Senior Regulatory Specialist - Global CMC Submissions

GSK; Województwo mazowieckie; Hybrid; PLN 211,000 - 296,000; Full time

Job summary

A leading global healthcare company in Poland is seeking a Senior Regulatory Specialist to deliver high-quality CMC dossiers and ensure regulatory compliance. The role involves collaboration with cross-functional teams and requires a Bachelor's degree along with at least 3 years of experience in CMC. The position offers a hybrid work model and an attractive benefits package, including life insurance and private medical care.

Benefits

Annual bonus

Life insurance

Private medical package

Sports cards (Multisport)

Flexible working solutions

Qualifications

• Minimum of 3 years of experience in CMC.
• Confident in executing dossier strategies.
• Ability to identify and escalate issues effectively.

Responsibilities

• Deliver regulatory submissions and ensure compliance.
• Collaborate with cross-functional teams.
• Act as subject matter expert and mentor new staff.

Skills

Independently manages multiple projects

Strong organizational skills

Excellent communication skills

Understanding of global regulatory guidelines

Education

Bachelor's degree in Chemistry, Pharmacy, or related field

Job description

A leading global healthcare company in Poland is seeking a Senior Regulatory Specialist to deliver high-quality CMC dossiers and ensure regulatory compliance. The role involves collaboration with cross-functional teams and requires a Bachelor's degree along with at least 3 years of experience in CMC. The position offers a hybrid work model and an attractive benefits package, including life insurance and private medical care.