Reports To (Position): Associate Director/Director, Regulatory Science, Project Management
Location: South San Francisco, CA
Department Name: Regulatory Science
HR Designations: Pay Status – Exempt
Objective of Position
Reporting to the Associate Director Regulatory Science Project Management, the Manager/Senior Manager Regulatory Operations is responsible for end-to-end document and submission publishing, which includes planning, compiling, publishing, delivering, and archiving of regulatory submissions. This manager also coordinates printing and distribution of both paper and electronic submissions to all markets within agreed timelines and quality standards, as appropriate.
The manager is an expert in understanding Health Authority requirements regarding technical and formatting aspects of global regulatory submission publishing, and is able to guide cross functional teams through these expectations during the process.
The manager oversees Regulatory Operations and external vendors as needed, to ensure timely and compliant submissions of the highest quality, including INDs, amendments, briefing packages, and NDAs/MAAs. The manager contributes to the enhancement of publishing processes.
Essential Duties/ Responsibilities
- Performs document formatting and publishing on submission documents
- Provides expertise in management of documentation and submission components across product lifecycle
- Provides global expertise on requirements for electronic document management, submission compilation, and publishing
- Ensures regulatory documentation and submissions are compliant with health authority and/or submission standards (e.g., ICH and Health Authority Standards)
- Collaborates with regulatory on template styles and manage complex document formatting and publishing, including complicated tables and graphs
- Ensures that metadata are correctly applied so that documentation is retrievable and searchable within the electronic document management system (EDMS)
- Interacts with cross-functional team members to ensure submission deliverables, for example meets timelines
- Contributes to planning of complex submission publishing activities to multiple markets
- Authors and reviews work instructions and SOPs for department as assigned
- Manage the day-to-day budget for Regulatory Operations when required
- Establish Acerta Regulatory Operations as a true partner to AstraZeneca Reg Ops, by ensuring constant communication and creating efficiencies where possible
- At least 4 years of experience in the pharmaceutical industry, including preparation, publishing, and submissions of original eCTD IND and CTX applications
- Knowledgeable of international pharmaceutical guidances, regulations, drug development process, and industry standard practices
- Proficient user of standard MS Office suite (e.g., Word, Excel) and Adobe Acrobat applications, experience using electronic document management systems, publishing, and document review tools (e.g., eCTDXpress, documentum, ISIToolBox)
- Demonstrated ability to work collaboratively in a global team environment, to work independently, and to set and manage priorities
- Highly proficient in written, oral, and interpersonal communications in English
- High attention to detail; strong organizational, communication, and project management skills
- Ability to thrive in a rapid-paced and changing environment
- Good problem- and conflict-resolution skills
Minimum BA/BS degree, preferably in the biological or physical sciences
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be constructed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Acerta Pharma is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, or Vietnam era, or other eligible veteran status, or any other protected factor.