Senior Regulatory Operations Analyst
Job Description
Your Job
You’re raising the stakes for your career to do more. Learn more. Impact more. Here, your innovation, ideas, and technical curiosity will help us deliver better care for billions of people worldwide. You’ll put your professional expertise, talent, and drive to work by building and managing our portfolio of iconic brands, which in turn helps billions of people around the world. It starts with YOU.
About Us
Huggies®. Kleenex®. Cottonelle®. Scott®. Kotex®. Poise®. Depend®. K-C Professional®. You already know our legendary brands—and so does the rest of the world. In fact, 25% of people in the world use Kimberly-Clark products every day, and it takes the absolute best people to make that happen.
We’re founded on 150 years of market leadership, and we’re always looking for new and better ways to perform, especially when it comes to product and process innovation. Our customers are always looking for new and better. Our competitors won’t stop evolving. And our communities demand responsible corporate practices. We need bold, transformative ideas from people who can turn them into reality. That means there’s no time like the present to make an impact here. It’s all waiting for you at Kimberly-Clark; you just need to log on!
Led by Purpose, Driven by You.
About You
You’re driven to 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’re also a university graduate with a degree in Sales or a related area and have at least 7 to 10 years of continuous work experience. 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.
Job Description
Expectations and Responsibilities:
- Implement programs and procedures to ensure effective Safety and Quality attitudes and practices.
- Ensure that all elements of the Corporate Code of Conduct are fully supported.
- Ensure that all elements of the Corporate Human Resources Development and Diversity policy are fully supported.
- Manage self in accordance with the expected behaviors of the Leadership Qualities associated with this role.
- Execute all regulatory activities in accordance with corporate policies and practices, protection of proprietary information, and compliance with applicable laws and regulations.
- Communicate appropriately with all customers, conducting all communications and transactions with the utmost integrity.
Principle Accountabilities:
- Support management of the information systems, databases, and system integration to support local and global regulatory affairs.
- Supports regulatory information management system governance processes and regulatory data management (systems, tools, documents, records, and standards).
- Support regulatory training program and materials.
- Maintain the lifecycle management of product registration and re-certifications activities prior to expiration dates.
- Maintain global regulated product list and track applicable regulatory requirements, certification, registration, and re-certification activity.
- Support activities related to regulatory import/export documentation including Power of Attorney (POA’s), Certificates of Free Sale, etc. document creation and management to effectively register products.
- Develop and maintain an appropriate regulatory governance process to track and monitor regulatory system health. Report on key performance indicators or other metrics for GRA.
- Manage regulatory document management database which includes regulatory procedures, work instruction and job aids.
- Responsible for developing and maintaining adequate procedures at every level within the regulatory affairs organization to ensure the effective execution of regulatory processes.
- Maintain adequate standard work processes to support the technical regulatory team.
- Support Quality System activities related to product release and product disposition activity.
- Assist projects to improve regulatory operations and overall GRA processes such as regulatory intelligence, registration, certification documents, systems, and tools critical to regulatory affairs.
Scope:
This role reports directly to the Sr Regulatory Affairs Manager, Global Operations. The incumbent leads and carries out responsibilities with assistance and direction from their team leader. The incumbent provides support to international locations and interfaces with global regulatory associates.
Travel and overtime are expected on an occasional basis to meet workload demands.
Qualifications/Education/Experience Required:
Basic Qualifications:
Bachelor’s Degree in a relevant field (Sciences, Engineering, or equivalent degree) or another equivalent combination of education and experience.
- At least 3 years of prior relevant experience
- Detail-oriented and possess strong organizational skills to handle multiple projects.
- Ability to work effectively with computer systems and a thorough knowledge of current office practices and procedures.
- Ability to demonstrate judgement, function as a cooperative team member, organize workload, and set priorities.
- Strong organizational and time management skills.
- Ability to work well under pressure.
- Excellent oral and written communication skills.
- Fluency in English and ability to travel.
Preferred Qualifications:
- Experience supporting a Regulatory Affairs, Quality or Compliance team in a medical device, pharmaceutical, cosmetic, or similar company.
- A minimum of 2 years supporting the development and deployment of efficient and effective regulatory affairs processes, preferably across multiple geographic regions.
- Demonstrated proficiency in working within SAP database environments, document management systems, and Microsoft programs (Outlook, Excel, Word, PowerPoint, Visio, Project, etc.).
- Demonstrated understanding of Medical Devices and Cosmetic regulations across the globe.
- Basic understanding and experience interfacing with regulatory agencies.
- Demonstrate understanding and impact of industry regulation. Gather and articulate global requirements, as needed.
- Understanding of key regulations and standards applicable to K-C specifically related to medical devices or other highly regulated products.
- Experience working in quality systems where these regulations and guidelines are followed.
- Understands and can apply industry-standard practices such as Good Manufacturing (GMP)
- Basic/Intermediate technical writing skills and familiarity publishing documentation in document management systems.
- Ability to work effectively with external regulatory agency and trade association databases.
- Ability to anticipate and meet deadlines, handling multiple simultaneous deadlines, prioritizing work, strong attention to detail, organizational skills, and the ability to retain confidential information.
- Collaborative, responsive, and action-oriented with basic/intermediate problem-solving skills.
- Proven ability to effectively communicate in written and spoken English.
- Continuous improvement mindset.
- Project management skills.
- Ability to manage high volumes of work in a global, matrix environment.
To Be Considered
Click 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, check out the careers website. You’ll want to review this and come prepared with relevant questions if and when you pass GO and begin interviews.
And finally, the fine print…
For Kimberly-Clark to grow and prosper, we must be an inclusive organization that applies the diverse experiences and passions of its team members to brands that make life better for people all around the world. We actively seek to build a workforce that reflects the experiences of our consumers. When you bring your original thinking to Kimberly-Clark, you fuel the continued success of our enterprise. We are a committed equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, sexual orientation, gender identity, age, pregnancy, genetic information, citizenship status, or any other characteristic protected by law. The statements above are intended to describe the general nature and level of work performed by employees assigned to this classification. Statements are not intended to be construed as an exhaustive list of all duties, responsibilities and skills required for this position.
This role is available for local candidates already authorized to work in the role’s country only. Kimberly-Clark will not provide relocation support for this role.
Primary Location
Mumbai Corporate Office
Additional Locations
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Read Full Description