Senior Director, Regulatory Affairs - Global Regulatory Leader

Summit Therapeutics Plc•Menlo Park, CA

47d•$238,000 - $298,000•Onsite

About The Position

The Senior Director of Regulatory Affairs - Global Regulatory Leader, is responsible for developing and implementing global strategies to secure IND/CTA approvals for various studies as well as providing regulatory leadership for planning and execution of subsequent global marketing applications for product(s) in the oncology therapeutic area.

Requirements

Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or related subject; Masters or Doctorate preferred
Minimum of 12+ 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
Attention to detail, accuracy, and confidentiality
Clear and concise oral and written communication 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
Ability to successfully work in a fast-paced, demanding and collaborative environment
Travel up to approximately 5%

Responsibilities

Leads global regulatory strategies for assigned products/indications through all phases of development. May include doing so in context of development collaborations and/or partnerships.
Continually expands TA knowledge and ensures strategic messaging and content of global regulatory dossiers, to include development of tumor landscape assessment to inform evolving development strategy.
Advises management and cross-functional team members of the effect of current or proposed relevant laws, regulations, guidelines, and standards, etc.
Key internal leader and driver of regulatory policy and strategy for assigned products
Lead regulatory team in the preparation and maintenance of risk assessment and mitigation strategy development for assigned products
May lead the Labeling Regulatory Team for given product(s)/indication(s)
Proactively anticipates and mitigates regulatory risks
Demonstrates excellent understanding of drug development and leadership behaviors consistent with level
Develops and implements acceleration strategies as appropriate
Accountable for ensuring that corporate goals are met with respect to assigned projects
Acts independently under direction of Vice President of Regulatory Affairs
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
Makes decisions regarding regulatory work processes or operational plans and schedules in order to achieve the program objectives established
May advance 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