Vice President of Global Regulatory Affairs
Company: Asklepios BioPharmaceutical
Location: New York
Posted on: May 24, 2020
We're looking for a candidate to fill this position in an
- Overseeing, leading and/or contributing to the development and
implementation of preclinical, clinical, CMC and regulatory
strategies for projects in all stages of development up to
marketing authorization and commercialization.
- Works cross-functionally with internal departments, including
clinical, quality, manufacturing, and third parties on Regulatory
Affairs related issues.
- Serves as a primary liaison to US FDA, EMA and other regulatory
- Defines strategies for, coordinates the execution of, and
ensures the proper archival of regulatory submissions including
Investigational New Drug (IND) applications, IMPDs, Biologics
License Applications (BLA) and Marketing Authorization Approvals
- Interprets FDA (and other regulatory bodies) communications,
expectations and decisions to internal and external stakeholders
(including CROs, CMO's, consultants and contractors), developing
and implementing successful issue resolution strategies.
- Develops strategies and drafts and/or reviews responses and
other documents intended for submission to FDA and other global
health authorities, including meeting requests, briefing packages,
fast track, orphan and RMAT applications/designations.
- Integrates global regulatory understanding and responsibilities
in developing strategy and development of regulatory submission
documents across regions.
- Contributes to the creation of the regulatory product strategy
and manages the development, monitoring and delivery of integrated
regulatory project plans throughout the product lifecycle,
including post approval.
- Manages the completion of documents and other assigned tasks
within established timelines and with high quality - in terms of
scientific content, organization, clarity, accuracy, format,
consistency and adherence to regulatory guidelines, styles, and
- Identifies and assesses regulatory risks of projects or
programs; creates scenario planning in case alternative direction
- Presents operational plans, scientific data, and strategy to
internal and external audiences, including regulators, key opinion
leaders, partners, and executives.
- Advises executive and senior management of the impact the
changing regulatory environment can/will have on company's business
- Responsible for cost-effective management of the Regulatory
Affairs department budget.
- Responsible for departmental resources, including recruitment,
deployment, professional development and management of regulatory
- Maintains and creates relevant SOPs, work instructions, and
other necessary guidance.
- Special projects as assigned.
- Advanced degree with a focus in Pharmaceutical Sciences or a
technical field highly preferred. Will consider minimum BS or an MS
degree holder: 20+(BS), 18+(MS), 14+(PhD) years of relevant and
current work experience in the fields of Regulatory Affairs,
Product Development, and/or Clinical Operations.
- 5+ years of demonstrated success in a regulatory team
leadership role and proven management by influence.
- Ability to work across diverse geographic and cultural
differences within AskBio's organization.
- Displays the highest standards of personal and professional
conduct. Supports organizational ethical standards and values
- Ability to respond quickly and accurately to
- Ability to respectfully interact with all levels of management
and departments within AskBio
- Ability to interpret, communicate and present regulatory
information clearly and concisely
- Extensive knowledge of regulations and regulatory process in US
market and preferably in global markets
- Solid understanding of regulations, regulatory processes and
dossier requirements for Biologics License Applications (BLA),
Marketing Authorization Applications (MAA) and Clinical Trial
applications (IND, IMPD, CTA) in global markets
- Must be able to think strategically and establish business
priorities with a longer-term focus based on the organization's
- Experience with global teams
- Gene therapy experience required
Keywords: Asklepios BioPharmaceutical, New York , Vice President of Global Regulatory Affairs, Executive , New York, New York
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