Regulatory Affairs Expert for Southern Europe
Há 1 mês
Groupe Productlife is a global leader in regulatory outsourcing and consulting services for the life sciences industry. We are seeking a highly skilled Regulatory Affairs Specialist to join our teams in Portugal.
As a Regulatory Affairs Specialist, you will be part of a dedicated team responsible for ensuring compliance with regulations in Southern Europe. Your primary mission will be to develop and implement regulatory strategies for clients operating in Portugal, including new product registrations, renewals, and post-approval applications.
Responsibilities:
- Provide guidance and support to clients regarding submissions and requests related to Portugal
- Contribute to regulatory activities, including pre-licensing, new registration, and post-approval applications
- Assist with Marketing Authorization Applications (MAAs)
- Prepare and submit documentation for post-approval applications, including Type IA, IB, II, Renewals, MAH Transfers/COAs, 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 labelling
- Respond to internal requests for technical and/or regulatory information
- Ensure compliance with all regulatory processes, preparing for both internal and external audits
- Maintain up-to-date knowledge of national and European guidelines/legislation
- Use software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data (e.g., Microsoft Office Suite, Veeva Vault, LorenZ, Trackwise, PromoMat)
Requirements:
- Bachelor's Degree in Life Sciences, ideally Pharmacy
- At least 5 years of experience in Regulatory Affairs in a Pharmaceutical Company or Service Provider
- PT LifeCycle Maintenance (LCM) experience, preferably EU LCM experience as well
- Hard/Technical skills:
- Experience in regulatory lifecycle maintenance activities for drug products (Renewals, PI updates, technical variations) in PT and ideally EU markets
- Knowledge of PT regulation for pharmaceuticals (NCE, Biologicals, and Biotech), Medical Devices, Combination products, and Cosmetics
- Strong computer skills, including MS Office applications and data/document management systems
- Experience in project management
- Experience in the new registrations of drug products is preferable
- Fluency in Portuguese and English
- Excellent organizational and interpersonal skills
- Very good coordination skills
- A proven ability to consistently deliver to tight timelines, without negatively impacting quality or departmental budget
- Ability to work well within a team and autonomously
- Ability to prioritize different workloads/multi-task
- Process-oriented with good attention to detail
- Solution-driven
Salary: €60,000 - €80,000 per year, depending on experience and qualifications. This position offers an attractive salary package, along with opportunities for professional growth and development within a dynamic and supportive team environment.
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