Regulatory Affairs Specialist (Location - Carregado) Alenquer

Overview

Regulatory Affairs Specialist (Location - Carregado)

SOMAÍ is a leading EU-GMP European vertically integrated Multi-Country Operator (MCO) company with a global footprint of distribution for the largest and most advanced EU GMP-certified
- containing pharmaceutical extract portfolio. SOMAÍ owns a
-
-
- art manufacturing facility and indoor cultivation in Lisbon, Portugal, and has global sales teams in the largest medical cannabis markets. We are continuing to make acquisitions and global brand partnerships that make us one of a few and the first European-based vertically integrated companies in the EU able to cater to the diverse needs of
- growing global cannabis markets.

We are looking for a Regulatory Affairs Specialist to join our team. The professional will be responsible for ensuring the regulatory compliance of products and processes, guaranteeing that all activities meet the applicable legal, technical, and scientific requirements.

Responsibilities

• Prepare, submit and follow up on regulatory submissions to national and international authorities;
• Prepare and review technical and scientific documentation required for product registrations, renewals and variations;
• Support the authorization and commercialization process of new products, ensuring compliance with legal timelines;
• Review and approve labelling texts, packaging, leaflets and promotional materials in line with applicable legislation;
• Contribute to product safety monitoring on the market, participating in pharmacovigilance activities;
• Maintain
  -
  - date regulatory files and manage the corresponding archive;
• Provide technical regulatory support to other departments (Quality, R&D, Production, Marketing, etc. );
• Develop internal regulatory strategies and procedures in compliance with current legislation;
• Ensure effective communication with regulatory authorities, partners, and internal departments on regulatory matters.

Qualifications

• Degree or Integrated Master’s in Pharmaceutical Sciences, or degree in health and
  - related sciences (Biology, Biochemistry, Chemistry);
• Strong focus on quality, compliance and meeting deadlines;
• Problem-solving orientation and ability to work effectively in a team.
• Driver's license (preferred)
• Available immediately (preferred)

If you meet the requirements above, join us and help us build the future!

Please send your application to the following email address:

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Legal

Industries

• Pharmaceutical Manufacturing

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