Regulatory Affairs Specialist
Há 15 horas
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.
- 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.
- Develop and implement global CMC strategies to support Site of Source Changes for assigned small molecule products.
- Prepare and review regulatory CMC dossiers for MSA network changes with health authorities.
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements and company procedures.
- Manage execution of CMC documentation, including post-approval supplements and responses to health authority questions.
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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