Hemab seeks a Director, Regulatory Affairs who will be responsible for developing and executing innovative global regulatory strategies for the global development of candidates for the treatment of rare, hematological disorders. This position will define, develop, and lead execution of strategies to maximize global regulatory success and achieve program objectives for complex development projects in the rare disease space. The Director Regulatory Affairs will be response for keeping abreast of new developments in regulatory science and maintaining oversight on the evolving regulatory landscape and advancing innovations. In addition, the Director Regulatory affairs must understand and interpret scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy.

This role is expected to be a leader, contributing to cross-functional initiatives and influencing the field, as applicable. You may represent Hemab in industry/regulatory forums to lead regulatory innovation. This role is ideally suited to a candidate who is self-motivated and excited by an opportunity to rise to frequent and diverse challenges.

Duties/Responsibilities

Will be responsible for complex and potentially multiple projects within the Rare Disease space. Responsible for development of regulatory strategies related to development and licensure of biologic development products. Represents Regulatory Affairs at project team meetings.
Collaborate across technical functions to create innovative regulatory strategies for projects and pragmatic solutions to deliver on the proposed strategy with the project teams.
Effectively communicates through presentations and written communications regulatory strategies and project developments to project teams, colleagues, line management, and key stakeholders for alignment and to ensure awareness of issues that may impact regulatory success. Communications demonstrate sound judgement and are provided in a professional and timely manner.
Responsible for proactively anticipating regulatory risks and for developing mitigation strategies in alignment with team and management; understands relative strengths, weakness, and probabilities of technical success for the mitigation strategies proposed.
The Director will be accountable for all Regulatory Agency submissions and approvals of project(s) of responsibility, overseeing outsourced vendors and/or Hemab internal team members.
Direct point of contact with health authorities, leads and manages Regulatory Agency meetings, in cooperation with outsourced vendors.
Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
Participates in or leads departmental and cross-functional taskforces and initiatives.
Partner with global market access colleagues to lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable.
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.

Who You Are

You are a strategic thinker who also thrives on execution -someone who can shape the regulatory storyline while still being willing to dive into the details an author high-quality content yourself.
You bring expertise in global CMC regulatory requirements and approach challenges with confidence, clarity, and a solutions-oriented mindset. You are a try partner to the Copenhagen-based team, working hands-on in the day-to-day execution, supporting cross-functional colleagues, and ensuring momentum across programs

Qualifications & Experience

Bachelor’s degree in a scientific subject area coupled with sufficient industry experience. Advanced degrees (e.g. MSc, PhD, PharmD, MD) preferred.
8+ years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or a combination of 5+ years regulatory and/or related experience. Experience in rare diseases, especially rare hematological disorders, preferred.

Skills & Abilities

Understands and works effectively with team members and consultants to develop the regulatory framework for the clinical development of small molecules and biologic products leading to global marketing authorizations.
Ability to advise on applicable regulations and guidance documents, including providing interpretation of these governing documents by regulators as experience is gained in practice.
Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy.
Keeps abreast of new developments and therapeutic innovations, including regulatory requirements related to gene therapy and associated science.
Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity, and adaptability.
Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
Demonstrated ability to work well within global teams and success leading cross-functional regulatory work products.

Physical Demands

Ability to remain seated for long periods of time while working on computer or referring to documents.
Must have manual dexterity to operate computer keyboard and standard office equipment.
Positions: Standing, walking, sitting, stooping.
Travel may be required (up to 10% of the time).