A leading American biopharmaceutical multinational is seeking a Regulatory Affairs Specialist for a 12‑month temporary assignment. The selected candidate will support regulatory activities for marketed products and assist with the preparation and maintenance of regulatory documentation for national and European procedures.
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Our client is a Global Biopharmaceutical Company, leader in the Industry.
Description
Prepare, review, and submit regulatory documentation (variations, renewals, PSURs, RMPs, etc.).
Maintain and update regulatory dossiers in compliance with EU and local requirements.
Collaborate with global and local cross‑functional teams (Quality, Supply, Medical, Legal).
Monitor the progress of submissions with regulatory authorities.
Provide regulatory review and approval of promotional and non‑promotional materials.
Support internal and external audits related to Regulatory Affairs.
Profile
A successful Regulatory Specialist should have:
University degree in Life Sciences (Pharmacy, Biology, Chemistry, or related field).
Previous experience in Regulatory Affairs within the pharmaceutical or biopharmaceutical industry.
Solid working knowledge of EU (EMA) and national (AEMPS) regulatory frameworks.
High level of English (international environment).
Strong organizational, communication, and detail‑orientation skills.
Ability to work effectively within multinational teams.
Job Offer
12‑month temporary contract.
Opportunity to join a top-tier American biopharma multinational.
Competitive salary: €35,000 - €45,000 gross/year, depending on experience.
Hybrid working model and international exposure.
Immediate start
A leading American biopharmaceutical multinational is seeking a Regulatory Affairs Specialist for a 12‑month temporary assignment. The selected candidate will support regulatory activities for marketed products and assist with the preparation and maintenance of regulatory documentation for national and European procedures.
Client Details
Our client is a Global Biopharmaceutical Company, leader in the Industry.
Description
Prepare, review, and submit regulatory documentation (variations, renewals, PSURs, RMPs, etc.).
Maintain and update regulatory dossiers in compliance with EU and local requirements.
Collaborate with global and local cross‑functional teams (Quality, Supply, Medical, Legal).
Monitor the progress of submissions with regulatory authorities.
Provide regulatory review and approval of promotional and non‑promotional materials.
Support internal and external audits related to Regulatory Affairs.
Profile
A successful Regulatory Specialist should have:
University degree in Life Sciences (Pharmacy, Biology, Chemistry, or related field).
Previous experience in Regulatory Affairs within the pharmaceutical or biopharmaceutical industry.
Solid working knowledge of EU (EMA) and national (AEMPS) regulatory frameworks.
High level of English (international environment).
Strong organizational, communication, and detail‑orientation skills.
Ability to work effectively within multinational teams.
Job Offer
12‑month temporary contract.
Opportunity to join a top-tier American biopharma multinational.
Competitive salary: €35,000 - €45,000 gross/year, depending on experience.
Hybrid working model and international exposure.
Immediate start
Desired Skills and Experience
University degree in Life Sciences (Pharmacy, Biology, Chemistry, or related field).
Previous experience in Regulatory Affairs within the pharmaceutical or biopharmaceutical industry.
Solid working knowledge of EU (EMA) and national (AEMPS) regulatory frameworks.
High level of English (international environment).
Strong organizational, communication, and detail‑orientation skills. xpzdshu
Ability to work effectively within multinational teams.
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