Highly focused and successful specialty-driven biotech/pharma company that recognizes and promotes an entrepreneurial spirit in our employees, and are building a strong legacy of helping patients with difficult-to-treat diseases across specific therapeutic diseases areas. Company commitment to deliver effective therapeutic solutions through highly differentiated medicines and treatments for patients with unmet needs.
The ideal selected candidate leads both the strategic and operational aspects of Regulatory Affairs objectives for products, life cycle management initiatives and acquisitions including FDA regulatory strategy, regulatory submissions, and interaction with regulatory authorities. This role is also responsible for managing existing INDs and initiating INDs for pipeline products, subsequent FDA filings, as well as clinical trial applications and all other documentation to be compliant with all regulatory requirements.
- Provides regulatory leadership to cross-functional teams through strong collaboration, ensuring perspective/expertise is incorporated in regulatory plans prior to decisions being made to secure FDA approval of new drugs and new indications for existing drugs.
- Directs team development, implementation and delivering a regulatory strategy for highly complex products which optimize the balance of time, cost, quality and risk to meet the needs of the organization.
- Drives regulatory aspects of marketed product life cycle management including critical issue management and major line extensions.
- Presents regulatory strategies to internal governance bodies. Influences internal and external customers as necessary to ensure successful strategy implementation and in support of business marketing goals.
Operations, Quality, Compliance:
- Responsible for generating and implementing operational regulatory practices to support document creation and submission across the company’s development and commercial product portfolio.
- Leads interactions with project team members, consultants, contractors and regulatory authorities to ensure regulatory paths are clearly defined and milestones are met leading to successful filings and approvals.
- Accountable for the timely development and submission of regulatory documents (e.g., pre-IND and end-of-phase briefing books, INDs, NDA/BLAs, CTAs, MAAs, responses to regulatory queries, IND safety reports, etc.).
- Ensures quality and compliance of regulatory activities by adhering to established corporate and functional processes, guidelines and SOPs. Creates and implements new SOPs as necessary to maintain regulatory compliance with new drug regulations.
- Provides interpretative analyses of complex regulatory guidance documents, regulations, or directives that impact the company’s products and operations and leads the response respectively.
- Seeks innovative and creative operational solutions that comply with regulations and are sound from business and scientific perspectives.
- Responsible for overall assessment of scientific data for registration purposes against regulatory requirements.
- Provides contingencies and alternate approaches to Senior Management and/or partners to resolve any development program challenges.
- Responsible for management of Regulatory Affairs budget.
Communications and Leadership:
- Leads communications ensuring internal awareness and understanding of regulatory legislation.
- Monitors and communicates development of new guidelines and procedures to assess the impact and ensure compliance for product development programs.
- Leads response on behalf of company to proposed FDA regulatory policies and guidelines.
- Actively manages all liaisons with regulatory authorities as needed for all aspects pertaining to drug development and approval.
- Provides strong leadership, training, development and ensures fit for purpose organizational design to the Regulatory team; enhancing and promoting staff growth and development.
- Perform other duties as assigned.
- Supervisory experience leading teams with responsibility for performance management and reward planning
- 12 – 15+ years R&D, medical or scientific experience within the pharmaceutical and/or biotech industry
- Advanced degree (e.g. PhD, PharmD, MD) in a relevant scientific discipline
- Experience working with FDA at the policy level (e.g. influencing direction of regulatory guidance) and ability to lead FDA strategy
- Due diligence/M&A experience
- Track record of successfully setting regulatory strategy, product registrations, and regulatory filings (e.g. IND, NDA and other similar regulatory filings) with FDA
- US regulatory experience
- Demonstrated leadership and motivation of staff to successfully execute regulatory strategies.
- Ability to resourcefully direct the development of creative solutions to unusually complicated regulatory and systems challenges
- Demonstrated ability to influence management, at all levels to support regulatory strategic and operational department needs.
- Highly proficient in communicating and presenting strategic and tactical issues to all levels, including top management and regulatory agencies
- Previous experience leading teams with responsibility for performance management and reward planning
up to $275K+ plus 30%-40% Annual Bonus + Stock options
Chicago or New Jersey/PA/NY Area
No, not at this time.
VT - 3212