| 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 Minimum Qualifications -
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%. Preferred Qualifications -
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. -
RAPS Certification. -
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 |
