Senior Director, Regulatory Strategy - Alpha-1 Antitrypsin Deficiency
Company: Vertex Pharmaceuticals
Location: Boston
Posted on: June 25, 2022
Job Description:
Job DescriptionGeneral Summary:The Senior Director, Regulatory
Strategy, is a regulatory leader with expert technical and tactical
experience in regulatory strategy for the assigned global or
regional position and will be responsible for overseeing the
development and implementation of advanced global regulatory
strategies for development programs (1) in emerging disease areas,
(2) for additional development of registered Vertex medicines,
and/or (3) for the support of Vertex marketed products. This
incumbent will play a major role in shaping cohesive regulatory
strategy across the assigned programs and ensuring effective
integration of broad regulatory ideas/tactics supporting franchise
strategy. This roles responsibilities may be global, regional or
local depending on the position and assigned region. This role will
understand and translate regulatory, scientific, operational and
business knowledge into effective implementation plans and
strategy.Key Duties and Responsibilities:
- Leads the development of regulatory strategy for multiple
and/or complex projects in development (from first-in-human to post
marketing application stage) outlined in Global Regulatory Strategy
Documents including for regulatory submission documents and Health
Authority communications
- Represents GRA on core development teams, project teams, and
collaborate with regional leaders and teams to ensure unified
regulatory input into clinical programs and commercial
strategy
- Addresses complex issues, providing advanced regulatory
solutions and guidance to cross-functional teams and align
communication to and from cross-functional teams and GRA
leadership. Counsels and advises senior management on status of
global Regulatory Affairs strategies and tactics, procedures and
practices
- Leads the development and management of project plans and
timelines and assigns and manages resources effectively to ensure
all projects are appropriately prioritized and key goals are met on
time
- Works to influence regulatory environment through active
participation in conferences and industry/agency regulatory
meeting, committees and trade associations. Remains up to date on
changing regulations, and regulatory policy and intelligence
including competitive issues that influence regulatory
strategy.
- Leads continuous improvement efforts on existing department
processes and strategies, providing recommendations in area of
expertise
- Leads GRA functional team(s) including participating in the
skill development, coaching, and performance feedback for members
of the GRA functional teams
- As a people manager within the organization, may have financial
accountabilities and human resource responsibilities for assigned
staff.Knowledge and Skills:
- A business-minded leader, capable of strategic thinking and
proposing innovative solutions to regulatory problems
- Demonstrates excellent communication skills with ability to
impact and influence the decisions of a team, communicates with all
levels within the company and act as liaison / representative both
internally and externally and communicates effectively in verbal
presentations and in writing regulatory strategy plans and
submission documents
- Able to provide regulatory leadership on a cross-functional
team and work effectively in a matrix environment
- Demonstrated technical expertise in regulatory affairs science
including advanced knowledge of regulatory frameworks and external
environments. Expert knowledge of global/regional/local regulatory
legislation, laws, procedure and guidance for pharmaceutical
development of medicines for human use, with demonstrated knowledge
of the research and development, preclinical and clinical
requirements related to drug development, registration, and
maintenance of human pharmaceuticals
- Advanced proficiency in analyzing and interpreting data,
protocols, safety reporting, labeling and other activities related
to the phases of drug development for assigned products.
- Demonstrated expertise in creating and assessing proposals to
regulatory authorities on regulatory paths and clinical plans, and
in leading productive health authority interactions, including well
organized preparation of cross functional teams.
- Demonstrated expertise in analyzing the adequacy of proposed
regulatory pathways and strategies and guiding development teams
with recommendations for changes/refinements based on ongoing
regulatory outcomes throughout development.
- Ability to articulate the organization's strategic vision and
core values, and successfully contribute to improving the quality
of internal regulatory policies, programs and initiatives.
- A strong leader who demonstrates sensitivity and understanding
of cultural considerations, embraces diversity, and continuously
develops staff by providing feedback, coaching, guidance and
mentoring.Education and Experience:
- Bachelor's degree in Biology, Chemistry, or other related
discipline
- Typically requires 12 years of relevant pharmaceutical or
biotech industry experience within regulatory affairs and 5 years
of supervisory/management experience, or the equivalent combination
of education and experienceWe're enabling flexibility and choice
between individuals and their managers to maintain our strong
culture of collaboration and ensure a daily vibrancy within our
sites globally. In this Hybrid- or On-Site-Eligible role, you can
choose to work:1. Hybrid and work remotely up to two days per week
on regularly scheduled days; or select2. On-Site work 5 days per
week with ad hoc flexibility.#LI-EE1 #LI-HybridCompany
InformationVertex is a global biotechnology company that invests in
scientific innovation.Vertex is committed to equal employment
opportunity and non-discrimination for all employees and qualified
applicants without regard to a person's race, color, sex, gender
identity or expression, age, religion, national origin, ancestry,
ethnicity, disability, veteran status, genetic information, sexual
orientation, marital status, or any characteristic protected under
applicable law. Vertex is an E-Verify Employer in the United
States. Vertex will make reasonable accommodations for qualified
individuals with known disabilities, in accordance with applicable
law.Please note that Vertex requires COVID-19 vaccination for all
employees working in the U.S. as a condition of employment at
Vertex, subject to medical, religious or other accommodations or
exemptions required by law. We believe this requirement is vital to
keeping everyone at Vertex and in our communities safe. This
requirement applies to both existing and new employees who may at
any time work on-site at a Vertex facility or visit another
location on behalf of Vertex (e.g., conferences, customer visits,
etc.), including all remote employees. Any applicant requiring an
accommodation in connection with the hiring process and/or to
perform the essential functions of the position for which the
applicant has applied should make a request to the recruiter or
hiring manager, or contact Talent Acquisition at
ApplicationAssistance@vrtx.com.
Keywords: Vertex Pharmaceuticals, Boston , Senior Director, Regulatory Strategy - Alpha-1 Antitrypsin Deficiency, Executive , Boston, Massachusetts
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