Sr. Specialist/Associate Manager, Regulatory Affairs - Cell Therapy

Adherence to AZ and industry code of conduct, ethics and good regulatory practices including AZC RA SOPs and other required SOPs.

Align with the values and vision of AZ

Maintain regulatory compliance (PI & CMC) with Local legislation, Global regulatory policies, AZ code of conduct

Maintain company confidentiality ( intellectual property, product information and strategic information)

Disclose potential breach of codes or conduct

Follow SOP requirements especially on documentation

For allocated portfolio develop and action regulatory strategies to achieve rapid and high-quality approval and facilitate rapid launch.

Maintain detailed knowledge of critical aspects of products: commercial strategies, content of the dossiers, regulatory intelligence, regulatory timeline, supply strategy

Assist in ensuring local regulatory strategies are consistent with global product strategies and local priorities

Develop regulatory plan...