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Lead EMEA Regulatory Operations - Submission Planning and Publishing Job

Date: Nov 6, 2017

Location: Brussels, BE

Company: MSD

Requisition ID: REG003319

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


 


MSD is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. MRL is a true scientific research facility of tomorrow, and will take MSD’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.


 


 


The Regulatory Operations International group at MSD is currently expanding to better support the business needs of our exciting portfolio of development and marketed products. As a result, we are looking for someone to join us in this new role of Lead of EMEA Regulatory Operations – Submission Planning and Publishing.

The Lead of EMEA Regulatory Operations - Submission Planning and Publishing will report to the Executive Director, Regulatory Affairs International, and will be leading all Regulatory Operations activities in the Europe, Middle East and Africa (EMEA) Region, directly overseeing the submission planning and publishing work for the region. They will manage the team carrying out the critical tasks of submission planning and publishing within the region at our hubs in the UK and Belgium and be responsible for supporting and developing these staff to meet their greatest potential.

This role will serve as the critical contact for management across key functional areas for the delivery of timely and high quality submissions from planning through to delivery at Country Regulatory Affairs or submission to the authorities within the EMEA Region.

The person in this role will understand the workload and prioritization of submissions within the region and ensure that submissions are delivered in support of the MSD business objectives. In addition to the execution of the submissions, this role will serve as a conduit of information between the broader Global Regulatory Operations Team to the Regional Regulatory Teams.

The person in this role will be responsible for driving the strategic direction of the group and ensuring that there is capacity to meet the anticipated business needs, managing a team. The incumbent should also be able to understand the Regulatory Operations strategy across all of the functions so that they can represent Regulatory Operations in Regional activities and on the Regional Leadership team.

Primary Activities include but are not limited to:



  • Establish and continually optimize processes to enable submission planning and publishing by collaborating with Regulatory Operations HQ staff in Submission Planning, Submission Publishing and Regulatory Information Systems Management as well as regional and country Regulatory Affairs colleagues in the EMEA Region.

  • Provide strong, cross-functional team leadership for regulatory submissions and publishing within the region and manage senior leader interactions and collaborations. 

  • Coordination and oversight of high level summaries of Program Activities within the EMEA region for executive audiences as appropriate, including identification of risks and potential mitigations.

  • Demonstrate expert understanding of drug development and execution of regulatory program strategies within the countries making up the EMEA region.

  • Navigate unfamiliar territory quickly and embraces ambiguity to chart a clear course for the team.

  • Use sound judgment in determining what level of management is needed for a given -program (or given aspects of a program).

  • Mentor and coach individuals within the program on the concepts, methods and nuances of project management, MRL/ MSD processes relating to high performing teams, drug development, and regulatory practices.

  • Collaborate with other project management groups and regulatory operations functions within GRACS and across division(s) to share best practices and to ensure project deliverables are met effectively.

  • Have a good knowledge of all of the submission planning and publishing activities taking place in, and supporting, the EMEA region.

  • Organize and facilitate interactions among Submission Planners and Publishers and Regulatory Liaison roles to align on urgent issues and ensure balanced workload within the EMEA region.

  • Ensure project data, including information used to maintain compliance, are accurately reported in databases and understood by stakeholders.

  • Manage the team in the Submission Planning and Publishing groups within the EMEA Regional Regulatory Operations Group (currently 3 submission planners - UK and a Submission Planning Manager (team of 4 planners) and Submission Publishing Manager (team of 2 publishers) in Brussels)

  • Mentor and coach teams (both direct reports and project) to ensure the following:
    o Timelines are appropriately managed with a clear understanding of dependencies and critical path.
    o Proper negotiation with end-to-end stakeholder timelines to ensure alignment and realistic timeframes for execution.
Qualifications

Education Minimum Requirement:



  • Bachelor’s degree required

Required Experience and Skills:



  • Min of 8-10 years’ experience in Regulatory Affairs and/or Regulatory Operations, with at least 3 years’ experience in either submission planning or submission publishing.

  • Proven experience as a leader on teams and able to influence and motivate team members and Senior Management.

  • Requires strong interpersonal, influence, and negotiation skills across all levels.

  • Deep understanding of regulatory submission standards, submission procedures and drug development landscape across the EMEA Region.

  • Proven experience in working in and leading cross functional teams to ensure high quality, on-time submissions.

  • Effective at energizing others, establishing clear goals, mentoring and coaching within a team setting.

  • Demonstrated situational leadership and creative problem solving within organizations and teams.

  • Demonstrated ability to collaborate, communicate, supervise and coach across cultures, organizational levels and disciplines.

  • Ability to lead by influence and work effectively in matrix organizational structures.

  • Ability to understand details, but keep overall "big picture" view of projects and strategies.

Desired Experience and Skills:



  • Expert in project management methodologies (e.g. PMP, Sigma, Change Management, etc.) and associated toolsets (e.g. MS Project for project planning, MS Excel for data analysis and reporting) 

  • Advanced degree preferred (engineering or scientific discipline, MBA)

Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.


 


Search Firm Representatives Please Read Carefully:
MSD is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of MSD. No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.



Job: Regulatory Affairs Generic
Other Locations:
Employee Status: Regular
Travel: Yes, 20 % of the Time
Number of Openings:
Shift (if applicable):
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Company Trade Name: MSD


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