EM Regulatory Affairs Manager Abbott Laboratories

JOB DESCRIPTION:

Primary Job Function:

• Supports affiliates in the execution of registration plans, ensuring timely and compliant submissions across EM markets including but not limited to Biosimilars
• Monitors progress of product registrations and maintains oversight of regional regulatory timelines and requirements.
• Provides coordination and operational support to local Regulatory Affairs teams to ensure alignment and regulatory compliance.
• Support collecting and interpreting the guidelines related to Biosimilars

Core Job Responsibilities:

1. Product registrations /Submissions

• Coordinate the execution of the regulatory strategies ensuring close monitoring and follow up with the affiliates and timely reporting.

2. Relationships & Cross Functional teamwork

• Ensure good collaboration and relationship with the regulatory teams in the affiliate and the emerging markets
• Supports the internal stakeholders for any regulatory affairs ad-hoc request

3. Affiliate Coordination

• Maintains effective working relationships with local RA teams and global RA teams
• Ensure proper coordination between the RA affiliates and stakeholders in the defined areas

4. Compliance across lifecycles

• Supports the coordination of new product registration activities ensuring alignment with regulatory requirements and business timelines.
• Provides day to day support to ensure products remain compliant throughout their lifecycle.

6. Regulatory Operations

• Coordinates the preparation and submission of registration dossiers, variations, renewals, and clinical trial applications, ensuring timely execution
• Monitors timelines for key submissions (e.g., new registrations, variations, CCDS updates, PSURs, license renewals) and supports affiliates to ensure continuity of product availability.

Position Accountability/Scope:

Accountable that the business remains compliance with all regulatory aspects (local and Abbott policy) and all regulatory agency submission materials are within timeliness, accuracy, comprehensiveness and compliance with regulatory standards.