Regulatory Affairs Professional
2 days ago
At X4 Life Sciences, we are seeking a highly skilled Regulatory Affairs Specialist to oversee the entire lifecycle of Marketing Authorizations (MAs). This includes maintaining all aspects of MA maintenance, preparing and publishing documentation for Common Technical Documents (CTDs), implementing and communicating MA changes, collaborating with internal teams and external stakeholders, creating patient information leaflets, and managing regulatory files.
Responsibilities:- Maintain comprehensive knowledge of regulatory requirements and guidelines to ensure compliance with changing regulations.
- Develop and implement effective strategies to maintain and improve the company's MA portfolio.
- Prepare and submit high-quality CTD dossiers to regulatory authorities in a timely manner.
- Collaborate with cross-functional teams to develop and implement product labeling, packaging, and artwork.
- Liaise with clients, partners, and regulatory authorities to ensure seamless communication and efficient resolution of issues.
- Maintain accurate and up-to-date records of MA documents, submissions, and approvals.
- Bachelor's degree in sciences, engineering, medical/scientific writing, or public health administration.
- At least 2 years of experience in Regulatory Affairs or a related field.
- Proven track record of preparing technical documentation for regulatory submissions.
- Excellent written and verbal communication skills, with the ability to interact effectively with diverse stakeholders.
- Ability to work independently and manage daily regulatory responsibilities for a product portfolio.
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