Transpire BIO Inc.
Regulatory Affairs Associate/Manager
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Position Summary
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, ability to write Common Technical Documents (CTD) documents 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
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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, Module 2 and Module 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.
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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’s from ICH, EMA, FDA, MHRA and other global health authorities.
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Regulatory Strategy Support: Assist in the development and implementation of regulatory strategies for product development and approval.
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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 in order to meet scheduling timelines and/or in resolving technical issues.
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Regulatory File Maintenance: Maintain and organize regulatory files and databases, ensuring all documents are up-to-date and easily accessible.
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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 to regulatory requirements. Evaluate change controls and formulate strategies for correct filing categories, with guidance from manager. Proactively raise major project issues if any to manager for resolution and agreement.
Required Qualifications
Education Requirements:
- Bachelor's Degree: A bachelor's degree in a relevant field such as Life Sciences, Pharmacy, Chemistry, or a related discipline is required.
Work Experience Requirements:
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- 5 years or more experience in inhalation drug delivery (pMDI, DPI, SMI) in technical CMC role or regulatory affairs (technical) role
Skills and Abilities
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Ability to summarize complex technical documents into submission CTD documents that meet regulatory agency expectations.
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Ability to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects
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Excellent organization and time management skills and ability to multi-task in a high-volume environment with shifting priorities
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Excellent written and verbal communication skills and interpersonal skills.
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Ability to communicate effectively and collaboratively as part of a team in a respectful manner.
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Ability to work independently, self-starter.
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Good problem-solving skills and analytical ability.
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Ability to work with professionals domestically and abroad.
Specialized Knowledge
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Working knowledge and experience with applicable regulations 21 CFR, US FDA guidelines, ICH guidelines, EMA guidelines and MHRA guidelines.
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Technical working knowledge of inhalation dosage forms (pMDI, DPI, SMI).
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Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Adobe Acrobat Professional is a must.
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, get exposure to various functions with opportunities for career development and work in a collaborative and supportive work environment.
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