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Company

Summit Therapeutics, Inc. · 12 hours ago

Senior Director, Regulatory Affairs – Global Regulatory Leader

United States

Full-time

Remote

Senior Level, Lead/Staff, Director/Executive

$255K/yr - $275K/yr

10+ years exp

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BiotechnologyHealth Care

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Responsibilities

Leads preparation of US, EU, Canadian and Japanese regulatory product strategies for assigned products. Ensures compliance with global regulatory requirements.

Manages compounds through all phases of development, throughout the life cycle of the product

Continually expands TA knowledge, and ensures strategic messaging and content of global regulatory dossiers

Advises management of the effect of current or proposed laws, regulations, guidelines, and standards, etc.

Key internal leader and driver of regulatory policy and strategy for assigned products

Leads regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products

May lead the Labeling Regulatory Team

Proactively anticipates and mitigates regulatory risks

Demonstrates excellent understanding of drug development and leadership behaviors consistent with level

Develops and implements acceleration strategies

Manages projects and necessary documentation of regulatory strategies

Accountable for ensuring that corporate goals are met

Acts independently under direction of Head of RA

Based on experience and scientific strengths, expands TA knowledge of TA; provides coaching and mentoring for other regulatory members

Will have direct reports and contributes to the performance management for other RA team members

May influences the development of regulations and guidance

Advises internal personnel on regulatory strategies

Designs and Implements policies and procedures for regulatory record keeping and procedures, ensures direct reports follow requirements

Proactively informs of issues, risks and mitigations

Provides informed regulatory opinion based on experience and expertise

Makes decisions regarding regulatory work processes or operational plans and schedules in order to achieve the program objectives established

May advances the organization's goals by participating and taking leadership roles in professional associations, industry, and trade groups as appropriate

Follows budget allocations

All other duties as assigned

Qualification

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Regulatory AffairsDrug DevelopmentGlobal Regulatory StrategiesProject ManagementRegulatory ComplianceCross-Functional CollaborationComputer SkillsPharmacyBiologyChemistryPharmacology

Required

Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject

10+ years' experience in pharmaceutical regulatory activities, with experience as lead regulatory product strategist in two or more major regions in addition to the US, such as EU, Japan, or China

Requires drug development experience in US & EU

Minimum of 5+ 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

Communicate effectively and articulate complex ideas in an easily understandable way

Prioritize conflicting demands

Ability to successfully work in a fast-paced, demanding and collaborative environment

Travel up to approximately 5%

Preferred

Masters or Doctorate preferred

Benefits

Bonus

Stock

Benefits

Other applicable variable compensation

Company

Summit Therapeutics, Inc.

Summit Mission Statement: To build a viable, long-lasting health care organization that assumes full responsibility for designing, developing, trial execution and enrollment, regulatory submission and approval, as well as successful commercialization of patient, physician, caregiver, and societal-friendly medicinal therapy intended to: improve quality of life, increase potential duration of life, and resolve serious medical healthcare needs.

Founded in 2003

Abingdon, Oxfordshire, GBR

51-200 employees

https://www.summittxinc.com

H1B Sponsorship

Summit Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2023 (1)