Regulatory Affairs Associate/ Senior Regulatory Affairs Associate Job at United Therapeutics
The job details are as follows:
What We Do
United Therapeutics Corporation 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.
In 2021, we became the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.
How you’ll contribute
Assist with the preparation, compilation, and review of regulatory submissions and related regulatory documents. Collaborate with manager, project teams, and functional area representatives to implement sound regulatory strategy.
Support the preparation and maintenance of new and existing regulatory applications including investigational and marketing applications (IND/CTAs, NDAs, MAAs, etc.), amendments, supplements, orphan applications, pediatric investigational plans, and other submissions in compliance with health authority regulations- Perform regulatory review of essential documents, clinical protocols/reports, informed consents, investigator brochures, and investigational medicinal product dossiers in support of new and active clinical studies to ensure consistency with related filings and regulatory requirements
- Interact regularly with UTC product development groups (e.g., nonclinical, clinical, quality, marketing, safety, medical) on project teams
- Execute regulatory strategy on assigned projects
- Responsible for the submission and tracking of individual case safety reports to UTC-sponsored applications
- Support other regulatory and compliance activities as required, working closely with project teams and other regulatory personnel
- Learn and navigate UTC eCTD systems as needed
- Perform other duties as assigned
For this role you will need
Minimum Requirements - Associate Level
- Bachelor’s Degree in Arts/Sciences (BA/BS) in a science related field
- 2+ years of direct experience with regulatory affairs preferred; or advanced degree and equivalent industry and regulatory affairs experience considered
- Strong technical knowledge and proficient in use of MS Office
Preferred Qualifications
- Experience with electronic publishing tools (eCTDs), electronic document management systems, or other specialized software used within the pharmaceutical industry strongly preferred.
- Knowledge of FDA regulations/guidance, ICH, GCP and/or GMP standards
Minimum Requirements - Senior Level
- Bachelor’s Degree in Arts/Sciences (BA/BS) in a science related field
- 5+ years of experience in the pharmaceutical/biotech or related industry
- 3+ years of direct experience with regulatory affairs preferred; or advanced degree and equivalent industry and regulatory affairs experience considered
- Experience with electronic publishing tools (eCTDs), electronic document management systems, or other specialized software used within the pharmaceutical industry strongly preferred
- Strong technical knowledge and proficient in use of MS Office
- Strong attention to detail and project completion
Preferred Qualifications
- Regulatory Affairs Certifications (RAC)-RAPS
- Knowledge of FDA regulations/guidance, ICH, GCP and/or GMP standards
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.
While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients.
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities
Please Note :
apexdining.ca is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, apexdining.ca provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.