Regulatory Affairs Senior Associate (M/F) Lisboa Lisboa

Regulatory Affairs Senior Associate (M/F) Lisboa
Lisboa
Lisboa, Lisboa, Portugal

Regulatory Affairs Senior Associate (M/F) Lisboa

Gi Life Sciences is currently recruiting a Regulatory Affairs Senior Associate to work with one of our clients based in the Lisbon area. Our client is one of the biggest biotech companies operating in Portugal, and they are seeking to hire a RA Senior Associate for a temporary 12-month project.

Main Responsibilities:

• The RA Officer will be responsible for ensuring rapid market access for the client’s products and providing optimal support for products already on the market.
• Provide regulatory support throughout the entire product life cycle, including ensuring local labels are developed and maintained in line with local legislation and the client’s standards and procedures.
• Collaborate with Regional and Global Study Operations (GSO) teams to support local planning and execution for In Vitro Devices' performance studies according to national regulatory requirements.
• Contribute to development,
  - approval activities, and Life Cycle Management.
• Liaise with Regulatory Agencies and Local Operating Companies, contribute to document and process development, and support Marketing Authorization Applications (MAA) for Portugal.

Requirements:

• University degree in Life Sciences (pharmacy, biology, veterinary, etc. ) or equivalent by experience.
• Minimum 2 years of relevant regulatory experience.
• International teamwork experience is a plus.
• Project management skills are valued.
• Excellent oral and written communication skills.
• Strong organization and
  - tasking abilities.
• Fluent in English.
• Knowledge of the regulatory environment, guidelines, and practices in Portugal.

If you are interested in applying or want to learn more about this position, please submit your CV through our portal.

In accordance with Regulation (EU) 2016/679 (GDPR), candidates are invited to read the privacy policy at pt. gigroup.com. Gi Group Holding recognizes and respects diversity and promotes equal opportunities through fair processes based on merit and professional competence. We value diversity and aim to create an inclusive culture that eliminates barriers to access, retention, and growth in the workplace. For more information, visit gigrouholding.com/portugal.