Regulatory Affairs Professional
Há 1 mês
Job Summary
We are seeking a highly skilled Regulatory Affairs Specialist to join our team in Portugal. As a key member of our Regulatory Affairs department, you will be responsible for developing and implementing regulatory strategies to ensure compliance with national and European regulations.
Key Responsibilities
- Provide guidance and support to clients regarding regulatory submissions and activities in Portugal.
- Contribute to the development of regulatory strategies and plans for new registrations, renewals, and post-approval applications.
- Assist with the preparation and submission of documentation for regulatory authorities, including Marketing Authorization Applications (MAAs) and Technical/Site Transfer Applications.
- Manage artwork generation, labeling, and creation/update of product information, including review of packaging texts and format review of Summary of Product Characteristics, Patient Information Leaflets, and labeling.
- Respond to internal requests for technical and/or regulatory information and ensure compliance with all regulatory processes.
- Monitor and maintain up-to-date knowledge of national and European guidelines/legislation and use a variety of software packages to produce correspondence and documents.
Requirements
- At least a Bachelor's Degree in Life Sciences, ideally a Pharmacy Degree.
- At least 5 years of experience in Regulatory Affairs in a Pharmaceutical Company or Service Provider.
- PT LifeCycle Maintenance (LCM) experience, ideally EU LCM experience as well.
- Fluency in Portuguese and English.
- Excellent organizational and interpersonal skills.
About Us
Groupe Productlife is a global industry leader in regulatory outsourcing and consulting services for the life sciences industry. We are committed to providing world-class services to our clients and offer a supportive team environment and opportunities for growth and development.
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