Apply now »

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 - HELM Pharmaceuticals (m/f/d)

Date:  Apr 30, 2025
Location: 

Carnaxide, PT, 2790-045

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

A friendly, international team that develops generic pharmaceuticals and makes them ready for market, awaits you at HELM Pharmaceuticals. At our portuguese location, we are looking for a motivated Regulatory Affairs Manager (m/f/d).

 

Your Main Tasks and Objectives:

  • In this position, you will manage HELM´s Regulatory Affairs' activities in line with Company´s policies, procedures and practices, and all legal and customer requirements.
  • Moreover, you are in charge of the timely planning and management of product related regulatory compliance and lifecycle management (according to the company strategy).
  • In addition, the preparation of proposals, the review and management of variations, new submissions and regulatory life cycle strategies in EU, selected RoW countries and growth regions (LATAM, CIS, MENA) are part of your daily tasks.

 

Your profile:

  • Master of Science degree / Life Science (e. g., pharmacy, biology, chemistry, …).
  • Knowledge of pharmaceutical industry with business focused mindset.
  • Knowledge of the structure and working methods of competent health authorities.
  • At least 3 years’ experience in Regulatory Affairs with a focus in CMC and Life Cycle Management.
  • 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?
Then please apply with all necessary documents via our application portal.

Apply now »