate Standard Operating Procedures and Work Instructions for affiliate activities such as submissions, license maintenance, agency interface, labeling, promotional review, Quality Assurance actions etc., per policies and applicable local regulations.
- Ensures prescribing information, labels and other packaging components are in alignment with regulations and core safety information.
- Coordinates renewal filing plan / Renewal submitted (measured monthly).
- In charge of timely Submission / Approval of variation / Request for change.
- Maintains compliance with labeling database, besides all current databases.

Project Management & Communication:

- As determined, represents Regulatory on cross functional initiatives.
- Works on continuing improvements and simplification.
- Full utilization of Regulatory communication processes.

Minimum Requirements:

- Bachelor’s degree in Pharmacist or related sciences.
- Minimum of one (1) year of experience in Regulatory Affairs at a Pharmaceutical Industry or related.
- Proficiency in local (Spanish) and English languages, in oral and written.
- In terms of knowledge, be familiar with Good Manufacturing Practices and local legal regulations of the Central America & Caribbean countries.
- Ability to work cross-functionally in pharmaceutical company environment, have effective communication skills, leadership behaviors and be well self
- organized.
- Attentive to details, creative and demonstrate initiative, accuracy, team-player skills and be flexible.
- Proficient in Microsoft Office software.

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
No relocation

**VISA Sponsorship**:
No

**Travel Requirements**:
10%

**Flexible Work Arrangements**:
Hybrid

**Shift**:
1st - Day

**Valid Driving License**:
No

**Hazardous Material(s)**:
N/A

**Job Posting End Date**:
10/5/2024

**Job Posting End Date**:10/05/2024

**Requisition ID**:R314599

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