Responsibilities
- Oversees regional regulatory leads and staff responsible for ensuring global/regional regulatory strategies are written, reviewed, and executed according to plan
- Provides strategic and tactical advice and guidance to allow the timely and efficient conduct of all regulatory projects
- Ensures compliance for global regulatory requirements
- Is a leader, contributing to cross-functional initiatives and influencing as applicable and demonstrating leadership behaviors
- Directs and oversees multiple projects (inclusive of highly complex ones), generally has global/regional oversight for assigned products, this includes oversight to ensure regulatory compliance (e.g. on registration database) by staff and / or vendor
- Oversees and accountable for working with other RA functions and/or vendor to ensure that regulatory submissions and approvals are achieved on schedule within area of responsibility
- Understands importance of regulatory documents for value and access discussions and partners with access functions to support access applications
- Provides leadership and development for direct reports, including those that serve as regional regulatory leads responsible for the design and execution of regional regulatory strategies
- Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner
- Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions
- Accountable for all global submissions and approvals of project(s) and/or oversees direct reports responsible
- Oversees all submissions
- Leads and manages meetings and / or interactions with regulatory authorities and agency meetings; or delegates and oversees direct reports and / or vendor; negotiates on behalf of RA team, as necessary
- Accountable for working with regulatory regional leads, other functions, and vendors to ensure global regulatory submissions are provided in compliance with local regulations. And to maintain compliance for products
- Oversee vendor responsibility for regulatory activities and submissions related to projects within scope
- Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner
Requirements
- MD, PhD or PharmD in a scientific discipline
- 15+ years of experience in Regulatory Affairs
- proven success in regulatory submissions
- sound knowledge of such principles as GxP's, FDA, and EU guidelines
- experience with investigational drugs, including late stage development, and marketed products
- prior managerial experience, with direct supervision of mid- to senior-level regulatory professionals
- strong leader that creates a vision for group
- inspires and motivates group
- takes stand on important issues in productive, respectful way
- able to mentor and develop skills of staff
- strong overall and able to train/develop staff in the area of regulatory strategy
- strategic thinker, planner, and implementer with excellent organizational skills
- excellent oral and written communication skills
- able to plan and execute regulatory projects, and proven record of delivering results within business-defined timeframes
- proven ability to work on complex problems where analysis of the situation or data requires an evaluation of intangible variables
- demonstrates potential for a high level of collaboration with others and within global teams
- independent thought, negotiation skills, integrity, and adaptability
- ability to work on own and in virtual setting
- MS Office skills with excellent use of excel, PowerPoint and MS Project
Nice to Have
- FDA, EU, Canada, ROW, and post-marketing experience
- experience in attending and leading a team to prepare for major health authority interactions
- CRO management experience
- recent experience with a smaller entrepreneurial environment
Benefits
- competitive compensation package
- annual bonus based on company performance
- Incentive compensation program
- car reimbursement program and gas card
- comprehensive health coverage
- hybrid work model
- Retirement Savings Plan (401K)
- generous time off policy
- extra week off between Christmas and New Year’s
- 13 holidays
- tuition reimbursement
- Azurity High Five peer recognition platform
Additional Information
- Must be able to sit for long periods of time
- While performing the duties of this job, the employee is frequently required to stand; walk; sit; talk and/or hear
- May occasionally climb stairs and/or ride elevators
- The employee must occasionally lift and/or move up to 25 pounds
- Employee must be able to manipulate keyboard, operate a telephone and hand-held devices
- Fluent in English (written and oral)
