Regulatory Scientist

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Date: Jan 19, 2019

Location: Atlanta, Georgia, US

Help us transform patients' lives.

At UCB, we put our heart, soul, and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation.  Will you join us in our pioneering adventure?

Job Summary:

The Global Regulatory Affairs Scientist will 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

 

Key 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

 

Requirements:

  • Bachelor's Degree in a scientific discipline is required
  • PhD or Pharm D is desired
  • Minimum of 5 years of experience in a regulatory environment
  • Experience with submissions and leading and developing applications to regulators is required
  • Background in Immunology or Dermatology is desired

 

UCB is a global biopharmaceutical company. We focus on discovering and developing innovative medicines and lateral solutions that can transform the everyday lives of people with severe diseases of the immune system – or the central nervous system.

With more than 7500 people in approximately 40 countries, UCB offers an exciting working environment where initiative can flourish and those with a ‘can-do’ attitude can thrive.  Scientific excellence, innovation, co-creation, lateral thinking, reinventing the way we do things…these are some of the key competencies we are constantly developing, and looking for, at UCB.


Job Segment: Scientific, Law, Immunology, Regulatory Affairs, Scientist, Engineering, Legal, Healthcare, Science

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