Manager of Regulatory Compliance
2 tygodni temu
We are seeking a highly skilled Regulatory Affairs Manager to join our team in Warsaw, Poland. As a key member of our Established Products team, you will be responsible for providing regulatory support to our Portfolio Leader.
The successful candidate will have significant industry experience in regulatory affairs, excellent communication skills, and a strong understanding of drug development. If you have a passion for regulatory compliance and want to make a tangible impact on regulatory processes and product development, we encourage you to apply.
Responsibilities:
- Strategic Planning: Develop and implement regulatory strategies to ensure compliance with global regulations.
- Collaboration: Work closely with cross-functional teams to provide regulatory expertise and support.
- Communication: Prepare and present regulatory documents, including IND, NDA, CTA, and CTD dossiers.
- Regulatory Submissions: Ensure timely and compliant regulatory submissions, including lifecycle submissions.
Requirements:
- A minimum of a Bachelor's degree in a relevant health-related scientific discipline is required.
- An advanced degree (MS, MD, PhD or PharmD) is preferred.
- Significant industry experience in regulatory affairs is preferred.
- Knowledge of drug development and the regulatory submission and approval process is essential.
- Excellent verbal and written communication skills are required, as well as the ability to work successfully within a collaborative, cross-functional team environment.
- The ability to prioritize effectively assignments for multiple products and projects is also essential.
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