Regulatory Contractor

Barrington James; Alicante; A distancia; EUR 60.000 - 80.000; Jornada completa

Descripción de la vacante

A leading recruitment firm is seeking a Regulatory Affairs Contractor for a 6-month full-time contract. The role involves supporting EU regulatory development strategies, preparing CTAs, and engaging with regulatory authorities. Applicants should have over 7 years of experience in Regulatory Affairs within the pharmaceutical or biotech industry, particularly with EU CTAs and MAA submissions. The position requires candidates to be based in Poland or Spain.

Formación

• 7+ years of experience in Regulatory Affairs in the pharmaceutical or biotech industry.
• Hands-on experience with EU CTAs and CTIS, including initial applications.
• Prior experience with MAA submissions, scientific advice, and PIPs.

Responsabilidades

• Support EU regulatory development strategies for key pipeline programs.
• Prepare, submit, and manage CTAs applications via CTIS.
• Assist in the development and submission of Paediatric Investigational Plans.

Conocimientos

Regulatory Affairs experience

EU CTAs knowledge

MAA submissions experience

Scientific advice knowledge

Ability to interpret EU regulatory guidelines

Descripción del empleo

Regulatory Affairs Contractor
Must be based in Poland or Spain!

Opportunity to contribute to high-impact regulatory submissions in a dynamic, collaborative setting (6 month full-time contract).

Key Responsibilities :

• Support EU regulatory development strategies and execution for key pipeline programs.
• Prepare, submit, and manage CTAs applications via CTIS and contribute to the preparation of initial MAAs.
• Assist in the development and submission of Paediatric Investigational Plans (PIPs) and full waiver requests.
• Prepare for and participate in EMA and national Health Authority meetings, including Scientific Advice and regulatory briefings.
• Monitor and interpret evolving EU regulatory guidelines relevant to ongoing studies and development plans.

Key Requirements :

• 7+ years of Regulatory Affairs experience in the pharmaceutical or biotech industry.
• Hands-on experience with EU CTAs, CTIS, including submitting initial applications and maintenance.
• Prior experience with MAA submissions, scientific advice, and PIPs.
• EU regulatory experience essential, US desirable.
• Experience working in or supporting small biotech, pharma, or CRO environments and exposure to global team environments.