Medical Information & Regulatory Affairs Specialist

Descripción del puesto:

Shape the future of science with AstraZeneca! We are a global, science-led, patient-focused biopharmaceutical company transforming ideas into life-changing medicines. In Portugal, our purpose is to advance clinical practice and reduce the burden of chronic diseases and cancer by facilitating patient access to innovation-raising awareness, supporting early identification of symptoms, and helping implement treatments aligned to best evidence and medical guidelines.

As Medical Information & Regulatory Affairs Specialist, you will operate at the intersection of science, communication, and regulation to enable safe, effective access to AstraZeneca therapies in Portugal. You will craft high-quality, balanced medical information for healthcare professionals and patients, manage inquiry channels and digital medical content, and support timely, compliant regulatory submissions and labeling updates. Collaborating with cross-functional teams and Health Authorities, you will help translate evidence into practice and ensure our products are used appropriately and safely. The role reports to the Pharmaceutical Affairs Lead within the Medical & Regulatory Department and is based in Barcarena.

Accountabilities
* Medical information excellence: Develop, review, and maintain scientifically robust response documents, FAQs, and materials that align with global core data and local labeling; manage HCP and patient inquiries through approved channels and escalate complex questions as appropriate.
* Stakeholder support: Provide medical information to internal and external partners by presenting data and insights; ensure consistency, accuracy, and compliance with AstraZeneca standards and procedures.
* Continuous knowledge updating: Keep product, therapy area, and guideline knowledge current; monitor recent developments to maintain high-quality, evidence-based communications.
* Digital channels and innovation: Manage medical communication across digital and social media channels; drive innovative digital projects that enhance reach, usability, and compliance of medical information.
* Regulatory activities and submissions: Execute Regulatory Affairs activities for AstraZeneca products in alignment with INFARMED and EMA requirements; support the Regulatory Affairs team to meet submission timelines and quality expectations.
* Local labeling and artwork: Participate in the implementation of local labeling (SmPC, PIL, packaging), including artwork review; ensure accurate translation and timely rollout.
* Cross-functional collaboration: Work closely with national and international AZ teams, external partners, and Health Authorities to enable compliant access and support safe, effective product use.
* Process and compliance improvement: Review resourcing methods and procedures for adequacy and compliance; contribute to continuous improvement across medical information and regulatory processes.

Essential Skills/Experience
* Education: PhD or Master's degree in Pharmaceutical Sciences or Life Sciences.
* Experience: 2+ years in the pharmaceutical industry (medical/scientific/regulatory) or healthcare environment in similar roles.
* Languages: Very good written and verbal communication skills in English and Portuguese.
* Regulatory familiarity: Understanding of national health information systems and the Portuguese regulatory environment; experience aligning with INFARMED/EMA requirements.
* Digital and innovation mindset: Knowledgeable and curious about innovation trends and digital health best practices and solutions; experience managing medical communication in digital channels.
* Collaboration and stakeholder management: Proven ability to work cross-functionally and manage diverse internal and external stakeholders.
* Execution excellence: Strong attention to detail, organizational skills, and time management; ability to learn new skills across product lifecycle and role domains.

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office, while balancing flexibility where it makes sense. Join us in our unique and ambitious world.

AstraZeneca offers a dynamic environment where you can be at the forefront of healthcare innovation. With opportunities for growth and development, we leverage our position as medical leaders to shape the future of healthcare. Our collaborative approach ensures we make a meaningful impact on patients' lives while supporting your personal growth.

Ready to make a difference? Apply now to join our thriving team in Barcarena.

Date Posted08-Jan-2026

Closing Date21-Jan-2026

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements