Senior Specialist CMC, Randstad

Randstad

Location:

Poland, Warszawa

Category:

Health and Beauty

Contract Type:

Employment contract

Salary:

Not provided

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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.

Job Responsibility:

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

Requirements:

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

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

Additional Information:

Job Posted:

March 31, 2025

Expiration:

April 22, 2025

Employment Type:

Fulltime

Work Type:

Hybrid work

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