The Vice President, Regulatory Affairs drives the development of the global regulatory strategy for Elevar’s products in development and on the market. The VP will provide expert advice to Elevar business units, ensuring compliance with regulatory requirements, overseeing all regulatory submissions and alignment with commercial initiatives. The VP develops and directs a robust regulatory strategy that supports growth opportunities in the commercial business.
2. Job Details
Lead Global Regulatory Affairs and build and lead the regulatory organization.
Provide training and interpretation of FDA and other regulatory issues in clinical development and commercial.
Responsible for Elevar’s compliance with regulatory agencies and all applicable standards worldwide.
Assure compliance of regulatory requirements for new commercial initiatives.
Build the regulatory strategy across Elevar’s product portfolio.
Provide strategic vision, expertise and leadership in the development of products and regulatory approvals in the US, UK, Europe and worldwide.
Think strategically about the development pipeline for Elevar and assess which products are most likely to move through the regulatory process efficiently.
Manage meetings with global regulatory authorities including meeting requests and preparation of briefing packages.
Build and manage relationships with global regulatory agencies (e.g., FDA, EMA, etc.) and standards groups.
Represent Elevar before global regulatory authorities.
Develop realistic, but tight, timelines and coordinate the activities of all departments towards achieving high-quality (defined as first time acceptance) and on-time submissions.
Manage changes in product labeling.
Manage the provision of regulatory information to both internal and external customers through commercial communication.
3. Candidate Requirements
20+ years’ progressive related experience in drug development with at least 15 years in regulatory affairs.
Regulatory Affairs Professional Society (RAPS) certification preferred.
Graduate degree in a relevant life science is preferred, but a bachelor’s degree is acceptable with additional experience.
Prior experience as a senior leader (Director or above) of regulatory affairs for a biopharmaceutical company is required.
Established relationships with regulatory agencies are desirable.
Excellent knowledge of the USA/EU regulatory pharmaceutical framework. Proven experience of achieving regulatory approvals in the USA and EU.
A commercial focus in the application of regulatory requirements.
Outstanding communication skills, both verbal and written, and the ability to interface effectively across key functional areas including: Clinical, CMC, Quality, Commercial and Legal.
Strong conceptual, analytical and problem-solving abilities.
A ‘hands-on’ individual who enjoys challenge, is capable and dedicated to getting the job done.
Have a strong results orientation, positive ‘can do’ attitude, and a sense of urgency to get things done.
Excellent time management and organizational skills demonstrated ability to manage and prioritize multiple teams, multiple projects and meet deadlines.
Proven experience in leading change management initiatives through periods of rapid expansion.
Superior communications skills including written, verbal, and presentation skills
Operate with the utmost ethics and discretion, earning trust with peers, C-suite, and entire staff.
An inspirational leader with dedication towards team and people development.
Naturally collaborative, with proven integrity and professional agility.
Ability to interface with cross-functional teams and achieve goals.