Regulatory Scientist
2 weeks ago
Make your mark for patients
We are looking for a Regulatory Scientist who is motivated, ambitious and eager to learn to join us in our Global Regulatory Affairs team, based in our Atlanta, GA or our Raleigh, NC offices.
About the role:
You will be responsible for preparing and delivering regulatory operational plans for allocated projects/products; project managing quality regulatory submissions to agreed project targets; providing strategic and operational regulatory input and guidance in cross-functional teams; and working flexibly within and across regions providing broad operational support to ensure the delivery of product team and business objectives.
Who you'll work with:
The Regulatory Scientist reports to the Regulatory Science Lead for the asset. You will work with the Regulatory Science Lead, the GRL, other members of the Regulatory Team and cross-functional team members.
What you'll do:
Support the GRL and Regulatory Science Lead to lead the delivery of timely approvals and product information in keeping with the needs identified by the business and markets and in compliance with relevant UCB procedures and local country regulations.Lead the planning, preparation, and delivery of both simple and complex submissions throughout the product's life cycle from either a global and/or regional perspective.Proactively liaise with the functions and participating as a member of cross-functional delivery teams for complex submissions, providing regulatory advice.Provide regulatory expertise on regulatory submissions, health authority briefing documents and response documents.Assume assigned responsibilities for routine and non-routine contact with health authorities and affiliates to support the GRL and Regulatory Science Lead.Maintain awareness of competitors' activities and share potential impact these activities may have on the product development program.Deliver project assignments supporting the business (e.g., representation on functional workstreams.)Interested? For this role, we're looking for the following education, experience, and skills:
Bachelor's Degree plus 5+ years pharmaceutical experience with knowledge of America's regional regulatory procedures and legislation.Flexibility and adaptability: Decide what to do based on the situation. Instinctively change behavior or approach to fit the situation or the person. Work effectively in ambiguous situations.Communication skills: Know when and how to communicate, using strong interpersonal and written communication skills when appropriate.Results focused, possessing the ability to overcome obstacles and achieve key outcomes.Analytical skills: Logically break situations or issues down into their essential elements, carrying out diagnosis and developing solutions.Organizational skills: Possess a high level of attention to detail.Integrity: Have an overriding commitment to integrity and high standards in self and others.Internal applicants should be in their current job for at least 12 months, must meet performance standards and are not on formal corrective/disciplinary process (PIP), warning, final warning, or compliance warning letters within the last 12 months. Please inform your Manager or your Talent Partner before applying to any internal job opportunities.
As an Equal Opportunity Employer, we are open to all talent, and adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on US- for application to US based roles. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.
Requisition ID: 87223
Recruiter: Chris Venegas
Hiring Manager: Namita Nayak
Talent Partner: Bianca Hinshaw
Job Level: MM II
Please consult HRAnswers for more information on job levels.
-
Regulatory Scientist
1 month ago
Atlanta, United States UCB Full time Make your mark for patientsWe are looking for a Regulatory Scientist who is motivated, ambitious and eager to learn to join us in our Global Regulatory Affairs team, based in our Atlanta, GA or our Raleigh, NC offices. About the role:You will be responsible for preparing and delivering regulatory operational plans for allocated...
-
Senior Principal Engineer
4 weeks ago
Atlanta, United States Hazen and Sawyer Full timeSeeking Professional Licensed Engineer with 5 – 15 years of experience in the water industry. Background and experience in municipal or industrial water, wastewater, reclaimed water, stormwater, detailed design, utility management, operations and maintenance, and/or program management are desired. Hazen and Sawyer is a stable, growing, employee-owned...
-
Recent Graduate or Near-Term Graduation
3 weeks ago
Atlanta, United States Environmental Protection Agency Full timeSummary This announcement has been amended to extend the open period to 03/27/2024, and to designate an application limit of 150. This position is in Region 4, Superfund and Emergency Management Division, Enforcement Branch, Enforcement and Cost Documentation Section. About: . This is an office-centered position*--you must physically report to the...
-
Medical Laboratory Manager
2 weeks ago
Atlanta, United States Shepherd Center Full timeShepherd Center, located in Atlanta, Georgia, is a private, not-for-profit hospital specializing in medical treatment, research and rehabilitation for people with spinal cord injury, brain injury, stroke, multiple sclerosis, spine and chronic pain, and other neuromuscular conditions. Join us in our mission to help people with a temporary or permanent...
-
Medical Laboratory Manager
1 week ago
Atlanta, United States Shepherd Center Full timeShepherd Center, located in Atlanta, Georgia, is a private, not-for-profit hospital specializing in medical treatment, research and rehabilitation for people with spinal cord injury, brain injury, stroke, multiple sclerosis, spine and chronic pain, and other neuromuscular conditions. Join us in our mission to help people with a temporary or permanent...
-
Senior Sustainability Specialist
3 weeks ago
Atlanta, United States Burns & McDonnell Full timeDescription Burns & McDonnell is looking for a Senior Sustainability Specialist to lead, scope, and coordinate sustainability program opportunities across Burns and McDonnell’s wide range of clients. This role will be key to coordinating and implementing Burns & McDonnell’s wide range of Sustainability Services. Primary Responsibilities Lead the...
-
Water/Wastewater Conveyance Engineer
1 week ago
Atlanta, United States Stantec Full timeMany of the world's top engineers and scientists come together in our Water business because they view a community's interaction with water a bit differently-as a single holistic system, rather than unconnected networks divided by jurisdictional boundaries. Working throughout the hydrologic cycle, we are delivering sustainable solutions to make sure water is...
-
(USA) Staff, SIEM Engineer
2 weeks ago
Atlanta, United States Walmart Full timePosition Summary... What you'll do... You will be joining a team that is responsible for maintaining systems that make threat detection possible. We provide a service of interrelated activities, processes, and practices that seek to prevent, identify, minimize, or neutralize cyber threats to our organization. About Team: At Walmart, we prioritize...
-
(USA) Staff, SIEM Engineer
3 days ago
Atlanta, United States Walmart Full timePosition Summary... What you'll do... You will be joining a team that is responsible for maintaining systems that make threat detection possible. We provide a service of interrelated activities, processes, and practices that seek to prevent, identify, minimize, or neutralize cyber threats to our organization. About Team: At Walmart, we prioritize innovation...
-
Atlanta, United States Wal-Mart Stores , Inc. Full timeLocation ATLANTA, GA Career Area Cybersecurity Job Function Information Security Employment Type Regular/Permanent Position Type Salary Requisition WD1820345 What you'll do at Position Summary...What you'll do...At Walmart, we prioritize innovation and data security. Our team is dedicated to maintaining a secure operating environment and preserving the trust...