Job Description
The Regulatory Affairs Associate/Manager will support the regulatory team in ensuring adherence to all applicable regulations and guidelines related to inhalation pharmaceutical products development and the filing of marketing authorization applications such as ANDAs to the FDA, and MAAs to UK and EU Agencies. This role involves preparing regulatory documents and marketing application filings, primarily at an operational level. The ideal candidate will be strongly detail oriented, able to write Common Technical Documents (CTD), and have strong organizational skills.
This role is ideal for a candidate who has extensive technical CMC authoring experience in inhalation product development and wishes to transition to a role in regulatory affairs.
Essential Duties and Responsibilities
Document Preparation: Generate high‑quality marketing authorization applications (NDAs and ANDAs in the US, and MAAs in the UK/EU) that meet regulatory guidance f...