We're hiring | Junior Regulatory Affairs Officer
STADA Portugal | Hybrid working model
Fixed-term contract – Maternity leave replacement
Do you want to be part of a fast-paced business growth journey?
It's an exciting time at STADA and as a global health care group with ambitious growth plans, we dedicate ourselves to providing solutions to people's health and wellbeing. With a long-standing heritage and leading manufacturer of pharmaceutical and healthcare products rooted in pharmacies, we continue to support the delivery of our strategic vision of Caring for People's Health as a Trusted Partner.
Role Purpose:
You will manage all aspects of regulatory affairs activities in the local affiliate, related to medicinal products, food supplements, medical devices and cosmetics. Key focus will be given to:
* Management of National Procedure, Decentralised, MRP, and Centralised Procedures: preparation, submission, monitoring and implementation of new applications, and pre & post-MA activities.
* Revision of artwork
* Revision of promotional materials
* Assure articulation with Global Regulatory Teams
* Assure articulation with relevant stakeholders
* Supporting internal database systems (Regulatory Information Management, Documentation Management, Change Control)
* Close contact with Portuguese Competent Authority for timely approvals.
About you:
At STADA we talk about diversity as Uniqueness. Everyone is unique and we recognise our differences as a strength. Our values Entrepreneurship, Integrity, Agility and One STADA ensure our uniqueness thrives, enabling us to care for people's health as a trusted partner. Empower your Uniqueness, bring your whole self to STADA.
If you're keen to add value and see results, enjoy working in a fast-paced environment, enjoy working with teams across the business and have the can-do spirit that's spearheading our success, bring those unique qualities, with the following experience:
* Master's degree in pharmacy or equivalent and at least 1 years of regulatory experience is required.
* Adequate English written and oral communication skills
* Ability to work under pressure and to strict deadlines
* Excellent communication skills to enable collaborative working with cross functional internal stakeholders such as Supply and Commercial functions
* Knowledge in pharmacovigilance is a plus
If you think that you meet these requirements and want to share your experience with us, please apply now.