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Global Regulatory Lead

Location: 

Raleigh, North Carolina, United States

Job Function:  Regulatory Affairs
Job ID:  65781

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?

 

To strengthen our Global Regulatory Affairs Team, based in our RTP Office in Raleigh, NC, we are looking for a talented individual to fill the position of: Global Regulatory Leader

 

Job Summary  

  • The Global Regulatory Affairs Leader (GRL) provides regulatory leadership to assigned Mission and/or asset.  The GRL leads the global Regulatory Strategic Team (RST) for assigned projects. This role will be accountable for the global regulatory strategy and oversight of implementation/execution in alignment with the Regional Regulatory Leads and other RST members.
  • He/she is the primary contact point within UCB for any regulatory questions related to the assigned Mission and/or asset, and is informed of and supports any key (planned) interactions with health authorities. The role is also responsible for leading and coordinating Mission regulatory budget and Practice resource discussions on behalf of the PVU and the GRA practice for assigned projects.
  • In addition to having accountability for the global regulatory plans and activities, the GRL may also be involved in cross-functional activities on the Mission/PST or in multiple Missions/PST, as applicable.

 

Major Accountabilities

  • Serve as the Regulatory point of contact on the assigned Mission/PST with senior management and/or at other internal meetings providing the agreed global regulatory strategic recommendations and risk assessment for key projects.
  • May serve as the Global Regulatory representative on other relevant governance teams representing the agreed global regulatory functional view.
  • Accountable for the timely development and implementation of the global regulatory strategy and plan(s) designed to meet the needs of the business and patients for assigned Missions and/or projects (to deliver timely product milestones (e.g. HA meetings, new indications, etc.), ultimately leading to approval with a viable label meeting the needs of patients and the business).
    • Accountable for delivering all regulatory milestones related to the assigned Mission including assessment of the approvability of the program submissions together with global regulatory risk mitigation measures (supported by the regions as appropriate).
    • Accountable for the review of global/regional submission key documents (as applicable) and ensuring global alignment of key messages in line with Mission/PST objectives.
    • Identify any potential risks along with possible contingencies to ensure the most appropriate submission timing leading to the earliest possible and most optimal approval of key deliverables.
    • Accountable for ensuring the regional regulatory strategy for the specific product(s) are consistent with the business objectives, have been negotiated (if appropriate) with the appropriate regulatory authorities and that the regulatory risks have been identified.
    • Accountable for oversight of and contributing to (as appropriate) all global health authority interactions for assigned projects within the Mission/PST.  Ensures alignment of the regulatory strategy in the Mission/PST and PVU and provides adequate regulatory and technical support and supporting the team in rehearsals ensuring global alignment of key messages.
  • Participate and contribute to PVU global strategic initiatives and tactical plans related to the gathering and analyses of customer insights in the field and the consequential design/adaptation of Mission/PST business strategies.
  • Chair (can be delegated) the global Regulatory Strategic Team meeting for the Mission and/or product, to ensure prioritized objectives that focus on the critical activities are successfully delivered to time and quality
  • Lead and coordinate, on behalf of the Mission/PST, discussions around Practice resource needs and Mission regulatory budget in order to deliver Mission/PST and agreed upon GRA objectives
  • Assist in regulatory initiatives (internal or external) leading to process improvement and development of specialized expertise as needed
  • May have a dual role as the regional lead (depending on phase of project)

 

Education and Qualification

  • Bachelor’s Degree Required
  • At least 7 years’ experience in pharmaceutical regulatory affairs.
  • Knowledge of global regulatory procedures and legislation for overall drug development, regional regulatory experience, clinical trial submission, product registration, line extension and license maintenance. Global regulatory experience is a plus.
  • Global and integrated cross-functional view into pharmaceutical project management and drug development/approval and commercialization. Ability to appreciate multiple cross-functional elements contributing within drug development and ability to develop an adequate and coherent supportive global/local regulatory strategy.
  • Good track record of (contributing to) delivering regulatory approvals.
  • Direct experience in interacting with and negotiating with health authorities, including milestone meetings.
  • Knowledge of scientific foundation, sufficient to understand all aspects of regulatory issues in an authoritative way and discuss with technical experts.

 

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.


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