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 for the market. Ensure conformance to eCTD technical specifications and study‑data technical conformance. Author CTD sections in Modules 1, 2, and 3 from technical documents. Maintain full awareness of all assigned regulatory activities and ensure that project deadlines and performance standards are met. Participate in deficiency review and response generation.
Regulatory Compliance
Ensure submissions meet local market requirements to avoid any Refuse‑to‑Receive (RTR), validation failures, and deficiencies. Review includes a critical detailed assessment that technical documentation and information is available, accurate and complete for submission against relevant regulatory guidance from ICH, EMA, FDA, MHRA, and other global health authorities.
Regulatory Strategy Support
Assist in the development and implementation of regulatory strategies for product development and approval.
Cross‑Functional Collaboration
Work closely with other departments, including R&D, Quality Assurance, Clinical Development, Operations, and external vendors to gather necessary information for regulatory submissions. Represent regulatory affairs in project team meetings and provide regulatory guidance and perspective to team members in determining appropriate actions to meet scheduling timelines and resolve technical issues.
Regulatory File Maintenance
Maintain and organize regulatory files and databases, ensuring all documents are up‑to‑date and easily accessible.
Regulatory Life Cycle Management
Prepare, compile, and submit post‑approval documents including CMC changes, annual reports, variations, and license renewals, ensuring all products maintain regulatory compliance. Evaluate change controls and formulate strategies for correct filing categories, with guidance from management. Proactively raise major project issues to management for resolution and agreement.
Required Qualifications
Education Requirements:
• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, or a related discipline is required.
Work Experience Requirements:
• 5+ years of experience in inhalation drug delivery (pMDI, DPI, SMI) in a technical CMC role or regulatory affairs (technical) role.
Skills and Abilities:
- Summarize complex technical documents into submission CTD documents that meet regulatory agency expectations.
- Maintain a high level of accuracy and attention to detail while meeting deadlines for assigned projects.
- Excellent organization and time‑management skills, able to multi‑task in a high‑volume environment with shifting priorities.
- Excellent written and verbal communication skills and interpersonal skills.
- Communicate effectively and collaboratively as part of a team.
- Work independently, self‑starter.
- Good problem‑solving skills and analytical ability.
- Work with professionals domestically and abroad.
Specialized Knowledge:
- Working knowledge of regulations such as 21 CFR, US FDA guidelines, ICH guidelines, EMA guidelines, and MHRA guidelines.
- Technical working knowledge of inhalation dosage forms (pMDI, DPI, SMI).
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and Adobe Acrobat Pro.
Why Join Us?
We are a fast‑growing pharmaceutical startup dedicated to innovation and improving patient outcomes. Join us to gain hands‑on experience in a growing pharmaceutical business, gain exposure to various functions with opportunities for career development, and work in a collaborative and supportive environment.
