Associate Director, Regulatory Affairs (Remote Position)
The Associate Director of Regulatory Affairs will report to the Director, Regulatory Affairs and will provide leadership on global clinical regulatory activities for Global Blood Therapeutics, Inc. (GBT) compounds for the treatment of sickle cell disease (SCD). This position will support day-to-day regulatory activities of assigned projects. These include providing strategic input on global regulatory strategies for pipeline products and/or life cycle management of marketed products, leading preparation and compilation of regulatory submissions, and management of regulatory submissions processes and timelines. In addition, responsibilities will include support to on-going clinical activities. Option to work remotely with occasional travel to South San Francisco will be required. Essential Duties and
Responsibilities:
Provide strategic guidance to multidisciplinary teams on the regulatory requirements to support all stages of clinical development of small molecules and/or biologics, including timely development and execution of robust global regulatory strategies Lead multidisciplinary teams in the authoring of regulatory documents, including scientific advice briefing packages, INDs/CTAs, NDAs/BLAs/MAAs, and supplements/variations Oversee and ensure compliance with regulatory procedures and work practices; support processes by which regulatory submissions are reviewed, finalized, and signed-off Proactively identify program issues and implement appropriate regulatory strategies to mitigate risks Assure compliance with project team timelines and milestones Manages and tracks queries from and commitments to regulatory agencies, collaborates with subject matter experts to provide written responses to queries, provides periodic status updates regarding unfulfilled conditions/commitments Train and mentor regulatory personnel on strategic matters, related to company and external information Maintain an understanding and awareness of existing and emerging legislation and guidelines that may affect GBT programs
Qualifications:
7-11
years of relevant experience and 5-8 years of experience in Regulatory Affairs and has earned a BS or equivalent degree; MS, MBA or equivalent may be desirable 3
years of experience leading teams and/or managing people (i.e. employees, contractors) desired for leadership positions Strong knowledge of FDA/ICH and foreign regulations and guidelines for the development of small molecule and biologic products Experience with international submissions and an understanding of worldwide small molecule / biologics guidelines and regulations is a plus Excellent organizational, interpersonal, and communication skills with the ability to build relationships at all levels of the organization Ability to work independently on multiple projects with tight timelines and minimal supervision Experience working in cross-functional, global, virtual teams Demonstrated regulatory experience in coordinating the preparation of US and international regulatory submissions Experience in eCTD format and structure Balance of strategic thinking and strong analytical skills with ability to execute High attention to detail; ability to organize, prioritize, and delegate assigned projects 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:
$100K -- $150K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
Provide strategic guidance to multidisciplinary teams on the regulatory requirements to support all stages of clinical development of small molecules and/or biologics, including timely development and execution of robust global regulatory strategies Lead multidisciplinary teams in the authoring of regulatory documents, including scientific advice briefing packages, INDs/CTAs, NDAs/BLAs/MAAs, and supplements/variations Oversee and ensure compliance with regulatory procedures and work practices; support processes by which regulatory submissions are reviewed, finalized, and signed-off Proactively identify program issues and implement appropriate regulatory strategies to mitigate risks Assure compliance with project team timelines and milestones Manages and tracks queries from and commitments to regulatory agencies, collaborates with subject matter experts to provide written responses to queries, provides periodic status updates regarding unfulfilled conditions/commitments Train and mentor regulatory personnel on strategic matters, related to company and external information Maintain an understanding and awareness of existing and emerging legislation and guidelines that may affect GBT programs
Qualifications:
7-11
years of relevant experience and 5-8 years of experience in Regulatory Affairs and has earned a BS or equivalent degree; MS, MBA or equivalent may be desirable 3
years of experience leading teams and/or managing people (i.e. employees, contractors) desired for leadership positions Strong knowledge of FDA/ICH and foreign regulations and guidelines for the development of small molecule and biologic products Experience with international submissions and an understanding of worldwide small molecule / biologics guidelines and regulations is a plus Excellent organizational, interpersonal, and communication skills with the ability to build relationships at all levels of the organization Ability to work independently on multiple projects with tight timelines and minimal supervision Experience working in cross-functional, global, virtual teams Demonstrated regulatory experience in coordinating the preparation of US and international regulatory submissions Experience in eCTD format and structure Balance of strategic thinking and strong analytical skills with ability to execute High attention to detail; ability to organize, prioritize, and delegate assigned projects 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:
$100K -- $150K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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