Abbott - Manager - Regulatory Affairs

Main Purpose of the Role:

The Regulatory Affairs manager is a highly skilled individual contributor with comprehensive expertise in regulatory affairs. The role is responsible for leading and executing complex regulatory projects, developing innovative approaches to compliance, and ensuring timely product approvals. This position serves as a key regulatory liaison across product lifecycles, supporting business objectives while maintaining adherence to applicable regulations.

Key Responsibilities:

- Lead the preparation and submission of product registration dossiers, supplements, amendments, progress reports, and periodic experience reports.

- Interact with regulatory agencies to facilitate and expedite product approvals.

- Serve as a regulatory liaison throughout the product lifecycle, ensuring compliance with global and local regulatory requirements.

- Contribute to product planning and implementation, including regulatory strategy, risk management, and chemistry manufacturing control (CMC).

- Ensure timely approval of new drugs, biologics, or medical devices, and continued approval of marketed products.

- Advise cross-functional teams (marketing, R&D, manufacturing) on regulatory requirements, technical labeling, line extensions, and interpretation of applicable regulations.

- Monitor and assess regulatory changes, providing guidance to internal stakeholders on potential business impact.

Qualifications:

Education - Bachelor's or Master's degree

Experience:

- Minimum 7 years of experience in Regulatory Affairs, with demonstrated expertise in submissions, regulatory strategy, and agency interactions.

- Strong understanding of global and local regulatory guidelines (e.g., FDA, EMA, CDSCO).

- Experience in drug development, biologics, or medical devices preferred.

Skills & Competencies:

- In-depth knowledge of regulatory requirements and processes.

- Excellent project management, analytical, and problem-solving skills.

- Strong written and verbal communication skills for effective interactions with regulatory authorities and internal stakeholders.

- Ability to work independently as a subject matter expert while collaborating with cross-functional teams.