Regulatory Scientist

 

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 youâll 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 youâll 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 productâs 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 competitorsâ 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, weâre looking for the following education, experience, and skills:

• Bachelorâs Degree plus 5+ years pharmaceutical experience with knowledge of Americaâs 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-Reasonable_Accommodation@ucb.com 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:â¯87223â¯Â 

Recruiter:â¯Chris Venegasâ¯Â 

Hiring Manager:â¯Namita Nayakâ¯Â 

Talent Partner:â¯Bianca Hinshaw

Job Level: MM II 

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