Regulatory Affairs Director
3 days ago
We are seeking a highly skilled Regulatory Affairs Director to lead our Global Therapeutic Area (TA) Regulatory Affairs team in Virology. As a key member of our team, you will be responsible for defining the regulatory strategy, plans, and objectives for assigned products or projects. You will also oversee the preparation and maintenance of regulatory submissions, labeling, and packaging for assigned products or projects.
The ideal candidate will have a strong background in regulatory affairs, with experience in leading cross-functional teams and representing Gilead in negotiations with regulatory authorities. You will be responsible for ensuring compliance with regulatory requirements and developing strategies to mitigate risks and issues.
Key Responsibilities
- Define the regulatory strategy, plans, and objectives for assigned products or projects
- Oversee the preparation and maintenance of regulatory submissions, labeling, and packaging for assigned products or projects
- Lead cross-functional teams and represent Gilead in negotiations with regulatory authorities
- Ensure compliance with regulatory requirements and develop strategies to mitigate risks and issues
Requirements
- BA/BS or advanced degree in life sciences or related field
- Significant regulatory experience in the biopharma industry, regulatory agency, clinical research, or other related healthcare environment
- Experience leading cross-functional teams and representing companies in negotiations with regulatory authorities
- Strong knowledge of European Medicines Agency (EMA) regulatory requirements and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) standards
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