Regulatory Affairs Specialist - Long term project Setúbal

Regulatory Affairs Specialist - Long term project
Setúbal
Setúbal, Setubal, Portugal

Company profile

For the past 20 years, Pro
Pharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), Pro
Pharma partners with its clients through an
-
- operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, Pro
Pharma offers an
-
- end suite of fully customizable consulting solutions that
- risk and accelerate our partners’ most
- profile drug and device programs.

Position overview

Pro
Pharma is currently supporting an international Pharmaceutical group as they require support within their Portuguese affiliate mainly Regulatory Affairs on a project basis (2 years). At present, we are looking to partner with an experienced
- sciences professional in the Regulatory Affairs area who has the ability to work on a long term contract for 2 years on a full time basis (40 hours per week). The role is planned to commence in October 2025 and requires hybrid working in their Lisbon office throughout the project.

Responsibilities

• Support timely preparation, submission and follow up of new MA applications to the local NCAs and support the maintenance of authorized medicinal products through timely preparation and/or submission of variations, renewals or PSURs
• Ensure compliance with the company policies and relevant regional and local regulations
• Reviewing promotional and
  - promotional materials
• Support the collection of relevant public available regulatory information
• Other tasks and learning opportunities would consistent of support QMS activities; becoming the deputy Responsible Person and in general supporting the Quality system in Portugal

Qualifications

• Must have a BSc or MSc degree in Pharmaceutical Sciences (preferred) or within another Life Science discipline
• 3 years’ experience or more in Regulatory Affairs area within a pharmaceutical company leading and managing national RA activities in Portugal
• Fluency in English and Portuguese (native) is a must
• Can demonstrate key experience which is required within the job spec
• Can commence a new contract in October for two years
• Live within commutable distance of Lisbon to work office based for two days a week

Additional information

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

Pro
Pharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting. **