Be an early applicantLess than 25 applicants

Company

Summit Therapeutics, Inc. · 4 hours ago

Vice President, Regulatory Affairs

United States

Full-time

Remote

Director/Executive

$300K/yr - $330K/yr

15+ years exp

Maximize your interview chances

BiotechnologyHealth Care

H1B Sponsor Likely

Insider Connection @Summit Therapeutics, Inc.

Discover valuable connections within the company who might provide insights and potential referrals.
Get 3x more responses when you reach out via email instead of LinkedIn.

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

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Regulatory AffairsOncologyDrug DevelopmentGlobal Regulatory StrategiesProject ManagementStakeholder EngagementDatabase Skills

Required

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%

Benefits

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

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)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2023 (1)