Vice President, Regulatory Affairs

Job Summary:

The Vice President, Regulatory Affairs is responsible for global regulatory affairs for all drug development programs.  This individual contributes to the registration of truly innovative biopharmaceutical drugs at a company committed to making a difference in the lives of patients.  Provides leadership, develops strategies, and gives operational direction to all regulatory projects with the intent to gain global marketing approval.  This is a hands-on position.

Job Duties:

• Develops the global regulatory strategy for individual programs including preparing the programs for successful registration in major global markets
• Defines country-specific regulatory strategies for all programs, assessing optimal route to approval, leading communication and negotiation with global regulatory agencies, and leading the company’s effort in definitive submissions 
• Provides strategic regulatory leadership for all clinical development projects, including but not limited to, overall global regulatory strategy, regulatory requirements for registration in domestic and international markets, and regulatory risk assessments and mitigation for all Company  programs
• Leads communications with regulatory agencies. Prepares briefing and regulatory documents for regulatory agencies, such as Dossiers, NDAs, INDs, and Annual reports.  Responds to regulatory agencies with intelligence and diplomacy
• Ensures that all nonclinical and clinical programs such as pharmacology, toxicology, and clinical trials are appropriately informed and structured to meet US, European, and other regulatory requirements
• Ensures that all the manufacturing and quality programs relevant to the chemistry, manufacturing and controls of pharmaceutical products, such as process and manufacturing development, validation plans, production, release, and labeling, are appropriately structured to meet US, European, and other regulatory requirements
• Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through  sharing of knowledge, expertise, and relevant information
• Provides guidance and information to the Senior Management Team on emerging trends, regulations, and health authority guidelines to ensure use of the desired regulatory strategies

• Provides counsel, training and interpretation of FDA and other regulatory requirements to all Development staff members and where appropriate to other teams and individuals.  Cultivates an atmosphere of transparency and problem-solving that encourages requests for advice and input by company staff
• Interprets and communicates regulatory expectations to internal and external stakeholders (including partners, CROs, CMOs, consultants, and contractors) in order to execute program objectives in compliance with applicable regulations
• Develops and maintains strong relationships with key stakeholders and  regulatory officials
• Works with internal staff and outside consultants to achieve regulatory objectives

• Complies with all applicable policies regarding health, safety and environmental policies

Job Requirements: 

• PhD in a scientific area and at least fifteen (15) years of experience with progressive responsibilities in regulatory affairs within the biopharmaceutical industry, or equivalent. Must have at least ten (10) years of experience in a management role developing a high performing regulatory team
• Experience with regulatory aspects of oncology or rare disease products
• Ability to apply knowledge of FDA , EMA, and ICH guidelines both strategically and operationally
• Experience leading regulatory aspects of late stage drug development through market launch
• Demonstrated experience and expertise in preparing complex regulatory documents including INDs, milestone briefing packages (EOP2, EOP3, pre-NDA, Scientific Advice), NDAs,  and other major regulatory submissions
• Must have extensive knowledge of the regulations, regulatory process and requirements in all major global markets
• Ability to influence direction of complex regulatory issues; solicits information, listens well, persuades others to make important decisions and shape outcomes
• Demonstrated grace under pressure
• Proven leader with a strong results orientation, positive “hands on” attitude and a sense of urgency to get things done
• Strong written and oral communication skills
• Ability to travel up to 20% [domestic and international]