MSD Associate Director Regional Regulatory Planning Lead 

Singapore, Singapore 

499420133

Job Description

Associate Director, Regional Regulatory Planning Lead

• Based in Singapore, the regional hub forAsia Pacific (AP)andtop-ranked biopharmaceutical company on the Straits TimesandStatista’s list of Best Employers in Singapore for two consecutive years (2020, 2021).
• Join thepremier biopharmaceutical companythat has beenin Singapore for more than 25 years and in AP for over 60 years

This position requires a high-level expertise and knowledge of the regulatory landscape across the Asia Pacific Region its registration procedures and a thorough understanding of the technical requirements for dossiers.

WHAT YOU WILL DO

Primary Activities include but are not limited to:

• Provide strong, cross-functional team leadership for regulatory submissions within the region and manage senior leader interactions and collaborations.
• Maintain a broad and deep knowledge of all the submission planning activities taking place in his/her assigned portfolio.
• Contribute to the development of regulatory program strategies within the Asia Pacific markets to ensure effective submissions planning & execution.
• Organize and facilitate interactions among submission planners and publishers and Regulatory Liaison roles to align on urgent issues and ensure balanced workload across the region
• Manage regulatory projects from authorization through delivery to country regulatory affairs teams and/or Health Authorities, with a regulatory operations perspective.
• Responsible for developing and maintaining the regulatory submission plan for the assigned key projects/products and maintaining the related project milestones.
• Lead or participate in cross-functional forums and meetings
• Work closely with the central planner based in the HQ (US) on assigned products/projects.
• Drive continuous improvement of business process and technology within the Regional Planning, Regional Publishingand regulatory system teams
• Ensure robust functional area oversight of sourced activities to ensure quality, compliance and delivery against key performance criteria.

People Manager for the Regional Planning, team:

• Manage the staff in the Regional Reg Ops Group providing oversight to FTEs, contractors and sourced planning, resources as per business needs.

• Mentor and coach individuals within the department on the concepts, methods and nuances of project management, publishing, and company processes relating to high performing teams, drug development, and regulatory practices.

WHAT YOU MUST HAVE

To be successful in this role, you will have:

• Bachelors degree in a Life Science related discipline.
• Min of 6-8 years’ experience in Regulatory Affairs with at least 3 years in Regulatory Operations (submissions planning, publishing, etc)
• Leadership:
  • Strong people and interpersonal skills to manage effectively across all levels.
  • Navigates unfamiliar territory quickly and embraces ambiguity to chart a clear course for the team
  • Effective at mentoring and coaching within a team setting
  • Demonstrated situational leadership and creative problem solving within organizations and teams
• Partnership:
  • Demonstrated strong partnering skills in influencing and negotiating across functions
  • Service delivery mindset driven by continual innovation and process improvements
  • 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
  • Excellent communication skills to manage interactions with colleagues in a multicultural environment.
• Regulatory Knowledge & Experience
  • Deep understanding ofevolvingregulatory submission standards, submission procedures and drug development landscape across the Region
  • Proven experience in working in and leading cross functional teams to ensure high quality, on-time submissions
  • Able to multitask with proven project management capabilities including managing dynamic timelines, interacting, and negotiating with others, collaboration skill and excellent follow-up ability
  • Capability to keep overview in the complexity of planning, managing, tracking, assembling and delivering of regulatory content, to meet regulatory strategy, regulatory compliance and informational needs for internal and external customers.
  • Thorough knowledge of regulatory guidelines and procedures within the AP region is required and knowledge of submissions in the wider region (China and Japan) isan advantage
  • Affinity to work with complex IT systems,automation
  • Ability to handle time pressure and the consequence of any delay in timely submissions.

WHAT YOU CAN EXPECT

• Learning curve and a diverse opportunity
• Fulfilling role, exposure to various Asia Pacific markets, cutting-edge therapeutic areas in Oncology and precision medicines
• Will be involved in driving process improvement projects through process simplification and automation through artificial intelligence, robotic automation
• Leadership opportunity:
  

What we look for…

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.