Position Responsibilities

Our Client is seeking a Director of Global Regulatory Affair, this position will be responsible for providing global strategic and operational excellence, leading innovative and ambitious development solutions, and partnering cross-functionally with a sense of urgency, resilience, and energy to meet the unmet medical needs of patients. The incumbent will be the primary point of contact with global regulatory health authorities and will partner with the Quality & Compliance team to ensure compliance and quality in all regulatory communications, submissions, and processes. The incumbent will work closely with higher management, in this highly visible role to build a team and culture that aligns with the values of the organization and focuses on bringing safe, effective, and innovative therapies to patients with unmet medical needs and drive success in executing corporate strategies and goals.

In addition, the incumbent will work closely with teams from Discovery, Clinical Development and Operations, Pharmacovigilance, Medical Affairs, and external consultants to advance the company’s portfolio. The Director of Global Regulatory Affairs will be a strategic, dynamic, highly collaborative and successful leader who brings global regulatory, drug development, orphan and rare diseases experiences and experience in both development and marketed products.

Essential Duties

• Develop and implement innovative and effective regulatory strategies that may include pursuance of accelerated pathways, Breakthrough designation, Fast Track designation, Priority Review, Orphan designation, and Priority Medicines Scheme (PRIME) designation, in support of bringing Company’s portfolio of compounds through development and to the market.
• Work in close collaboration with the Senior Management of Global Regulatory Affairs and Quality & Compliance, the Regulatory Affairs team members, and consultants/contractors to integrate and successfully implement all aspects of US and global regulatory strategies.
• Work collaboratively with cross functional team members and key internal stakeholders to prepare for regulatory submissions including coordination of meeting requests, writing and management of briefing documents, leadership at both rehearsal and meetings/TCs, and appropriate follow-up and integration of results into global strategy
• Serve as advisor on regulatory issues in support of portfolio and therapeutic areas; actively collaborate with management and cross functional colleagues within Company
• Provide expert regulatory affairs review, input, opportunity and risk assessment into confidential, strategic and often complex due diligence initiatives.
• Develop, write, and implement standard operating procedures and/or instructions as needed
• Provide input into FDA Guidance’s to regulatory policies

Organizational Relationships

Internal: Work with cross functional individuals and teams from Clinical Development, Operations, Pharmacovigilance, Commercial, Legal, Project Management, nonclinical, and Discovery

External: US FDA, EMA, and other global Regulatory Health Authorities; HTAs, and other third-party consultants, contractors, and organizations.

Education and Experience

Bachelor and master’s Degree in a scientific discipline required, Pharm.D., or Ph.D. preferred

3-5 Years as Director and 10-15 years of global regulatory affairs with proven experience in developing global strategy, operations, and management.

Experience providing strategic regulatory advice for the global development of products through all stages of development including pre-approval and marketed compounds.

Prior experience and a successful track record within the biotechnology and pharmaceutical industry in successful submission of INDs, CTAs, Meeting documents, and accelerated pathway designations.

Understanding and experience writing and implementing accelerated pathway designations for orphan drugs in the rare disease space.

Experience working in a fast-paced, matrixed environment

Technical / Functional Skills and Knowledge

Strong regulatory knowledge of global drug development, including clinical trial requirements, trial design and data analysis, manufacturing, and quality.  Strong knowledge of drug development and regulatory policy; excellent scientific and business judgment.

Ability to operationalize strategy and operate effectively within an entrepreneurial and science driven company environment.  Sound project, financial and operational management capabilities; ability to manage expectations, to stay on time and within budgets.  Ability to manage complex issues and coordinate multiple projects simultaneously

Ability to build team relationships and collaborate in a global team environment at all levels of the organization. Adept at change management. Strong interpersonal, communication and leadership skills.