Regulatory Specialist, CMC Variations
Poznan, WarszawaRegulatory Specialist, CMC Variations
Poznan, Warszawa
NR REF.: 1150106
The structures of our client are growing and we are currently looking for several successful candidates for the position of Regulatory Specialist CMC Variations
Key responsibilities:
Basic qualifications:
We offer:
Poznan, Warszawa
NR REF.: 1150106
The structures of our client are growing and we are currently looking for several successful candidates for the position of Regulatory Specialist CMC Variations
Key responsibilities:
- Managing multiple CMC (Chemistry, Manufacturing and Control) Variations assignments for Finished Products and Active Pharmaceutical Ingredients for Pharma and Vaccines products
- Define and agree strategy, complete data assessment to ensure authored regulatory dossier is in compliance with the company regulatory processes and external requirements for local markets e.g. Europe (for Centralised, Mutual Recognition and Decentralised procedure submissions, US and International countries)
- Working with colleagues in Global Manufacturing & Supply and company Local Operating Companies in markets worldwide to deliver high quality dossier on time
- Monitoring regulatory intelligence and act proactively on identified changes to regulatory requirements
- Building good relationships with internal and external stakeholders
- Ensuring all appropriate regulatory aspects for product release and stability are in place, to ensure continuity of market supply
Basic qualifications:
- Relevant experience (in regulatory affairs, pharmaceutical industry, life sciences research, clinical research, pharmacovigilance)
- Bachelor’s or Master's degree in biotechnology, pharmacy, chemistry or other related science or technical field
- Previous experience with eCTD/CTD documentation is preferred
- Attention to detail, excellent organization and time management skills
- Excellent written and verbal communication skills in English and Polish
- Ability to think flexibly to meet constantly shifting priorities and timelines and to independently provide solutions to issues
- Understanding of the pharmaceutical industry, drug development environment, and regulatory processes.
We offer:
- Established job in an international, well-known pharmaceutical company
- Opportunity to work in professional team playing crucial role in introducing the company’s portfolio to the market
- Opportunity to work within the company standards and documentation applied globally
- Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards)
- Flexible working hours
- Remote work
Prosimy o aplikowanie poprzez przycisk znajdujący się po prawej stronie ogłoszenia.
