Senior Manager, Regulatory Affairs - United Therapeutics
Silver Spring, MD
About the Job
California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) .
The job details are as follows:
What We Do
We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.
We are 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.
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, and other orphan diseases.
How you’ll contribute
The Senior Regulatory Affairs Manager partners with senior regulatory leadership on the development of regulatory strategy, providing regulatory advice and oversight to project teams and supporting regulatory submissions and department activities. This role serves as a Regulatory Affairs representative on project teams, interpreting issues and advising the project team on the application of regulations and guidance for pre-clinical and clinical development strategies, managing documentation needs and timelines, and supporting preparing and executing regulatory submissions. This is a hybrid position with 3 days/week onsite in our Silver Spring office and the option to work 2 days/week from home. This position has a travel expectation of up to 20%.
+ Contribute to the development and implementation of sound preclinical, clinical and CMC regulatory strategies that support the clinical and commercial development of new products
+ Manage the internal review of regulatory submissions and assures that all submissions meet the highest regulatory standards
+ Keep abreast of all applicable laws, regulations and guidance as they pertain to regulatory strategies and submissions
+ Effectively communicate regulatory needs to cross-functional teams supporting product development and regulatory submissions
+ Facilitate, prepare, and participate in meetings with regulatory agencies
+ Perform all other duties as assigned
For this role you will need
Minimum Requirements
+ Bachelor’s degree in life sciences or engineering
+ 10+ years of direct regulatory experience in pharmaceutical/biotech industry with a Bachelor's degree
+ 3+ years of experience with regulatory strategy and submissions for biologics and/or combination products
+ Experience with electronic publishing tools and electronic document management systems
+ Knowledge of domestic and international laws, regulations, and guidance that affect products under development
+ Excellent organization skills, interpersonal skills and ability to work on a number of projects with tight timelines
+ Ability to interact and communicate effectively, both verbally and in writing, with colleagues and management, both within and outside regulatory affairs, including upper management, and external government personnel
+ MS Office suite of programs, advanced knowledge of MS word
Preferred Qualifications
+ Master’s degree in life sciences or engineering and 8+ years of direct regulatory experience in pharmaceutical/biotech industry with Master's degree or
+ Doctor of Philosophy (PhD) in life sciences or engineering and 5+ years of direct regulatory experience in pharmaceutical/biotech industry with PhD/PharmD/MD
+ Regulatory Affairs Certifications (RAC)-RAPS
The salary for this position ranges from $138,000 to $175,000 per year. In addition, this role is eligible for the Company’s short-term and long-term incentive programs. Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities.
The salary range is the range United Therapeutics Corporation in good faith believes is the range of possible compensation for this role at the time of this posting depending on the candidate’s experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range. This range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
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.
Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
_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
_We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._
_We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
The job details are as follows:
What We Do
We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.
We are 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.
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, and other orphan diseases.
How you’ll contribute
The Senior Regulatory Affairs Manager partners with senior regulatory leadership on the development of regulatory strategy, providing regulatory advice and oversight to project teams and supporting regulatory submissions and department activities. This role serves as a Regulatory Affairs representative on project teams, interpreting issues and advising the project team on the application of regulations and guidance for pre-clinical and clinical development strategies, managing documentation needs and timelines, and supporting preparing and executing regulatory submissions. This is a hybrid position with 3 days/week onsite in our Silver Spring office and the option to work 2 days/week from home. This position has a travel expectation of up to 20%.
+ Contribute to the development and implementation of sound preclinical, clinical and CMC regulatory strategies that support the clinical and commercial development of new products
+ Manage the internal review of regulatory submissions and assures that all submissions meet the highest regulatory standards
+ Keep abreast of all applicable laws, regulations and guidance as they pertain to regulatory strategies and submissions
+ Effectively communicate regulatory needs to cross-functional teams supporting product development and regulatory submissions
+ Facilitate, prepare, and participate in meetings with regulatory agencies
+ Perform all other duties as assigned
For this role you will need
Minimum Requirements
+ Bachelor’s degree in life sciences or engineering
+ 10+ years of direct regulatory experience in pharmaceutical/biotech industry with a Bachelor's degree
+ 3+ years of experience with regulatory strategy and submissions for biologics and/or combination products
+ Experience with electronic publishing tools and electronic document management systems
+ Knowledge of domestic and international laws, regulations, and guidance that affect products under development
+ Excellent organization skills, interpersonal skills and ability to work on a number of projects with tight timelines
+ Ability to interact and communicate effectively, both verbally and in writing, with colleagues and management, both within and outside regulatory affairs, including upper management, and external government personnel
+ MS Office suite of programs, advanced knowledge of MS word
Preferred Qualifications
+ Master’s degree in life sciences or engineering and 8+ years of direct regulatory experience in pharmaceutical/biotech industry with Master's degree or
+ Doctor of Philosophy (PhD) in life sciences or engineering and 5+ years of direct regulatory experience in pharmaceutical/biotech industry with PhD/PharmD/MD
+ Regulatory Affairs Certifications (RAC)-RAPS
The salary for this position ranges from $138,000 to $175,000 per year. In addition, this role is eligible for the Company’s short-term and long-term incentive programs. Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities.
The salary range is the range United Therapeutics Corporation in good faith believes is the range of possible compensation for this role at the time of this posting depending on the candidate’s experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range. This range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
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.
Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
_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
_We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._
_We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
Source : United Therapeutics
