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 dayu2011tou2011day support to ensure products remain compliant throughout their lifecycle.

6. Regulatory Operations

u202FCoordinates the preparation and submission of registration dossiers, variations, renewals, and clinical trial applications, ensuring timely execution
u202FMonitors 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.

Minimum Education:

Bachelor's Degree of Pharmacy or
Bachelor's Degree of Life Science or
Bachelor's Degree of Science

Minimum Experience/Training Required:

At least 5 years of working experience in similar roles
Understanding of regulatory affairs in pharmaceutical environment, experience interfacing with government and regulatory agencies and proven skills in developing and implementing successful regulatory strategies. Strong communication skills to effectively present regulatory information to management and government agencies

Management Skills

Uses resources effectively and efficiently.
Able to plan, prioritize and delegate tasks to project team as needed to ensure timely completion of projects.
Maintain and operate within budget.
Capable of analyzing and investigating issues and problem solving.

Communication Skills

Effectively practices listening skills before responding to issues.
Effectively writes, presents and communicates information to internal and external clients, including divisional management.
Effective negotiation skills.

Total Quality Management (TQM) Skills

Demonstrates the ability to exercise good judgment on regulatory and compliance issues.
Demonstrates an understanding of the appropriate regulatory requirements and applies this understanding to all job responsibilities.

EM Regulatory Affairs Manager (Biosimilar)