Description RA Director, Enterprise MarketsYour Job You're not the person who will settle for just any role.
Neither are we.
Because we're out to create Better Care for a Better World, and that takes a certain kind of person and teams who care about making a difference.
Here, you'll bring your professional expertise, talent, and drive to building and managing our portfolio of iconic, ground-breaking brands.
In this role, you'll help us deliver better care for billions of people around the world.
It starts with YOU.
Role Overview & Primary Accountabilities:Responsible for providing Regulatory leadership for Enterprise markets that enables top line growth in by supporting regulatory initiatives, product innovation, renovation and life cycle management.
Effectively translates regulatory requirements into meaningful regulatory strategy for business leaders to support the organization's growth agenda.
This leader will act as the QRC ambassador that will provide strategic direction to the Enterprise market business to enable market access and compliance.Ensures the monitoring of the emerging regulatory requirements or guidance documents and advises product teams of the impact on the business and development programs.?Provides support to Regulatory Affairs reviewers for due diligence initiatives, including opportunity and risk assessment.?Informs senior management teams in the business or region of significant issues or developments identified during regulatory activities, as well as actions being taken to improve the situation through regular participation with regional and local teams.?Stays abreast of trends/developments in government and industry regulatory standards and requirements.
Develops strategies for ensuring K-C programs, policies and procedures meet or exceed external regulatory requirements for the Enterprise MarketSegment?Partners and influences key stakeholders at all levels of the organization with a direct impact on K-C's product portfolio and operations.?This leader is directly responsible for directing, preparing and executing all product clearances, registrations, notifications, and submissions to the appropriate regulatory bodies in the Enterprise Market Sector such as local EU, INVIMA, MOH, TFDA, submissions to ensure all regulatory requirements are met before marketing a K-C product.?Directly enables the reporting and management of critical KPIs to keep senior management informed of K-C's regulatory position, as well as provides input into QRC (Quality, Regulatory, and Compliance) Management Reviews for the regions.
Puts in place the programs, systems, structure and talent capabilities in the regions to ensure we achieve regulatory compliance.?Is accountable for the development and implementation of new Regulatory Affairs concepts or initiatives to improve the way business, project, facilities, and functions perform duties to achieve QRC objectivesAbout UsHuggies®.
Kleenex®.
Cottonelle®.
Scott®.
Kotex®.
Poise®.
Depend®.
Kimberly-Clark Professional®.
You already know our legendary brands—and so does the rest of the world.
In fact, millions of people use Kimberly-Clark products every day.
We know these amazing Kimberly-Clark products wouldn't exist without talented professionals, like you.At Kimberly-Clark, you'll be part of the best team committed to driving innovation, growth, and impact.
We're founded on 151 years of market leadership, and we're always looking for new and better ways to perform – so there's your open door of opportunity.
It's all here for you at Kimberly-Clark.Led by Purpose.
Driven by You.About YouYou perform at the highest level possible, and you appreciate a performance culture fueled by authentic caring.
You want to be part of a company actively dedicated to sustainability, inclusion, wellbeing, and career development.
You love what you do, especially when the work you do makes a difference.
At Kimberly-Clark, we're constantly exploring new ideas on how, when, and where we can best achieve results.
When you join our team, you'll experience Flex That Works: flexible (hybrid) work arrangements that empower you to have purposeful time in the office and partner with your leader to make flexibility work for both you and the business.In one of our professional roles, you'll focus on winning with consumers and the market, while putting safety, mutual respect, and human dignity at the center.
To succeed in this role, you will need the following qualifications:Essential RequirementsMin 10 years experience in Regulated Manufacturing, Quality or Regulatory Affairs roles.Bachelors Degree or Masters degree in Business, Engineering, Operations or equivalent degree.Experience in a regulatory or compliance role in a medical device, chemical, pharmaceutical, consumer goods, cosmetic or similar environment with demonstrated leadership experienceDeep subject matter expertise in regulatory compliance requirements for medical devices, pharmaceutical or cosmetics.
Interaction and experience working with various regulatory bodies across the globe as well as working knowledge of pre-market approvals (e.g., Medical Device, Consumer, Hygiene, General household, or quasi drug requirements) Experience in engagement with Agency and notified bodies to enable regional or country market access.
Ability to communicate at all levels of the organization and managing through complex compliance challenges to successful resolutionExceptional leadership skills and passion for organizational and talent development.
Strong track record of leading organizations through change and serving as an inspirational leader to the teamsExperience building a Regulatory Affairs team that proactively manages regulatory requirements while also supporting the organization's growth agendaExperience leading regulatory teams responsible for the execution of regulatory registrations, pre-market approvals, and management of regulatory/statutory inspections for multiple businesses/regionsRole model of K-C Ways of WorkingTotal BenefitsHere are just a few of the benefits you'd enjoy working in this role for Kimberly-Clark.
For a complete overview, see .
Great support for good health with medical, dental, and vision coverage options with no waiting periods or pre-existing condition restrictions.
Access to an on-site fitness center, occupational health nurse, and allowances for high-quality safety equipment.Flexible Savings and spending accounts to maximize health care options and stretch dollars when caring for yourself or dependents.Diverse income protection insurance options to protect yourself and your family in case of illness, injury, or other unexpected events.Additional programs and support to continue your education, adopt a child, relocate, or even find temporary childcare.To Be ConsideredClick the Apply button and complete the online application process.
A member of our recruiting team will review your application and follow up if you seem like a great fit for this role.In the meantime, please check out the .And finally, the fine print….Primary LocationSingaporeAdditional LocationsMalaysia - Petaling JayaWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
