Reports To (Position): Associate Director/Director, Regulatory Science
Location: South San Francisco, CA
Department Name: Regulatory Science
HR Designations: Pay Status – Exempt
Objective of Position
Reporting to the Associate Director/Director of Regulatory Science, the Associate/Senior Associate/Manager will cover day-to-day regulatory activities of assigned projects. These activities include preparation and compilation of submissions for regulatory agencies, serving as regulatory representative for assigned clinical studies, management of regulatory submissions processes and timelines, and oversight of various regulatory tracking tools, archives, and infrastructure, as assigned.
Essential Duties/ Responsibilities
- Collaborates with the Project Team representatives in compilation of submissions to regulatory agencies, including coordination with regulatory operations group. For larger submissions, collaborates with project management organization to set and track submission timelines.
- As regulatory representative for assigned clinical studies, provides representation for study-level regulatory activities and updates in study team management meetings, oversees clinical trial application activities, reviews and approves investigator document packages, and manages other regulatory aspects of study as directed.
- In collaboration with the Associate/Sr Associate when assigned, manages and tracks queries and commitments with regulatory agencies, collaborates with subject matter experts to provide written responses to queries, provides periodic status updates regarding unfulfilled conditions/commitments.
- Collaborates with Project Team representatives in planning of regulatory documents, including authorship of discrete document sections, definition of review cycles, as well as adjudication of review comments, as assigned. Oversees process by which regulatory submissions are reviewed, finalized, and signed-off.
- Builds effective partnerships – identified opportunities and takes actions to build effective relationships within team and with other areas
- With the support of the Associate/Sr Associate when assigned, manages tracking of regulatory/ethics submissions and approvals across all studies.
- Provides regulatory review of clinical, nonclinical, manufacturing, and regulatory documents as directed.
- Conducts regulatory intelligence on therapeutic landscape and regulatory developments, provides updates to regulatory and project teams as needed.
- Authors and reviews work instructions and SOPs for department as assigned.
- Consistently complies with all governing laws, regulations, Acerta Pharma SOPs and all other guideline relevant to our business
- Has personal responsibility for maintaining a culture of high competence, creativity and close collaboration within Regulatory Science, and with other functions
- Minimum BA/BS degree in the biological or physical sciences. PharmD, PhD or equivalent is a plus.
- A minimum of 3 years of experience in the biotech/pharmaceutical industry and 3 years of experience in regulatory affairs is preferred. Minimum requirements are flexible for candidates holding advanced scientific degrees.
- Knowledgeable of international pharmaceutical guidances, regulations, drug development process, and industry standard practices.
- Highly proficient in written, oral, and interpersonal communications in English.
- Ability to work in close collaboration with colleagues in regulatory department and throughout the development organization.
- High attention to detail; ability to organize, prioritize, and delegate assigned projects.
- Experience interacting with CROs in the management of US eCTD IND submissions and ex-US CTAs towards clinical trial activations.
- Proficient user of standard MS Office suite (eg, Word, Excel), experience using electronic document management systems and document review tools desirable.
To apply for this position, please send your resume to firstname.lastname@example.org
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 construed 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.