Senior Manager - Regulatory Affairs, ASPAC Region

QuidelOrtho

Senior Manager of ASPAC Regulatory Affairs in a leading in vitro diagnostics company. Providing regulatory leadership for product registrations and lifecycle management across the ASPAC region.

Posted 6/16/2026full-timeMumbai • 🇮🇳 IndiaSeniorWebsite

About the role

Key responsibilities & impact

Provide regulatory guidance to global and regional commercial teams to support new product introductions, market expansions, and lifecycle management
Determine regulatory pathways, risk classifications, and submission requirements for each country
Lead and support regulatory budget and expense management, including optimization of submission strategies, resources/consultant usage, and local testing processes
Prepares regulatory documentation to support domestic and regional product submissions and registrations
Liaises with global corporate regulatory partners for in-country submissions as necessary
Evaluates and response change control documents for impact on regulatory submissions and filing requirements, as well as associate cost & lead-time in timely manner
Implements, manages, and continuously improves related regulatory processes, tools, and trackers to improve project management accuracy and efficiency
Manage interactions with local regulatory authorities through distributors and/or consultants (associations), ensuring timely responses to questions, deficiencies, and renewals
Monitor regulatory changes and emerging requirements in assigned markets, communicating risks and opportunities to business partners
Support regional tender processes as need
Manages Enterprise system entries for regional trade compliance and legal distribution of product
Establishes and/or owns regulatory affairs processes and represented as subject matter expert during regulatory inspections and QMS compliance
Ensure regulatory records and historical filing are complete and well organized
Develops and presents training materials for regulatory requirements and/or department processes for continuous improvement
Perform other work-related duties as assigned

Requirements

What you’ll need

Bachelor's degree (BS/BA) in a scientific discipline, pharmaceutical, biological, Chemistry, biotechnology, medical engineer or related is preferable
Advanced degree an asset (MSc, PhD)
12+ years' prior experience in the IVD (in vitro diagnostic), medical device or bio/pharma industry
6 years+ prior regulatory affairs experience (or related educational/work experience) with progression of responsibility and leadership
Prior experience of the preparation and submission of regulatory documentation submissions, ASPAC or international registrations, and/or EU technical documentation files
Strong project management, problem solving, communication, and negotiation skills
Demonstrated ability to lead a high-performing regulatory affairs team
Prior direct interaction with ASPAC regulatory authority or other regulatory agencies, as well as trade association for regulatory intelligent/influence potential
Demonstrated ability to understand and make decisions for complex situations
Demonstrated leadership skills
Must possess a high degree of accuracy and attention to detail
Ability to work independently and be self-motivated
Ability to work on assignments of high visibility where independent action and a high degree of initiative is needed in resolving problems and developing recommendations
Ability to work on multiple projects simultaneously and manage budget with level of accuracy, make adjustment basis per changes
Proficiency with Microsoft Office, including Word, Excel, PowerPoint
Advanced knowledge of current and evolving regulations for medical device (IVD) approval
Advanced knowledge of quality systems and GMP
Excellent written and verbal interpersonal skills to influence many diverse internal/external customer groups, business stakeholders
Ability to support Clinical, R&D, V&V, and PMO departments as needed

Benefits

Comp & perks

Provide regulatory guidance to global and regional commercial teams to support new product introductions
Determine regulatory pathways, risk classifications, and submission requirements for each country
Lead and support regulatory budget and expense management, including optimization of submission strategies, resources/consultant usage, and local testing processes
Prepares regulatory documentation to support domestic and regional product submissions and registrations
Liaises with global corporate regulatory partners for in-country submissions as necessary
Evaluates and response change control documents for impact on regulatory submissions and filing requirements, as well as associate cost & lead-time in timely manner
Implements, manages, and continuously improves related regulatory processes, tools, and trackers to improve project management accuracy and efficiency
Manage interactions with local regulatory authorities through distributors and/or consultants (associations), ensuring timely responses to questions, deficiencies, and renewals
Monitor regulatory changes and emerging requirements in assigned markets, communicating risks and opportunities to business partners
Support regional tender processes as need
Manages Enterprise system entries for regional trade compliance and legal distribution of product
Establishes and/or owns regulatory affairs processes and represented as subject matter expert during regulatory inspections and QMS compliance
Ensure regulatory records and historical filing are complete and well organized
Develops and presents training materials for regulatory requirements and/or department processes for continuous improvement
Perform other work-related duties as assigned

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory documentation preparationregulatory submissionsrisk classificationproject managementbudget managementregulatory pathwaysquality systemsGMPIVD approvalregulatory compliance

Soft Skills

communicationnegotiationproblem solvingleadershipattention to detailindependent workinitiativetime managementteam managementinterpersonal skills