Abbott - Specialist - Regulatory Affairs - CRLB

Main Purpose of Role:

We are seeking an experienced Regulatory Affairs Specialist who will operate as an individual contributor under limited supervision. The role requires applying subject matter expertise in Regulatory Affairs to ensure compliance and successful product approvals. The ideal candidate will have the capacity to adapt their skills and knowledge to meet specific organizational and regulatory requirements.

Key Responsibilities:

Regulatory Submissions & Compliance:

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

- Ensure timely and accurate documentation in line with regulatory standards.

Regulatory Liaison:

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

- Serve as the primary regulatory point of contact throughout the product lifecycle.

Product Lifecycle Management:

- Participate in product planning, regulatory strategy formulation, risk management, and Chemistry Manufacturing Control (CMC) processes.

- Ensure timely approval and ongoing compliance for new drugs, biologics, or medical devices.

Cross-Functional Collaboration:

- Act as the regulatory representative in interactions with marketing, research teams, and external agencies.

- Advise internal teams on manufacturing changes, line extensions, technical labeling requirements, applicable regulations, and regulatory interpretations.

Qualifications & Skills:

- Education: MBA or equivalent in a relevant discipline.

- Experience: 3-5 years of professional experience in Regulatory Affairs within the pharmaceutical, biotechnology, or medical devices industry.

- Strong understanding of relevant regulatory guidelines and submission requirements.

- Excellent communication, analytical, and organizational skills.

- Ability to work independently and manage multiple priorities under tight deadlines.