How you’ll contribute The Regulatory Affairs Associate supports the company with the preparation, compilation, review, distribution, and archiving of regulatory dossiers that are associated with genetically engineered (GE) pigs. The position requires an understanding of new and existing regulations as it pertains to the FDA’s Center for Veterinary Medicine (CVM) New Animal Drug Application (NADA) process and leverages this knowledge in all aspects of Revivicor’ s verbal and written communication to staff, project teams, internal stakeholder, external investigators, regulatory bodies or any other relevant party.
Key job responsibilities
Assist with the preparation and maintenance of new and existing regulatory applications including investigational and marketing applications (INADs, NADAs) including amendments, supplements, , pharmacovigilance-related submissions, product registration, post-approval reports, and any other submissions in compliance with health authority regulations.
Archive and maintenance of associated regulatory files, specifically in preparation of an audit by a regulatory agency
Reviews marketing, legal, and technical documentation such as new investigator submissions, protocol revisions, case files and clinical research reports to assess compliance
Interacts with various regulatory agencies, contract groups, and partner organizations, as necessary, to carry out regulatory functions.
Responsible for preparing and maintaining meeting agenda and minutes of assigned regulatory projects.
Recommends remediation to facilitate company to achieve the appropriate level of compliance
Conducts internal audits of products and protocols to identify areas of weakness, and, if appropriate, implements corrective measures. Regularly reports on compliance status and measures to both internal and external parties
Prepares for and facilitates third-party audits as necessary
Collaborates with staff to ensure appropriate level of compliance to regulations, procedures, and policies through all phases of product development including discovery, research and development, manufacturing, marketing, and final approval.
Collaborates with the initiation, planning, directions, execution, and summary of scientific studies that are intended for review by regulatory authorities and critical to corporate regulatory strategy, tactics, or operations. Studies may be in vitro or in vivo studies in laboratory animals conducted internally or via external collaborators or service providers.
Perform other duties as assigned.
For this role you will need
Bachelor's degree, preferably in a science related field.
Minimum of 3 years experience in the pharmaceutical/biotech industry.
Impeccable technical writing and presentation skills.
Excellent organizational, multitasking, and communication skills .
Proficiency with MS Office Suite.
Broad understanding of the FDA’s regulatory processes
Ability to travel up to 20%.
MS or Ph.D. in biochemistry, microbiology, virology, or epidemiology.
At least 3-years direct experience with regulatory affairs.
Background and experiences in infectious diseases, and infectious disease testing including bacteria, viruses, fungi, and yeast.
Diverse experience including biologics, drugs and medical devices
Contributions to scientific literature via journal articles, conference abstracts or presentations.
Familiarity with FDA eCTD systems.
Experience and comfort working independently and as part of a team on multiple projects with ability to prioritize effectively.
Strong attention to detail and project completion.
Life as a Unitherian
At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
Employer will assist with relocation costs.
Internal Number: RO2056
Revivicor is a subsidary of United Therapeutics Corporation and focuses on the strength of a balanced, value-creating biotechnology model. We are confident in our future thanks to our fundamental attributes, namely our commitment to quality and innovation, the power of our brands, our entrepreneurial culture and our bioinformatics leadership. We also believe that our determination to be responsible citizens — having a positive impact on patients, the environment and society — will sustain our success in the long term.
We currently have five approved products on the market and a long-term mission of providing an unlimited supply of transplantable organs for those who need them.
Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, pediatric cancers and other orphan diseases.