Sr. Manager - Regulatory Affairs, ASPAC Region
Job Description
The Opportunity
QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.
Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.
At QuidelOrtho, we’re advancing the power of diagnostics for a healthier future for all. Join our position as Senior Manager of ASPAC Regulatory Affairs. This role provides regulatory affairs leadership and expertise to support product registrations and lifecycle management across the ASPAC region, including ASEAN country, India, Korea, Australia and Rest of Asia Country. The role is to be based in India.
We’re recruiting for a Sr. Regulatory Affairs Manager to join our team. This role provides regulatory affairs leadership and expertise to support product registrations and lifecycle management across the ASPAC, including ASEAN country, India, Korea, Australia and Rest of Asia Country. The role is to be based in India.
The Responsibilities
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.
The Key Stakeholders
Internal Customers:
Interacts with regional and corporate regulatory affairs management to provide status updates, determine priorities, and receive directives.
Interacts with direct reports to manage regulatory activities and mentor them in their professional growth.
Interacts with regional and global quality & regulatory compliance team to determine global regulatory strategy, QMS compliance and to exchange registration documents.
Interacts with regional commercial team, supply chain, marketing, service, operations, research & development, quality, and other departments to assess the regulatory impact of product changes and coordinate completion of regulatory deliverables.
Participate in cross-functional task forces and meetings between departments on specific issues.
Interacts with commercial organization and/or marketing communications in the review of advertising materials and product labeling.
External Customers:
Interacts with domestic and international agencies (and regulatory authorities) in securing marketing clearances, licenses and certificates while responding to various inquiries.
Interacts with industry associations for regulatory and policy intelligence and trending influence.
Required Skills:
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. and mentorship of staff.
Prior experience of the preparation and submission of regulatory documentation submissions, ASPAC or international registrations, and/or EU technical documentation files.
Soft Skills: 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 under minimal supervision following established procedures.
Ability to work under minimal supervision following established procedures.
Ability to handle inter/intradepartmental issues in a cooperative and diplomatic manner is required.
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.
Ability to exercise judgment within defined procedures and practices to determine appropriate action.
Proficiency with Microsoft Office, including Word, Excel, PowerPoint.
Preferred Skills:
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.