- Job Level:
$125,000 - $150,000 plus Bonus
We are seeking an experienced Regulatory Affairs professional who is ready to make a career-boosting move to a growing US-based team. This Senior Regulatory Associate/Regulatory Manager role will report to the Associate Director of Regulatory Affairs and will be responsible for compiling and responding to eCTD regulatory submissions, leading regulatory projects, evaluating issues and making recommendations to the department and corporate leadership as appropriate.
Our client is a global specialty pharmaceutical with divisions responsible for the development, manufacture, marketing, and distribution of high-quality and affordable pharmaceutical products.
- With minimal supervision the Senior Associate/Regulatory Manager will compile, review and submit high quality, eCTD regulatory submissions supporting generic and new drug development projects (original ANDAs, INDs, NDAs, deficiency responses) to ensure timely submissions to the FDA.
- Interacts effectively with cross-functional business units to coordinate and facilitate documentation required for submissions and managing project timelines to ensure company timeline targets are met.
- Evaluates change control documentation and formulate strategies for correct filing categories with guidance from supervisor.
- Prepares and assists with Drug Listing and SPL submissions.
- Assists in the preparation and review of labeling materials for FDA submission.
- Maintain current working knowledge of existing and pending regulations to ensure compliance with FDA requirements.
- Participates in the development and maintenance of operations systems, processes, checklists and procedures to facilitate consistency.
- BS/MS Regulatory Science, Pharmaceutical Sciences, or Life Science programs.
- RAC certification is highly desirable
Experience & Skills Required
- 3+ year’s relevant pharmaceutical industry experience with demonstrated regulatory affairs experience supporting FDA regulated pharmaceutical products.
- Must have solid experience with pre-approval ANDA activity, including original applications and deficiency responses.
- Prior experience supporting sterile product and ability to act as a subject matter expert in this area
- Working knowledge of CMC, CFR, ICH and FDA guidance is required.
- Desirable experience includes:
- Some post-approval experience is desirable.
- 505(b)(2) experience is a plus
- SPL labeling experience is a plus
- Understanding of pharmaceutical drug development, prior R&D experience is a plus
- Excellent attention to details.
- Excellent verbal and written communication skills.
- Good understanding of regulatory requirements for ANDAs and 505(b)(2) applications.
- Proficiency in Microsoft office and XML programs.
- Ability to manage timelines and priorities, strong multi-tasking ability, and ability to work independently with some guidance.
- Ability to establish and maintain good working relationships.