Regulatory Affairs Manager (m/f/d)

HELM AG
Full-time Carnaxide, Lisboa Other Management Occupations
Posted:
March 02, 2026
Location:
Carnaxide, Lisboa, Portugal

Job Description

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 mark...
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    Job Overview

    Job Type: Full-time
    Location: Carnaxide, Portugal
    Posted: March 02, 2026
    Deadline: April 11, 2026