About the Role:Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections. Compiles all materials required in submissions, license renewal and annual registrations. Generates, maintains, monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. Maintains and tracks timelines for regulatory deliverables. Recommends strategies for earliest possible approvals of clinical trials applications. May act as Regulatory Strategy department contact for various internal projects or program activities.
Your Contributions (include, but are not limited to):- Performs the preparation of submissions to regulatory authorities (e.g. clinical trial applications, IND/IND supporting documents and maintenance submissions, annual reports, expedited safety reports)
- Conducts reviews of clinical regulatory documents. Performs quality checks of submission documentation and publishing output
- Updates and maintains logs, databases and catalogues of regulatory compliance information
- Coordinates the review and revision procedures, specifications, and forms.
- Compiles regulatory filing documents and maintain computerized files to support all documentation systems
- Serves as Regulatory Strategy department contact for internal company projects or program activities
- Responsible for initiating and maintaining program Smartsheet tools for timeline tracking, submission deliverable tracking and program plans as assigned.
- Ensures quality, consistency, completeness and accuracy for all regulatory submissions
- Review investigator packages and authorize drug shipments to clinical sites
- Performs other job related duties as assigned
Requirements:- BS/BA degree AND 4+ years of relevant experience, or OR
- Master's AND 2+ years of related experience, or OR
- JD or PharmD or PhD AND without experience
- 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
- 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
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The annual base salary we reasonably expect to pay is $103,300.00-$141,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
