MA Lifecycle Specialist

2 days ago


St Albans, Hertfordshire, United Kingdom X4 Life Sciences Full time

We are looking for a seasoned Regulatory Affairs Specialist to join our team at X4 Life Sciences. As an essential member of our regulatory department, you will play a critical role in ensuring the successful launch and maintenance of our products. Your expertise will be instrumental in navigating the complexities of regulatory requirements and developing effective strategies to address emerging challenges.

Key Responsibilities:
  • Develop and implement comprehensive regulatory strategies to support product launches and lifecycle management.
  • Prepare and submit high-quality regulatory submissions, including CTD dossiers, to regulatory authorities.
  • Collaborate with cross-functional teams to develop product labeling, packaging, and artwork that meet regulatory requirements.
  • Liaise with clients, partners, and regulatory authorities to ensure effective communication and resolution of issues.
  • Maintain accurate and up-to-date records of regulatory documents, submissions, and approvals.
Essential Qualifications:
  • Bachelor's degree in sciences, engineering, medical/scientific writing, or public health administration.
  • Minimum 2 years of experience in Regulatory Affairs or a related field.
  • Proven expertise in preparing technical documentation for regulatory submissions.
  • Strong 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.

Salary: $80,000 - $110,000 per annum



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