Sirnaomics, Inc. is a leading clinical stage biopharmaceutical company in the discovery and development of RNAi therapeutics for treatment of cancer and fibrotic diseases. We are seeking candidates to fill the newly created position of Sr. Manager/Manager of Regulatory Affairs for our headquarters in Gaithersburg, MD.
The well-qualified candidate will prepare, track, and assess regulatory documents for submissions, and will be responsible for developing and maintaining templates, files and archives for regulatory correspondence and submissions, in compliance with regulatory affairs department or company policies, practices and procedures.
Requirements & Responsibilities
Prepare, track and assess regulatory documents for submissions.
Develop and maintain templates, files and archives for regulatory correspondence and submissions, in compliance with regulatory affairs department or company policies, practices and procedures.
In collaboration with the Head of Regulatory Affairs, develop functional area practices, policies and procedures and facilitate their implementation.
Serve as day-to-day internal operational lead for the assigned Regulatory Affairs functions and project(s) and collaborate with external consultants and vendors to achieve project goals for regulatory affairs activities.
Assist in preparing teams for regulatory agency interactions.
Prepare INDs, NDAs, CTAs, MAAs, annual reports, amendments and correspondence as well as participating in the development of meeting briefing information and other documents for regulatory agency meetings.
Provide document formatting, preparation and quality assessment of documents for regulatory submissions.
Identify regulatory issues proactively that may impact the assigned project(s) and discuss strategies to address them with the VP of Regulatory Affairs.
In collaboration with the VP of Regulatory Affairs, the Senior manager/Manager will provide the project team(s) for assigned project(s) with advice on potential regulatory affairs requirements, potential issues, regulatory options, procedures and practices based upon research into relevant regulatory requirements and guidance, as well as clinical practice guidance relevant to the preparation and submission of regulatory documentation.
Education & Experience
Bachelor’s degree, or equivalent, in biological science, nursing, pharmacy or related discipline is required. An advanced degree is preferred.
Five or more years of related experience required (7 or more for the Senior Manager level), to include experience managing regulatory submissions and/or projects, to include the management of complex, multi-stakeholder projects and achieving goals is strongly preferred.
Demonstrated experience overseeing multiple vendors of various types is desirable.
Demonstrated experience in the identification of emerging regulatory risks (consistent with experience).
·Demonstrated experience collaboratively working within a multi-disciplinary drug development team to help resolve challenges.
Excellent written and verbal communication skills (bilingual in Mandarin and English desirable but not required).
Demonstrated ability to conduct responsibilities with high level oversight and competency and ability to drive forward work on own initiative.
Diplomatic style to drive collaboration in a multi-stakeholder environment.
Experience in multi-cultural professional environments.
Energetic, service- and goal-oriented style.
Develop and maintain excellent knowledge of regulatory procedures and environments; establish rapport and engage with regulatory agencies on project-related matters for assigned project(s), as requested.
Stay abreast of the regulatory environment through active participation in conferences and training.
Sirnaomics, Inc. is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender-identity, national origin, disability status, protected veteran status, genetic characteristics or any other characteristic protected by law.
Sirnaomics, Inc. is a Maryland based clinical stage biopharmaceutical company.
We are forging a path to high value creation through discovery and development of therapeutics for human disorders with unmet medical needs through our proprietary Polypeptide Nano-Particle (PNP) technology for small interfering RNA (siRNA) drug delivery. This technology allows accessing the tumor micro-environment (TME), as well as various cell types in the liver. The clinical development pipeline is focused on oncology and fibrosis indications.