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Head of Regulatory Affairs

MAJOR RESPONSIBILITIES

• Provides regulatory leadership to cross-functional product teams and Regulatory department.
• Leads the organization in developing, implementing and delivering regulatory strategies for complex products which balances time, cost, quality and risk and which meets the needs of patients, prescribers, payers, regulators and Business for an optimal label to commercialize products.
• Assures business objectives are understood and taken into account during regulatory strategy development.
• Strategizes, plans and executes complex submissions to health authorities.
• Represents Progenics as lead interface with health authorities (e.g., FDA). Establishes effective working relationships with health authorities and directs health authority interactions with teams.
• Establishes and maintains effective working relationships with development and business teams. Ensures cross-functional perspectives/expertise is incorporated into regulatory plans prior to decisions being made.
• Manages decision-making and conflict resolution surrounding regulatory issues within the organization. Ensure appropriate escalation of issues when necessary.
• Drives regulatory aspects of marketed product life cycle management including critical issue management.
• Develops regulatory risk management and contingency plans. Communicates plans to management as appropriate.
• Analyzes regulatory environment for impact on project/plans and communicates the impact appropriately.
• Acts as a change agent and role model by modeling best practices.
• Ensures quality and compliance of regulatory activities by adhering to established corporate and functional processes, guidelines, and SOPs.

 

CORE COMPETENCIES

• Leadership – Drives teams toward meeting regulatory objectives. Takes responsibility to resolve issues objectively. Manages regulatory resources. Empowers individuals to get their job done as experts on the team. Represents Progenics to key decision makers in Health Authorities.
• Influence Management – demonstrates capability to obtain win-win situations in a matrix management organization through influence management skills, persuasion and networking.
• Strategic Thinking/Business focus – demonstrates ability to assess priorities and set strategies to align with/meet business needs. Demonstrates ability to analyze data and regulatory environment and apply this to development of sound global regulatory strategies for complex projects.
• Interpersonal Skills/Communication -Expresses complex ideas clearly/succinctly both in writing and verbally. Builds trust and respect with peers and team members. Fosters good interpersonal relationships. Skilled at conflict resolution/negotiation. Fosters open communication. Listens and facilitates discussions. Represents regulatory views and decisions to the team/organization.
• Teamwork – Builds trust and respect. Seeks opportunities to increase morale/motivate team. Encourages change, innovation and accountability within the team and function.
• Job Knowledge – possesses expert knowledge of regulatory. Possesses appropriate scientific and drug development knowledge and experience.

 

QUALIFICATIONS

• Education: Ph.D. in Life Sciences
• Experience: Candidates should have a minimum of 10-15 years of experience in pharmaceutical drug development as a regulatory lead.
• Demonstrated expertise in leading global strategic regulatory development of products from entry into man through life cycle management across therapeutic areas/product classes.
• Demonstrated expertise in leading/delivering original IND/NDA/510K filings and management of filing review process across therapeutic areas/product classes.
• Demonstrated command of core competencies listed above.

 

TECHNICAL SKILLS

• Proven track record of successfully bringing new products to the clinic through approval and commercialization
• Thorough understanding of drug development process and FDA regulations is required
• Experience in late stage development programs, radiopharmaceuticals, post-approval and commercial experience is required
• Experience or familiarity with radiopharmaceuticals products and/or breakthrough designation is highly desirable
• Experience or familiarity with medical devices (e.g. 510k) is also desirable
• Familiarity with senior personnel in the FDA drug divisions a plus
• Strong problem solving, negotiation, and multi-functional team leadership skills
• Ability to build cross-functional relationships across the company including Development and Legal & Compliance
• Excellent oral and written communication skills

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