Regulatory Affairs Coordinator Abbott Laboratories

JOB DESCRIPTION:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

We are currently seeking candidates ( External contract) for our Established Pharmaceuticals Division to join our FAC Regulatory Affairs Team.

Job Description :

- Collaboration: Collaborate with business development and marketing to establish appropriate short, medium, and long-term regulatory strategies by integrating new products into Abbott's portfolio.

- Regulatory Plans: Prepare regulatory plans and ensure their implementation to achieve long-term objectives regarding products that can be qualified in terms of sales, market share, and profit contributions.

- Internal Collaboration: Work closely with various manufacturing, quality assurance, and development sources to develop, approve, and implement labels within the timeframe agreed upon with management.

- Logistics Coordination: Work closely with the logistics department to organize the delivery of samples within the specified deadlines.

- Regulatory Documentation: Prepare regulatory dossiers for new products, renewals, and variations.

- Marketing and Medical Collaboration: Collaborate closely with the marketing and medical departments to review and approve promotional materials in accordance with agreed guidelines and within the specified deadlines.

- GPRA Coordination: Work with GPRA to prepare dossiers for new products, renewals, and variations.

-Communication : Maintain effective communication with local representatives and relevant authorities.

Compliance :

- SOP Compliance: Be responsible for compliance with regulatory SOPs and identify opportunities for improvement in these procedures.

- Corporate Values: Relay Abbott's corporate values and train new recruits.

- Training: Ensure that training is carried out as agreed.