Senior Specialist, Regulatory Strategy

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.

Responsibilities

• 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
• Captures review and revision procedures, specifications, and forms
• Coordinates the review and revision procedures, specifications, and forms
• 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

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
• Able 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
• Able 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

Qualifications

• 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

Skills

• Understanding key business drivers
• Understanding processes, procedures and systems used to accomplish the work
• Proficiency with tools and processes that support work conducted by functional area
• Teamwork and training ability
• Computer skills
• Communication, problem-solving, analytical thinking skills
• Attention to detail
• Project management skills
• Regulatory document understanding
• Familiarity with FDA regulations and ICH guidelines
• Laws, regulations, standards, and guidance governing drug development
• Knowledge of US FDA and Ex-US ICH drug development regulatory guidelines

Benefits

• Annual base salary range: $103,300.00 - $141,000.00
• Annual bonus with a target of 20% of the earned base salary
• Eligibility to participate in our equity based long term incentive program
• Retirement savings plan (with company match)
• Paid vacation, holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans