- Providing dynamic regulatory leadership and guidance to project teams and working collaboratively with cross-functional team members, external contractors, vendors and consultants to identify optimum and effective regulatory strategies for assigned projects.
- Lead teams in examining regulatory strategy options, provide relevant regulatory guidance / precedents and stay abreast of the regulatory and competitive landscape.
- Identify and assess regulatory risks associated with development programs and define strategies to mitigate risks.
- Monitor and analyze regulatory agency activities in areas of interest to the company and assess potential impact on development programs. Take a global view of regulatory strategy and help teams navigate regional requirements and the potential interplay between key regulatory agencies.
- Prepare and lead teams through successful regulatory meetings and interactions.
- Lead the authoring, review and editing of high-quality, compliant regulatory documents according to specified timelines and goals.
- Lead assigned department initiatives and seek opportunities to foster interdepartmental collaboration.
- Build positive professional relationships and trust with teammates, colleagues and regulatory authority contacts.
- Assist in organization and management of staff in the RA group, including coaching, career development and oversight of work.
- Bachelor's degree in life sciences; masters or advanced degree desirable.
- 10+ years Regulatory Affairs experience in the biopharmaceutical industry or equivalent.
- Extensive knowledge of regulatory requirements and early to late-stage experience with US, EU, RoW regulatory submissions for therapeutic products and IVDs (IDE/IND/CTA/510K/PMA/BLA /NDA, etc.) in eCTD format.
- Ability to develop, understand and implement complex development strategies in the field of oncology.
- Demonstrated successful track record of interacting with regulatory health authorities and effectively moving products through the development process.
- As a member of interdisciplinary teams, ability to successfully manage multiple project deliverables, with ability to function independently in management of critical biopharmaceutical programs.
- Ability to create and manage detailed timelines and track regulatory activities across disciplines and territories.
- Experience in Pediatric, Orphan Drug, Fast Track and Breakthrough Therapy, etc. development and understanding of US, EU and RoW regulations related to these regulatory pathways.
- Prior experience in other key functional areas, (e.g., research, toxicology, pharmacology, chemistry/manufacturing, clinical research and/or biometrics).
- Strong interpersonal skills and excellent oral / written communication skills.
- Highly responsible, self-motivated professional.
- Strong leadership skills that include a desire for accountability.
- Highly collaborative working style with the ability to influence others.
- Superior work ethic that includes working autonomously with an appropriate sense of urgency and accuracy.
- Entrepreneurial orientation with the ability to effectively operate in a dynamic environment.
- Ability to problem-solve on complex issues, often in a cross-functional team setting.
- Prior experience managing direct reports, including coaching and career development.
- Excellent organizational skills that enable the successful execution of multiple simultaneous projects.
- Self-motivated, self-disciplined, and able to function independently, and in a team environment.
- High energy, enthusiasm and passion for the work.
- Proficient in various computer applications such as MS Project, Office suite, Smartsheet, etc.
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Regulatory Affairs Associate
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Senior Director, Regulatory Affairs - South San Francisco, United States - ALX Oncology Inc.
Description
ALX Oncology is a clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway. Our lead candidate, evorpacept, is a next-generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. For more information about us, please visit
We are looking for an exceptionally talented and motivated individual to join our team as Senior Director/Executive Director, Regulatory Affairs. This position will be responsible for developing and executing innovative regulatory strategies in support of the global development program for ALX148, as well as ALX's pipeline products. In this hands-on role, the successful candidate will provide dynamic leadership and guidance to multi-disciplined project teams and senior management and will work collaboratively with cross-functional team members to achieve development milestones in an efficient and compliant manner. This position will also help to develop and provide key contributions to the broader Regulatory Affairs department. The successful candidate will be required to reside within a commutable distance of our South San Francisco office. ALX Oncology Inc. follows a hybrid work model (i.e., part-time in South San Francisco office with flexibility to work part-time remotely).
We seek a self-starter with exceptional experience, leadership, communication and organizational skills. Attention to detail, as well as excellence in fostering high performing cross-functional teams and the ability to work and influence in a matrixed environment.
Responsibilities:
These include but are not limited to:
$250,000-$280,000 Senior Director
$280,000-$310,000 Executive Director
ALX Oncology is an equal opportunity employer. All applicants should be legally entitled to work for any employer in the US. Title and salary are commensurate with experience. Our compensation program includes competitive salary, equity participation and attractive bonus incentives.
Senior Director, Regulatory Affairs professionals in South San Francisco
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Kuo-Ching Chang
Data Scientist