Job Description
Associate Director, Regional Regulatory Planning Lead
- Based in Singapore, the regional hub for Asia Pacific (AP) and top-ranked biopharmaceutical company on the Straits Times and Statista's list of Best Employers in Singapore for two consecutive years (2020, 2021).
- Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years
The Lead manages the regulatory planning of the company regulatory submission targets from a regulatory operational perspective for the whole of the Asia Pacific region.
As a member of cross-functional team and for the assigned portfolios, he/she will work with his/her team to manage all operational aspects for submission planning and execution of Original Marketing Application (OMA) and post-approval regulatory changes. The core capabilities of Regional Planning Lead include submissions planning as well as the development, implementation, and continuous improvement of business processes related to this area.
The Lead should drive the continued advancement and maturity of regional planning capabilities as well as the continuous improvement of business process and technology to meet stakeholder needs while adapting to a fast-paced regulatory environment
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 Publishing and 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:
- Bachelor 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 of evolving regulatory 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) is an 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
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us - and start making your impact today.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace
Current Employees apply
Current Contingent Workers apply
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
