VP Regulatory & Clinical Affairs
YOU CAN CREATE THE VISION!
At Tribeca Companies, you can get in on the ground floor as we build a world-class life sciences business.
We are seeking a Vice President, Regulatory & Clinical Affairs to assist our growing team of business and medical professionals In this role, you will lead our regulatory and clinical strategy for our portfolio companies and products. The Vice President advises the Company’s business units to ensure their compliance with regulatory/clinical requirements and oversees all regulatory/clinical submissions and their alignment with commercial initiatives. The Vice President develops and directs a strong regulatory and clinical strategy that supports growth opportunities in the commercial businesses.
- Leads and builds our Regulatory & Clinical Affairs organization.
- Provides training and interpretation of FDA and other regulatory issues for all products in both clinical development and available commercially.
- Oversees the Company’s compliance with regulatory agencies and all applicable standards worldwide.
- Assures compliance of regulatory and clinical requirements for new clinical and commercial initiatives.
- Builds the regulatory and clinical strategy across the Company’s product portfolio.
- Works with IRBs to ensure timely clinical approvals for any ongoing and upcoming clinical studies.
- Coordinates/facilitates all clinical trials.
- Provides strategic vision, expertise, and leadership in the development of products and regulatory approvals in the US and OUS.
- Thinks strategically about the development pipeline for the Company and assesses which products are most likely to move through the regulatory process efficiently.
- Manages meetings with regulatory authorities, including meeting requests and preparation of briefing packages.
- Builds and manages relationships with global regulatory agencies and standards groups.
- Represents the Company before global regulatory authorities.
- Develops realistic, but tight, timelines and coordinates the activities of all departments towards achieving high-quality (defined as first-time acceptance) and on-time submissions.
- Manages changes in product labeling.
- Manages the provision of regulatory information to both internal and external customers through commercial communication.
Key Skills & Experience
- 10-15+ years of progressive-related experience in regulatory and clinical affairs.
- Regulatory Affairs Professional Society (RAPS) certification preferred.
- A graduate degree in 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 & clinical affairs for a lifesciences company is required.
- Established relationships with regulatory agencies are desirable.
- Excellent knowledge of the USA FDA/EU regulatory framework. Proven experience of achieving regulatory approvals (especially 510ks and de novos) 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.
- Strong conceptual, analytical, and problem-solving abilities.
- Excellent time management and organizational skills demonstrated the 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 written, verbal, and presentation skills.
More About Tribeca Companies
Who We Are
Tribeca Companies is a global investment firm specializing in equity and real assets investing. We focus on high-impact ventures in early and expansion-stage companies with robust track records and potential for growth. Our past and present portfolio includes more than 300 investments totaling over $3 billion in transaction value. We are a transactional powerhouse that combines an extensive network of relationships with deep-sector expertise, seasoned operational and deal sophistication. We identify uncommon opportunities, amplify achievement, and facilitate positive social outcomes.
What We Do
PRIVATE EQUITY: TECHNOLOGY & BIOSCIENCE
We are a health-solutions investment firm focused on high-impact bioscience and technology concerns. We provide capital and end-to-end operational administration and management. In this way, we amplify business growth, financial success, and we position our portfolio companies to become catalysts for positive social change.
For more information or to apply, contact us at firstname.lastname@example.org.
Job posted: 2021-04-10