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Senior Specialist CMC (Regulatory Affairs)

Randstad PolskaWarszawa, Polska

30+ days ago

Job description

For our Client, one of the largest pharmaceutical companies in the world, we are looking for a talented and motivated ( Senior) Regulatory Affairs Specialist to join CMC team and be responsible for supporting global CMC regulatory strategies and documentation.

If you are at the beginning of your career path or are already an experienced Regulatory Affairs professional and want to continue your career at CMC then you have come to a good offer!

Apply, we'd really like to meet you!

what we offer

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 to promote a healthy lifestyle,
annual bonus recognizing your contributions and achievements,
beneficial leave policies to support your personal and professional needs.

your tasks

regulatory strategy : support the implementation of global CMC regulatory strategies and dossier plans for development compounds and marketed products in collaboration with other CMC RA personnel,

Health Authority interactions : support in preparing responses to health authority questions and handling inspections,

documentation : support in the preparation of CMC documentation for submissions to health authorities (NDA / BLA / MAA / IND / CTA and post-approval variations), including country-specific documents,

project management : support in managing global marketing approval submission plans, including timelines and compliance with local requirements,

lifecycle management : support in managing registration processes, ensuring regulatory compliance, and managing the product lifecycle.

what we expect

first experience in CMC, other regulatory affairs area or other position in pharmaceutical / medical industry and motivation to gain experience in regulatory affairs,

educational background (university degree in Life Sciences, Pharmacy etc.),

fluency in English (C1),

strategic thinking and problem-solving abilities,

commitment to integrity and ethical conduct,

proficient understanding of biology, chemistry, and / or engineering relevant to the therapeutic area,

general knowledge of worldwide health authority laws, regulations, and guidance,

knowledge of internal procedures for submitting to health authorities.

Employment agency entry number 47

this job offer is intended for people over 18 years of age

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Regulatory Specialist • Warszawa, Polska