Regulatory Affairs Manager/ Delivery Site Lead
ref nr: 298/8/2024/AK
In Antal we have been dealing with recruitment for over 20 years. Thanks to the fact that we operate in 10 specialised divisions, we have an excellent orientation in current industry trends. We precisely determine the specific nature of the job, classifying key skills and necessary qualifications. Our mission is not only to find a candidate whose competences fit the requirements of the given job advertisement, but first and foremost a position which meets the candidate’s expectations. Employment agency registration number: 496.
Regulatory Affairs Manager/ Delivery Site Lead
For the client - one of the largest pharmaceutical companies, we are looking for a Regulatory Affairs Manager to lead teams of Regulatory Specialists in Poland
Responsibilities:
- Lead the hub site to deliver timely, high-quality submissions.
- Serve as the main contact for client regional leads.
- Ensure compliance with country-specific regulatory requirements.
- Establish new processes and documentation.
- Manage team attrition, resources, and budget effectively.
- Proactively address concerns with the Engagement Manager.
- Ensure team compliance with the general training plan and mandatory courses.
- Close project audit findings within agreed timelines.
- Oversee training record compliance.
Requiremets:
- Bachelor’s or Master’s degree in life sciences or pharmacy.
- Experience in Regulatory Affairs for Pharmaceuticals, Biologics, Chemicals, or Medical Devices.
- Familiarity with regulatory publishing tools (eCTDXpress, ISI toolbox, Firstdoc, Insight publisher).
- Experience with US and EU submissions (CTD/eCTD/NeeS).
- 6-10 years in Regulatory Operations and Document Publishing.
- Knowledge of 21 CFR part 11 and Good X Practice (GxP).
- Preferred skills: experience in submission publishing and emerging markets, as well as regulatory affairs certification.
We offer:
- Extensive benefits package: Multisport Card, LuxMed medical healthcare including dental care, life insurance, cafeteria benefits,
- Open-minded and multinational environment,
- Opportunity to be part of a global organization focused on development,
- Professional development and a clear career path,
- Training & development opportunities including language courses.
