Regulatory Affairs Specialist for Life Sciences
1 month ago
We are seeking a skilled Regulatory Affairs Officer to join our team at Lifelancer. The ideal candidate will have hands-on experience with eCTD software, be proficient in Annual report preparation, and possess knowledge of regulatory requirements.
Key Responsibilities:- Facilitate Annual report preparation for various solid oral products
- Review stability data, BPR documentation, and Human prescription drug labelling
- Prepare labelling sections and facilitate section 1.14 module 1 of ANDA dossier creation
- Contribute to Module 32s and 32p preparations
- Possess hands-on experience with eCTD software (PharmaReddy) for SPL generation, registration, sequence creation, and uploading
- Coordinate submissions via ESG
The successful candidate will have:
- Excellent understanding of Regulatory Affairs principles
- Hands-on experience with eCTD software (PharmaReddy)
- Strong analytical and problem-solving skills
- Effective communication and collaboration abilities
Lifelancer is committed to providing a dynamic and supportive work environment. As a Regulatory Affairs Officer, you can expect:
- A competitive salary of $85,000 - $110,000 per year, depending on location and experience
- A comprehensive benefits package
- Ongoing training and professional development opportunities
- A collaborative and inclusive team environment
Join us at Lifelancer and take your career to the next level as a Regulatory Affairs Specialist.
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