Regulatory Affairs Specialist

Há 15 horas


Lisboa, Lisboa, Portugal Biom?Rieux Bv Tempo inteiro
Job Description

We are seeking an experienced Regulatory Affairs Specialist to join our team in a key role within our Regulatory Affairs department. The ideal candidate will have a strong background in Chemistry, Manufacturing and Controls (CMC) and experience in regulatory affairs.

About the Role
  • The successful candidate will be responsible for developing and implementing global CMC strategies to support Site of Source Changes for assigned small molecule products.
  • This includes preparation and review of regulatory CMC dossiers for MSA network changes with health authorities.
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements and company procedures.
Requirements
  • Bachelor's degree in a science, engineering or related field with at least 7 years of relevant experience, including biological/pharmaceutical research, manufacturing, testing or a related field.
  • Advanced degree with at least 4 years of relevant experience is also acceptable.
  • Strong negotiation, interpersonal, written/oral communication and fluency in English language skills are essential.
  • Ability to lead by influence and work effectively in matrix organizational structures.
Key Responsibilities
  1. Develop and implement global CMC strategies to support Site of Source Changes for assigned small molecule products.
  2. Prepare and review regulatory CMC dossiers for MSA network changes with health authorities.
  3. Collaborate with cross-functional teams to ensure compliance with regulatory requirements and company procedures.
  4. Manage execution of CMC documentation, including post-approval supplements and responses to health authority questions.
Competitive Salary and Benefits Package

We offer a highly competitive salary, ranging from $60,000 to $80,000 per year, depending on experience. Additionally, we provide a comprehensive benefits package, including medical, dental and vision insurance, 401(k) plan, paid time off and opportunities for professional growth and development.



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