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Lead of APAC Reg Ops - Submission Planning and Publishing

Lead of APAC Regulatory Operations - Submission Planning and Publishing

The Lead of Asia Pacific Regulatory Operations -Submission Planning/Publishing will be the lead for all Reg Ops activities in the APAC Region overseeing the submission planning and publishing work for the region. 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 RA or submission to the authorities within the Asia Pacific 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 company's 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 in the group to meet the anticipated business needs and manage a small team of direct reports. The person in this role should also understand the Reg Ops strategy across all of the functions business areas so that they can represent Reg Ops in Regional activities and on the Regional Leadership team.

Primary Activities include but are not limited to:
* Establish and continually optimize processes to enable efficient processes for submission planning and publishing by collaborating with Reg Ops HQ staff in regional and country RA staff in the AP 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 APAC 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 APAC 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, company 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 AP 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 AP region
* Ensure project data, including information used to maintain compliance, are accurately reported in databases and understood by stakeholders.
* People Manager for the Planning and Publishing Staff in the Regional Reg Ops Group
* Manage the staff in the APAC Regional Reg Ops Group (planned to be 1 Regional Planner, 1 Submission Publisher and 1 Regulatory Systems Business Analyst), and provide oversight to sourced planning, publishing and system support resources.
* Mentor and coach teams (both direct reports and project) to ensure the following:
* Timelines are appropriately managed with a clear understanding of dependencies and critical path
* Proper negotiation with end-to-end stakeholder timelines to ensure alignment and realistic timeframes for execution

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.
* Requires strong interpersonal, influence, and negotiation skills across all levels.
* Proven experience as a leader on teams and able to influence and motivate team members and Senior Management.
* Deep understanding of regulatory submission standards, submission procedures and drug development landscape across the APAC 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)

If you are interested in discussing further on the opportunity in a confidential manner, or other Regulatory Affairs opportunities in the pharmaceutical and medical devices industry, please contact Jennifer Ha at j.ha(@)realstaffing.com or contact +65 6871 4700.

Real, a trading division of SThree Pte Limited (Registration Number: 2007.20126E | SThree Pte Limited Licence Number 16S8216 | Real Licence Number 53132073A)

Award winner of:
* International Recruitment Company of the Year by Recruitment International 2016
* Life Sciences and Healthcare Recruitment Company of the Year by Recruitment International 2016
* Best Overseas Operation by Gloabl Recruiters 2017

Monthly Salary: SGD 16000

Application Email: JIHA.87522.3273@sthreesg.aplitrak.com
To be eligible to apply for this position you must be a Singapore Citizen or Authorized to work in Singapore.

Job Summary

Category & Subcategory:
Healthcare and MedicalPharmaceuticals
Salary: $16,000 - $16,000 / month
Location: Central Area
Work Type: Full Time
Career Level: Not Specified
Education: Not Specified
Experience: Not Specified
Ref Number: RE-32784191
Date Posted: Feb 01 2018
Advertiser: Real Life Sciences