Senior Director, AP Regional Regulatory Operations

Job Description

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

Role Overview:

The Senior Director - AP Regional Regulatory Operations will be based in Singapore and report to the AVP, Regulatory Functions and Regional Operations. They will oversee all the Regulatory Operations activities in the Region to deliver high-quality, timely regulatory submissions across the regulatory portfolio.  The core capabilities of Regional Regulatory Operations include submissions planning, publishing, local labelling and artwork support, as well as the development, implementation, and continuous improvement and transformation of business processes and tools/systems in the Region.  This role will provide leadership to broader Operations, Process and Systems (OPS) organizational goals and will work in partnership with HQ/Global teams in the execution of functional capabilities.  This scope includes leading and serving as a SME to global strategic initiatives impacting the company and GRACS from global, regional and country perspective. 
 

This role is accountable for execution activities which include planning, label and artwork support and subsequent submission to Health Authorities within the Region, where appropriate, and serves as a critical partner with Regional Regulatory Teams (Regulatory Affairs International Leadership at Regional and Country levels) for meeting business objectives.   The role is responsible to manage the workload and prioritization of submissions, local label and artwork support within the region and ensure that RRO deliverables meet business objectives. 
 

This role is responsible to drive the strategic direction of the group and manage a department of colleagues to meet the current and anticipated business needs.  This role must understand the regulatory operations aspects across all the capabilities to effectively represent regulatory operations in regional activities and on the Regional Reg Affairs Leadership team.  The Regional Regulatory Operations Lead should drive the continued advancement and maturity of regional planning, publishing, local label and artwork capabilities as well as the continuous improvement of business process and technology to meet stakeholder needs while adapting to a fast-paced regulatory environment.
 

The position will sit on the AP Regulatory Affairs Leadership team which spans ~23 countries with a complex and evolving set of regulatory requirements by jurisdiction with a progressive set of regulatory operations topics advancing with Health Authorities in the region ranging from eCTD upgrades, eCTD implementations, e-Labeling as well as other digital initiatives that impact the AP region.  Further, this role and team will liaise closely with China & Japan in support of a harmonized model for global submissions.
 

What will you do:

• Represent an integrated view of AP regulatory operations functions and capabilities across the AP business.

• Serve as a trusted partner to the Associate Vice President, AP Regulatory Affairs.

• Develop and articulate a deep understanding of the business at the regional and affiliate levels.

• Ensures that global processes and systems are aligned and support the regional and affiliate constructs.

• Provide strong departmental leadership for regulatory submissions (planning & publishing) and local labeling and artwork support within the region along with effective process and tools support; Engage effectively and manage expectations with senior leaders and other cross-functional collaborations

• Establish and continually optimize processes to enable efficient and effective submission planning and publishing as well as local labelling and artwork support

• Represents an integrated GRACS OPS accountability in region across various GRACS OPS disciplines including Planning, Publishing, Systems Process & Regulatory Innovation, Labelling, as well as Innovation and Information Management

• Maintain a broad and deep knowledge of all of the submission planning and publishing activities taking place in, and supporting, the region; Contribute to the development of regulatory program strategies within the countries making up the region to ensure effective submissions planning & execution; Organize and facilitate interactions among submission planners,  submission publishers, International Labelling Support and Regulatory Liaison roles to align on urgent issues and ensure balanced workload across the region

• Shapes regulatory environment and policy drivers on topics of particular importance to regulatory operations (cloud-based submissions, data & submissions standard, etc) requiring high engagement with Health Authorities, Trade Organizations, industry peers & internal partner functions.

• Proactively identifies capabilities and capability enhancements required by the company, and works to develop strategies and business cases for funding, development and deployment

• Contributes to strategies to achieve global consistency in standards of employed systems aligned with business strategies and ensures that they are met.

• Liaise externally with counterparts in industry and industry working groups to contribute to regional and global level advancement of policy objectives impacting the submissions planning and publishing domains; Encourages a high-profile interface with associations and external groups to increase the company’s influence and ability to take advantage of a changing regulatory environment

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

• Coordinate and oversee high-level summaries of Project/Program Activities within the region for executive audiences as appropriate, including identification of risks and potential mitigations

• Ensure Project/Program data, including information used to maintain compliance, are accurately reported in Databases and understood by stakeholders.
   

People Manager for the Regional Planning, Regional Publishing, International Labeling Support and Regional Systems Process & Regulatory Innovation (SPRI) staff in the Regional Reg Ops Group

• Create an environment that attracts, develops and retains high quality employees

• Effectively foster organizational value & impact through building a high performing team

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

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

What should you have:
Bachelor’s degree in a scientific discipline required with min of 8-10 years’ experience in Regulatory Affairs with broad understanding of Regulatory Operations (submissions planning, publishing, labelling and artwork, RIM, business process improvement etc.) 
 

Regulatory Knowledge & Experience

• Deep understanding of 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

• Contributes to strategies to achieve global consistency in standards of employed systems aligned with business strategies and ensures that they are met.

• Fluent in specified languages (tied to regional specific needs)        

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)

• Region-specific regulatory knowledge (RAPS certification or in-region experience)

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

Leadership

• Strong people and interpersonal skills across all levels. Aligns teams to purpose, strategy, vision, and global goals. Adapts quickly to ambiguity and unfamiliar situations.

• Proven ability to influence, motivate, mentor, and coach teams. Uses situational leadership and creative problem-solving.

• Balances attention to detail with a big-picture view; effective with senior management.

Partnership

• Skilled at influencing, negotiating, and collaborating across functions. Service-oriented with a focus on innovation and process improvement.

• Communicates and coaches effectively across cultures and levels. Leads by influence and performs well in matrix organizations.
   

Who we are
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and everywhere else. For more than a century, we have been bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

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

Required Skills:

Preferred Skills:

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Current Contingent Workers apply HERE

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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. 

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