Director, Regulatory Affairs - REMOTE

Proclinical is seeking a remote Director, Regulatory Affairs for a cutting-edge biotechnology company.

As the Director, Regulatory Affairs, you will be responsible for developing and executing innovative global regulatory strategies.

Must be eligible to work in the US.

Job 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 Sr Director/Director will be accountable for all Regulatory Agency submissions and approvals of project(s) of responsibility, overseeing outsourced vendors and/or 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 with influence 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.

Skills and Requirements:

• Bachelors degree in a scientific subject area coupled with sufficient industry experience. Advanced degree (e.g. MSc, PhD, PharmD, MD) preferred.
• [Sr Director] 12+ years of pharmaceutical industry experience inclusive of 10 years of regulatory experience or a combination of 8+ years of regulatory and related experience.
• [Director] 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.
• 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.

If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at +(1) 646-367-2908 or n.walker@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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