Regulatory Affairs Expert

7 dni temu


Warszawa, Mazovia, Polska Randstad Polska Sp. z o.o. Pełny etat

Our Client, a leading pharmaceutical company, is seeking a talented and motivated Senior Regulatory Affairs Specialist to join their CMC team. As a key member of the team, you will be responsible for supporting global CMC regulatory strategies and documentation.

The ideal candidate will have first-hand experience in CMC, regulatory affairs, or a related field, with a strong educational background in Life Sciences, Pharmacy, or a related discipline. Fluency in English (C1) is a must, and strategic thinking and problem-solving abilities are highly valued.

You will work closely with other CMC RA personnel to implement global CMC regulatory strategies and dossier plans for development compounds and marketed products. This includes preparing responses to health authority questions, handling inspections, and managing global marketing approval submission plans.

In addition to your technical expertise, you will possess a commitment to integrity and ethical conduct, as well as a proficient understanding of biology, chemistry, and/or engineering relevant to the therapeutic area.

We offer a comprehensive package of benefits, including a hybrid model of work for flexibility and convenience, comprehensive private medical care and life insurance for you and your family, a robust company pension plan to secure your future, reimbursement for sports activities and access to well-being programs, and an annual bonus recognizing your contributions and achievements.



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