Senior Associate, Regulatory Science
Department Name: Regulatory Science
Objective of Position
Reporting to a Director/Associate Director of Regulatory Science, the Sr Associate will support day-to-day regulatory activities of assigned projects. These include support of preparation and compilation of submissions for regulatory agencies, assigned clinical studies, management of regulatory submissions processes and timelines, and regulatory tracking tools, archives, and infrastructure, as assigned.
Essential Duties/ Responsibilities
- As regulatory representative for assigned clinical studies, provides representation for study-level regulatory activities and updates in study team management meetings, supports clinical trial application activities, reviews and approves investigator document packages including FDA submissions, and manages other regulatory aspects of study as directed.
- 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 responses to Health Authority queries. Supports processes by which regulatory submissions are reviewed, finalized, and signed-off.
- Manages tracking of regulatory/ethics submissions and approvals across all studies.
- Manages document archive processes.
- Knowledgeable of international pharmaceutical guidances, regulations, drug development process, and industry standard practices.
- 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 preferred.
- BA/BS degree in the biological or physical sciences preferred.
- Relevant pharmaceutical industry experience including 1-2 years of experience in regulatory affairs. Minimum requirements are flexible.
- Proficient user of standard MS Office suite (eg, Word, Excel), experience using electronic document management systems and document review tools desirable.
PLEASE USE JOB CODE #17000 when responding with your resume.
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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. This document may be changed at management’s discretion.
Acerta Pharma is an equal opportunity employer. Acerta Pharma will consider all qualified applicants for employment, and all qualified contractors for Acerta Pharma contract positions, without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. Acerta Pharma only employs individuals, and engages contractors, with the right to work in the country/ies where the role is based.
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