Sr. Specialist – Regulatory Strategy
| Company | Neurocrine Biosciences |
|---|---|
| Location | San Diego, CA, USA |
| Salary | $101200 – $146550 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PharmD, PhD, JD |
| Experience Level | Senior |
Requirements
- BS/BA degree and 4+ years of relevant experience OR
- Master’s and 2+ years of related experience OR
- JD or PharmD or PhD and without experience
- Must be able to effectively understand, interpret and apply company standards and regulatory guidance to all documents reviewed
- Strong familiarity with regulatory documents
- Strong familiarity with FDA regulations and ICH guidelines for regulatory submissions
- Thorough understanding of laws, regulations, standards, and guidance governing drug development (e.g., US regulatory knowledge)
- Demonstrated knowledge of US FDA and Ex-US ICH drug development regulatory guidelines to ensure compliance with local and regional requirements, as well as with company policies
- Understands key business drivers and uses this understanding to accomplish work
- Has strong understanding of processes, procedures and systems used to accomplish the work and recognizes downstream impact on other functional areas
- Proficient with tools and processes that support work conducted by functional area
- Ability to work as part of a team; may train lower levels
- Excellent computer skills
- Strong communications, problem-solving, analytical thinking skills
- Detail oriented yet can see broader picture for department
- Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
- Strong project management skills
Responsibilities
- Prepare document packages for regulatory submissions, ensuring compliance with local and regional registration requirements and company policies
- Stay ahead of regulatory changes, maintain tracking systems, and recommend strategies for swift clinical trial approvals
- Act as the go-to contact for internal projects and program activities
- Ensure that all regulatory submissions are of the highest quality, accuracy, and completeness
- Oversee the review and revision procedures, coordinate program activities, and utilize tools like Smartsheet for timeline tracking
- Perform additional duties as assigned
Preferred Qualifications
-
No preferred qualifications provided.