Executive Director, Regulatory Affairs
The Executive Director Regulatory Affairs will report to the Vice President Regulatory Affairs and will manage the Regulatory Affairs Nonclinical and Clinical Strategy Group within the Regulatory Affairs function. This leadership position offers an exciting opportunity to contribute to the regulatory strategy for global expansion and life cycle management of Oxbryta and to influence the clinical development and registration strategy of small molecule and biologic pipeline products for the treatment of sickle cell disease. The position will be a HQ-based with flexibility regarding the number of days in the office/week. Essential Duties and
Responsibilities:
Lead and mentor Global Regulatory Leaders (GRLs) and their direct reports to ensure timely development and execution of innovative and robust global regulatory strategies and to guide the preparation of quality regulatory submissions to maximize regulatory success and minimize time to approval. Serve as an interim GRL when needed. Serve as regulatory subject matter expert and influential leader within the R&D organization to contribute to drug development at GBT. Effectively represent the Regulatory Affairs function in senior level interactions at internal governance committees and in meetings with health authorities and external partners. Ensure line management and key stakeholders are apprised of developments that may impact regulatory success. Anticipate risks and lead internal discussions to find innovative solutions for the identified risks, including assessment and communication of probabilities of technical and regulatory success. Provide regulatory strategy support for business development opportunities as needed. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and, when necessary, provide guidance to the GRLs and Regional Regulatory Leads to adapt the regulatory strategies and communicate the changes to management and key stakeholders. Lead/contribute to cross-functional initiatives. Develop best practices as needed. Qualifications and Expectations:
Advanced degree in a scientific subject area (e.g., MS, PhD, PharmD, and/or MD) with global regulatory experience preferred. BS/BA accepted. Fifteen years plus of biopharmaceutical experience with at least twelve years hands-on regulatory affairs experience and at least six years managing direct reports. Prior experience with rare disease drugs is a plus. Thorough understanding of relevant regulations and guidelines, including ICH, FDA, and EMA guidelines, for all stages of development of small molecule and biologic products. Experience in authoring, reviewing, and managing major regulatory submissions and responses to health authority questions. Demonstrated ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy. Proven ability to develop and manage Regulatory Affairs team(s) focused on accountability and meeting and exceeding expectations. Strong strategic thinking and analytical skills with ability to execute. Detail-oriented and results-driven with strong written, verbal communication, and presentation skills. Strong interpersonal and influencing skills; can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally. Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view. Fit with GBT culture:
Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE:
This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite at the Company's facilities. The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.
Salary Range:
$250K -- $500K+
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
Lead and mentor Global Regulatory Leaders (GRLs) and their direct reports to ensure timely development and execution of innovative and robust global regulatory strategies and to guide the preparation of quality regulatory submissions to maximize regulatory success and minimize time to approval. Serve as an interim GRL when needed. Serve as regulatory subject matter expert and influential leader within the R&D organization to contribute to drug development at GBT. Effectively represent the Regulatory Affairs function in senior level interactions at internal governance committees and in meetings with health authorities and external partners. Ensure line management and key stakeholders are apprised of developments that may impact regulatory success. Anticipate risks and lead internal discussions to find innovative solutions for the identified risks, including assessment and communication of probabilities of technical and regulatory success. Provide regulatory strategy support for business development opportunities as needed. Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and, when necessary, provide guidance to the GRLs and Regional Regulatory Leads to adapt the regulatory strategies and communicate the changes to management and key stakeholders. Lead/contribute to cross-functional initiatives. Develop best practices as needed. Qualifications and Expectations:
Advanced degree in a scientific subject area (e.g., MS, PhD, PharmD, and/or MD) with global regulatory experience preferred. BS/BA accepted. Fifteen years plus of biopharmaceutical experience with at least twelve years hands-on regulatory affairs experience and at least six years managing direct reports. Prior experience with rare disease drugs is a plus. Thorough understanding of relevant regulations and guidelines, including ICH, FDA, and EMA guidelines, for all stages of development of small molecule and biologic products. Experience in authoring, reviewing, and managing major regulatory submissions and responses to health authority questions. Demonstrated ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy. Proven ability to develop and manage Regulatory Affairs team(s) focused on accountability and meeting and exceeding expectations. Strong strategic thinking and analytical skills with ability to execute. Detail-oriented and results-driven with strong written, verbal communication, and presentation skills. Strong interpersonal and influencing skills; can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally. Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view. Fit with GBT culture:
Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Values-based leadership consistent with GBT's Core Values Excitement about the vision and mission of GBT Flexibility Integrity NOTE:
This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law. This position requires you to work onsite at the Company's facilities. The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law). Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.
Salary Range:
$250K -- $500K+
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
