- The Senior Manager /Associate Director, Regulatory Affairs will develop and implement global regulatory strategies to support the development of multiple oncology early development assets. This role provides leadership in the strategic guidance and execution of regulatory concepts within cross-functional project teams and supports interactions with global health authorities and corporate partners with regulatory deliverables.
location: Redwood City, California
job type: Contract
salary: $95.00 - 108.01 per hour
work hours: 9 to 5
- Develop and implement competitive and effective global regulatory strategies for various oncology products including clinical, nonclinical and CMC aspects and identify potential risks associated with proposed strategies
- Manage and participate in the creation, review, assembly and submission of regulatory documentation such as INDs and its international equivalents, expedited program designations, orphan drug applications, annual reporting, pediatric plans, and amendments related to clinical trials
- Coordinate and consult with subject matter experts on the content, review of publication/promotional materials, and assembly of regulatory documentation
- Serve as primary Health Authority contact for assigned projects
- Provide advice and guidance to project teams on the interpretation and application of relevant regulatory requirements and review processes.
- Present global regulatory strategies and issues at team or governance meetings
- Collaborate with regional and country regulatory affiliates to support international development activities
- Coordinate and prepare for Health Authority meetings and associated briefing document preparation
- Attend relevant functional area and project team meetings, including nonclinical, clinical, and regulatory sub teams
- Bachelor degree in a life sciences, chemistry, or related discipline. Advanced degree preferred
- 6 to 8 years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the regulatory environment. International regulatory experience preferred
- Knowledge of current US and EU regulations, including experience preparing, filing, and performing life-cycle management of applications and all supportive amendments, supplements, and annual reports to the United States Food and Drug Administration (US-FDA) in eCTD format
- Knowledge of global clinical trial regulations, including experience with submission of Clinical Trial Applications (CTAs) to global regulatory agencies and management of regulatory aspects of clinical trials in accordance with Good Clinical Practices (GCP) requirements
- Experience in submissions of Proposed Pediatric Study Request (PPSR), deferral requests, study protocols and clinical study reports (CSRs)
- Experience with health authority meeting preparation
- Proven ability to independently manage critical projects as part of an interdisciplinary team. In addition, the candidate should have experience preparing, managing and submitting major regulatory submissions.
- Ability to successfully manage multiple projects to deadlines
- Experience with regulatory intelligence activities and pharmaceutical registration databases to support product approval strategies
skills: Regulatory Affairs Operations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.