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Experience HELM as a unique family business and an attractive employer. Through a constant exchange of ideas, our ultimate goal is to offer our customers future-oriented solutions within our global network. At any time, in any place. This allows us to work proactively and think long-term - in operations, quality management, process optimization, product development and distribution. We are innovation drivers, possibility makers and a reliable partner, all in one.

Regulatory Affairs Manager (m/f/d)

Date:  Feb 16, 2026
Location: 

Carnaxide, PT, 2790-045

Business Unit:  Pharma
Job Function:  Product Management
Level of Experience:  Mid-Career

For our office in Carnaxide, HELM Pharmaceuticals is looking for a Regulatory Affairs Manager (m/f/d)

In this position, you ensure, that innovative projects and products receive the regulatory approvals needed to enter the markets. You collaborate closely with internal teams, customers and authorities, creating the foundation for smooth launches and regulatory compliance.

Your tasks:

  • You take responsibility for preparing and managing registration procedures for projects and products, ensuring full compliance with all relevant regulatory guidelines to secure the respective Marketing Authorizations.
  • To prepare the Marketing Authorization application,  you develop and compile complete and high‑quality dossiers and coordinate the response process to deficiency letters issued by the regulatory authorities.
  • Furthermore, you provide comprehensive regulatory support during all launch activities also to ensure a smooth and compliant market introduction.
  • Regular communication with customers who act as current or potential Marketing Authorization Holders forms an important part of your daily work, ensuring transparency and alignment throughout each project.
  • In doing so, you also handle the coordination, communication and negotiation processes with regulatory authorities worldwide to drive timely and successful approvals.

 

Your profile:

  • You hold a master´s degree in Lifescience (e. g. pharmaceutics, biology, chemistry)
  • Having worked in pharmaceutical companies, you already possess of profound knowledge of the pharmaceutical industry.
  • During previous work experiences, you furthermore have gained insights into the structure and working methods of competent health authorities.  
  • Moreover, you have at least three to five years’ experience in regulatory affairs for European and national procedures or other highly regulated markets (e.g., US and Canada).
  • Furthermore, you possess of excellent verbal and written communications skills in English language, ideally also Portuguese and/or German.

Every day, each one of us contributes to HELM's success with competence, the highest expertise and unique service. We reward this commitment - not only with international opportunities, possibilities for seminars and further training but also with benefits that offer optimal conditions to reach the perfect work-life balance.

Interested?

Join our motivated team and help shaping the future of HELM! Even if you do not fulfil all of the requirements in our profile, we encourage you to apply. It is important to us to find the right people who will enrich our team with their motivation and personality!

We look forward to receiving your application with all the necessary documents via our application portal.

Apply now »