Executive Director, Regulatory Affairs

Overview of Role:

The Vice President, Regulatory Affairs is responsible for developing and overseeing global strategies, RA operations, and global labeling to secure IND/CTA approvals for various studies as well as obtain and later maintain market approval for product(s) in oncology.

Role and Responsibilities:

• Oversees preparation of US, EU, Canadian, and Japanese regulatory product strategies for assigned products/indications and ensures compliance with global regulatory requirements
• Oversees management of compounds through all phases of development, throughout the life cycle of the product
• Continually expands TA knowledge and that of the regulatory affairs team
• Oversees strategic messaging and content of global regulatory dossiers
• Provides insights and informed regulatory opinion to C-suite on the effect of current or proposed laws, regulations, guidelines and standards, etc., and recommends adjustments to strategies and timelines
• Key internal leader and driver of regulatory policy and strategy for assigned product/indications
• Oversees regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products/indication; proactively anticipates, informs, and mitigates regulatory risks
• Oversees Labeling Regulatory staff / contractor(s)Demonstrates excellent understanding of drug development in oncology and leadership behaviors consistent with level
• Develops global acceleration strategies and ensure successful implementation
• Oversees all regulatory projects and necessary documentation of regulatory strategies and operational plans in order to achieve program objectives
• Accountable for ensuring that corporate and functional goals are met
• Acts independently under direction of Chief of RA/PV/QA
• Provides coaching, management, and mentoring for regulatory affairs team members
• Influences the development of regulations and guidance as applicable
• Advises internal personnel on regulatory strategies
• Oversees the designs and ensures successful and timely implementation of policies and procedures for regulatory record keeping and procedures; ensures direct reports follow requirements
• Develops and follows budget allocations
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• Doctorate or Master’s degree in life sciences (pharmacy, biology, chemistry, medicine pharmacology) or related field
• Minimum of 15 years' experience in pharmaceutical regulatory activities in oncology, with experience as lead regulatory product strategist in two or more major regions in addition to the US, such as EU, Japan, or China
• Drug development experience in US & EU required
• Minimum of 7 years of proven experience in a strategic leadership role with strong project management skills
• Experience working in a cross functional environment with multiple stakeholders and influencing cross-functional teams
• Experience interfacing with major government regulatory authorities
• Strong communication and proactive negotiation skills
• Experience developing and implementing successful global regulatory strategies
• Strong computer and database skills
• Attention to detail, accuracy and confidentiality
• Clear and concise oral and written communication skills
• Excellent organizational skills
• Critical thinking, problem solving, ability to work independently.
• Must be able to effectively multi-task and manage time-sensitive and highly confidential documents
• Ability to communicate effectively and articulate complex ideas in an easily understandable way
• Ability to prioritize conflicting demands
• Ability to work in a fast-paced, demanding and collaborative environment
• Travel up to 15%

The pay range for this role is $300,000 - $330,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. The successful candidate will also be eligible for health benefits, 401(k) with 6% employer match from day one, ESPP with up to a 15% discount up to the federal limit, flexible spending account among other benefits compensation.

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