drjobs Senior DirectorExecutive Director Regulatory Affairs Strategy

Senior DirectorExecutive Director Regulatory Affairs Strategy

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1 Vacancy
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Job Location drjobs

San Diego, CA - USA

Monthly Salary drjobs

$ 260000 - 310000

Vacancy

1 Vacancy

Job Description

Ventyx is a clinicalstage biopharmaceutical company focused on developing innovative oral medicines for patients living with autoimmune and inflammatory disorders. We believe our ability to efficiently discover and develop differentiated drug candidates will allow us to address important unmet medical needs with novel oral therapies that can shift inflammation and immunology markets from injectable to oral . Our current pipeline includes internally discovered clinical programs targeting NLRP3 S1P1R and TYK2 positioning us to become a leader in the development of oral immunology therapies for peripheral and neuroinflammatory diseases.


The Opportunity: Senior Director/Executive Director Regulatory Affairs Strategy:

The Senior Director / Executive Director Regulatory Affairs will provide leadership in building a high performing global regulatory function for Ventyx Biosciences Inc. This position reports to the SVP of Regulatory Affairs.


What You Will Contribute:

  • Provides breadth and depth of regulatory expertise and leadership to crossfunctional product development teams.
  • Participates as a standing member in various teams dependent upon assigned projects and the associated programs coordinates crossfunctional contributions.
  • Responsible to ensure all RA deliverables associated with each project or other assignment are completed within defined timelines and meet relevant regulatory and company guidelines.
  • Oversees coordinates and delivers regulatory submissions and other relevant regulatory documentation.
  • Serves as the primary RA representative on one or more global studies.
  • Analyzes data the regulatory environment and business objectives to drive alignment on priorities.
  • Directs trains and guides internal teams on interactions with regulatory authorities.
  • Develops and drives regulatory risk management and contingency plans. Communicates plans to management as appropriate.
  • Provide strategic direction on current pharmaceutical regulations guidelines and practices and therapeutic area knowledge and ensures consistent best practice across all activities.
  • Additional duties assigned as needed.

What We Seek:

  • 14 years of years relevant experience in regulatory affairs or related functions in drug development
  • BS/BA degree in life sciences discipline or highly related field required advanced degree preferred
  • Broad understanding of international regulations processes and issues in drug development
  • Experience as a regulatory contributor for IND/CTA NDA/MAA filings
  • Confident and competent when interacting with varying levels of internal/external management raises issues or challenges in a productive and mature manner building strong positive relationships
  • Strong negotiation skills: can effectively drive discussions and decisions toward desired endresults
  • Strong writing skills with extremely high attention to detail
  • Excellent project management skills: can prioritize multiple tasks and goals to ensure the timely ontarget accomplishment
  • Strong interpersonal verbal communication and influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders both internally and externally
  • Proven track record of effective decisionmaking: makes good business decisions and exercises sound judgment. Consistently and effectively balances decisions with imperatives for ethics and efficacy
  • Broad and current knowledge of ICH GCP IRB/IEC and local regulatory authority drug research & development regulations
  • Motivated to work in a fastpaced high accountability environment
  • Demonstrated agility to learn and prioritize multiple responsibilities independently remove barriers and drive projects to completion
  • Ability to strike a balance between independent work and team interaction be a team player in a crossfunctional team
  • Proficiency in Microsoft Office and other productivity tools with an aptitude to learn new software and systems

What We Provide to You:

  • The opportunity to make a difference in peoples lives impacted by autoimmune and inflammatory diseases.
  • Participate in a team of life science professionals who value science data high work ethic and a meritocracy; access to all levels of the organization to get work done with a sense of urgency.
  • Competitive compensation and a comprehensive benefit package including stock options.

The anticipated annual base salary range for this role is $260000 $310000. Final compensation depends on multiple factors including but not limited to relevant experience skillset depth and breadth of knowledge internal equity company needs and market factors. Ventyx is a rapidly growing biotech company that offers competitive wages and benefits package including medical dental vision LTD time off a retirement plan and other voluntary benefits for employees. Ventyx is an equal opportunity employer and strives to maintain a work environment in which all individuals are treated with respect and dignity. Qualified applicants will receive consideration for employment without regard to race age ethnicity or national origin color religion sex (including pregnancy childbirth breastfeeding or related medical conditions) gender identity sexual orientation disability or medical condition (including genetic information or characteristics or those of a family member) military service or veteran status or any other characteristic protected by local state or federal laws rules or regulations.


Notice to Recruiters and Agencies:

The Human Resources team manages the recruitment and employment process for Ventyx Biosciences. To protect the interest of all parties involved Ventyx Biosciences does not accept unsolicited referrals or resumes from any source other than directly from candidates. We will not consider unsolicited referrals and/or resumes from vendors including and without limitation search firms staffing or recruiting agencies or feebased referral services. The submission of referrals or resumes by anyone other than a candidate directly to Ventyx Biosciences employees is strictly prohibited. Unsolicited referrals and resumes sent to Ventyx are deemed gratuitous and do not obligate Ventyx to pay fees should we hire from those resumes. Recruiters are requested NOT to contact or present candidates directly to our hiring managers or employees. Please direct all inquiries to


Required Experience:

Exec

Employment Type

Full Time

Company Industry

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