US Regulatory Affairs Professional
1 day ago
We are seeking a highly skilled Regulatory Affairs professional to support our team in the US market.
- Key Responsibilities:
- Prepare and review regulatory submissions, including ANDAs, NDAs, supplements, amendments, deficiency responses, annual reports, and PADER in eCTD format.
- Maintain compliance with US FDA and ICH requirements, including post-approval regulatory filing deadlines.
- Author and review high-quality CMC documentation, Module 3, and Module 2.3 Quality Overall Summary (QoS).
- Manage and update labelling components; evaluate and approve changes to approved products for regulatory impact.
- Review technical documents such as specifications, analytical procedures, batch records, method validation reports, and stability data.
- Support regulatory strategy by identifying critical issues, responding to FDA queries, and ensuring timely submission of responses.
- Review and approve change controls from global manufacturing partners to assess regulatory impact.
- Stay current with FDA guidance, ICH regulations, pharmacopoeial requirements, and industry updates.
Requirements:
- Bachelor's/Master's degree in Pharmacy, Life Sciences, or related field.
- 3 to 7 years of experience in Regulatory Affairs, preferably with US FDA submissions.
- Strong knowledge of eCTD submissions, CMC requirements, and US labeling.
- Excellent oral and written communication skills.
- Ability to work independently and in a team environment.
- Proficiency in Microsoft Office Suite with Microsoft Word and Excel.
- Detail-oriented, with excellent communication and cross-functional collaboration skills.
This opportunity offers the chance to contribute to the success of our clients and advance your career in Regulatory Affairs.
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