Regulatory Affairs Director
2 tygodni temu
**Regulatory Affairs Manager Position**
We are looking for a skilled Regulatory Affairs Manager to lead our team in delivering high-quality submissions and ensuring compliance with country-specific regulatory requirements.
Key Responsibilities:
- Manage the hub site to deliver timely, high-quality submissions.
- Serve as the main contact for client regional leads.
- Implement and maintain compliance with country-specific regulatory requirements.
- Develop and 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.
- Closely monitor and address project audit findings within agreed timelines.
- Oversee training record compliance.
Requirements:
- Bachelor's or Master's degree in life sciences or pharmacy.
- Significant 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).
- At least 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:
- A comprehensive benefits package.
- An open-minded and multinational work environment.
- The opportunity to be part of a global organization focused on development.
- Professional development and a clear career path.
- Training & development opportunities, including language courses.
Check out other job opportunities at: https://en.antal.pl/candidates
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