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Let's push the boundaries together and make the most of your talents!

Regulatory Science Lead

Location: 

Smyrna, Georgia, United States

Job Function:  Regulatory Affairs
Job ID:  65233

Help us transform patients' lives.

At UCB, we put our heart, soul and skills into making a difference for people living with significant unmet needs. Working together, we blend the best of our talents to deliver thoughtful solutions that patients value. Will you join us in this pioneering adventure?

Job Summary  

  • Prepare and deliver regulatory operational plans for assigned projects/products within a specific region. Provide strategic and operational regulatory input and guidance in cross-functional teams. Manage quality regulatory submissions to agreed project targets. Work flexibly within and across regions to provide broad operational support to ensure the delivery of product team and business objectives.

 

Major Accountabilities

  • Support the Global Regulatory Leader (GRL) for 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 regional/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.
  • Liaise proactively with the functions and participate as a member of cross-functional delivery teams for complex submissions, providing regulatory advice
  • Identify potential regulatory risks to the operational plan, and propose options to mitigate risks.
  • 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.
  • Maintain awareness of competitors’ activities and share potential impact these activities may have on the product development program
  • Delivers project assignments supporting the business e.g. representation on functional workstreams
  • Ensure that appropriate, up-to-date records are maintained for compliance
  • Assist in development of regulatory standards and SOPs
  • Provide input into Regulatory Strategy Plans and project budget as delegated by GRL
  • Assist in due diligence activities for in-licensing opportunities

 

Education and Qualification

  • Bachelor degree required
  • 5+ years pharmaceutical experience with knowledge of assigned regional regulatory procedures and legislation

 

Competencies

  • Build effective partnerships – identifies opportunities and takes actions to build effective relationships within team and with other areas
  • Influencing skills - through well thought through rationale and effective communication skills, able to influence key decisions
  • Flexibility and adaptability - Decides what to do based on the situation. Changes behavior or approach to fit the situation or the person.  Works effectively in ambiguous situations.
  • Communication skills – knows when and how to communicate, using strong interpersonal skills and written communications when appropriate
  • Results focused – ability to overcome obstacles and achieve key outcomes
  • Analytical – logically breaking situations or issues down into their essential elements: carrying out diagnosis and developing solutions
  • Organizational Skills
  • Integrity – overriding commitment to integrity and high standards in self and other

 

 

About Us

At UCB, we come together every day to work, laser-focused, on a simple question: How will this create value for people living with severe diseases? By putting patients at the heart of everything we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees worldwide operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases. We are looking for people with passion and empathy who develop a real understanding of patient’s needs and can deliver thoughtful solutions to decisionmakers across the heath care ecosystem.

Curious to know more? Please visit our website www.ucb.com.

 

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.


Job Segment: Regulatory Affairs, Neurology, Immunology, Medical, Law, Legal, Healthcare

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