Senior Associate, Regulatory Affairs CMC
New
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Iovance BiotherapeuticsBiotechnology
Location: RemoteFull-TimeSenior
Salary140,000 - 160,000 USD per year
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Job Details
- Experience
- 8 years’ experience in regulatory affairs or a related function in drug/biologic development with a bachelor’s degree, 6+ years’ experience with a master’s degree, or 3+ years with a PhD
- Required Skills
- Microsoft Office
Requirements
- BS degree required; advanced degree (PharmD, PhD, Master’s) preferred.
- Strong scientific or research background in pharmacy, chemistry, or biology.
- 8 years’ experience in regulatory affairs or related function with a bachelor’s degree, 6+ years with a master’s, or 3+ years with a PhD.
- Understanding of US and international drug/biologics development regulations and ICH procedures.
- Familiarity with ICH eCTD structure and post-approval change requirements.
- Advanced skills in Microsoft Office Suite (Word, PowerPoint, Excel) and Adobe Acrobat Pro.
- Excellent written skills with the ability to form defensible arguments based on data and guidelines.
- Strong organizational and planning skills.
- Ability to work both independently and collaboratively in a fast-paced environment.
Responsibilities
- Support the planning, compilation, QC, and submission of CMC dossier content for clinical and commercial applications.
- Prepare and adapt submission documents for global regulatory use following eCTD specifications.
- Independently plan and prepare routine clinical trial application amendments and commercial submissions including DSURs and health authority queries.
- Manage submission trackers and maintain logs of regulatory correspondence.
- Facilitate communication with CROs and vendors to ensure timely delivery of IND, CTA, and EU-CTR submissions.
- Support the implementation of regulatory strategy across all development stages from IND through BLA/NDA approval.
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