Client has a program for a subcutaneous formulation of a combo product. They are ending Phase II and will need someone to lead and drive the closeout in order to enter into Phase III by end of the year. Candidate will need to be able to lead meetings, have experience with clinical trial applications, as well as combination products. There are 10 countries ex US that are involved with this program, so international experience is a must. They will not be in an authoritative role, but will be the Sr. Directors right hand person. Personality is huge, must be personable and able to adapt easily to the group
The Director of Regulatory Affairs is responsible for leading both the strategic and operational aspects of
Regulatory Affairs objectives for products marketed in the U.S., E.U., and rest-of-the-world (ROW) as well as development stage products. This position is also responsible for coordinating all aspects of regulatory
submissions for assigned projects, providing guidance on post-approval changes, developing regulatory strategy, and representing the function on cross-functional teams.
Provides regulatory leadership to cross-functional teams, ensuring cross-functional perspective/expertise is incorporated in regulatory plans prior to decisions being made.
Assists in the formulation of regulatory strategies to optimize regulatory timings, competitive positioning and opportunities.
Manages Health Authority liaisons responsible for regulatory strategy, tactics and direction to product development in preparation of submission documents, responses to queries by regulatory agencies.
Directs the team in developing, implementing and delivering a regulatory strategy for highly complex products which balance time, cost, quality and risk which meets the needs of Horizon. Drives
regulatory aspects of marketed product life cycle management including critical issue management and major line extensions.
Manages the preparation and timely submission of regulatory documents.
Presents regulatory strategies to internal governance bodies. Influences internal and external customers as necessary to ensure successful strategy implementation.
Provides interpretative analyses of complex regulatory guidance documents, regulations, or directives that impact the company’s products and operations.
Ensures quality and compliance of regulatory activities by adhering to established corporate and functional processes, guidelines and SOP’s.
Cultivates relationships with key colleagues in other parts of the organization
Bachelor’s degree in Life Sciences, Chemistry or Biology. Advanced degree a plus.
15 years previous biotechnology and/or pharmaceutical drug development experience.
12 years regulatory affairs experience preferably involving direct contact with regulatory agencies; full knowledge of FDA, EU & ICH regulations and guidelines, and the ability to provide interpretations of the information to others.
Solid understanding of dossier requirements New Drug Application/Biologics Licensing Application
(NDA/BLA), Marketing Authorization Application (MAA) and Clinical Trial Authorization (IND, IMPD,
CTA) and ability to strategically interpret and respond to requests from regulatory agencies.
Ability to work with high level contacts and exposure to sensitive information necessitating considerable use of tact, diplomacy, discretion, and judgment.
Preferred knowledge and experience with the regulatory process for approval of both biologics and combination products
Demonstrated ability to work and draft documents in a fast-paced environment
Flexible with respect to prioritization of daily tasks and projects according to internal and external influences
Strong organizational skills and attention to detail
Excellent written and verbal communication skills
Leadership capabilities working across varied cultures, expertise, and backgrounds.
Remote: Dir Regulatory Affairs-International (232462)