Regulatory affairs manager

A collective energy and ambition. A place where you can make a real difference.

We’re a company that genuinely cares about our people, our products, our consumers and the environment.

Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared passion to work hard, innovate and push boundaries.

United by the belief that when we strive for growth, anything is possible. While we might not be the largest company in our industry, we believe we can have the biggest impact because: Together We Have the Power to Win.

This role will provide regulatory expertise and direction in support of brands to be supplied through Distributors in Asia Pacific region (excluding Australia, China and Japan). This role will also lead regulatory strategy and activities in emerging markets as they move across to direct model without regulatory staff in market (e.g. South Korea and pipeline). This role will manage registration activity, the acquisition of local resources where required, including developing Regulatory strategy on complex technical projects.

Strategy includes liaising between company and domestic regulatory authorities, providing feedback on potential new products, supporting acquisition actions including assisting management in due diligence review. Analyse emerging Regulations. Provide technical mentorship to team members. Serve as a lead technical interface for the department.

Role Accountabilities and Responsibilities

• Develop regulatory strategy on complex registrations.
• Collect and analyze data in support of submissions and due diligence review in support of acquisition activities. Report results, draw conclusions, and make data-based recommendations to management or brand/R&D teams.
• Act as liaison between Regulatory Affairs and other departments within the Company in support of the launch of brands.
• Act as liaison with government agencies and trade associations on assigned projects in support of brands.
• Execute the assembly of common technical documents and products information packages that support the registration of products in China and the Asia Pacific Region.
• Ensure that registration renewals will be achieved on time to avoid lost sales.
• Be proactive to be aware about new regulations that could impact business.
• Develop network of local market experts to advice regulatory execution for new products categories or markets.

Qualifications and Skills

Education:

• Bachelor’s degree, preference to a degree in a relevant subject such as Quality & Regulatory Affairs.

Experience:

• Seasoned regulatory professional with 8+ years’ experience in a regulatory affairs function with demonstrated strategic capability and significant Asia Pacific experience.
• APAC experience across several or all categories including cosmetics, medical device, OTC, Quasi Drugs and household chemicals is a requirement.
• Proven ability to resolve complex regulatory issues and work across a highly dynamic portfolio.
• Proven team manager and talent developer.
• Additional international RA experience and advantage - additional QA experience an advantage.
• Track record of business and customer orientation.

Skills & Competencies:

• Strong results orientation.
• Ability to manage multiple projects and work cross-functionally.
• Excellent communication skills, multi-lingual an advantage.
• Strong organizational skills.

Church & Dwight is proud to be an Equal Opportunity Employer/Veterans/Individuals with Disabilities.

For more information on our company, our brands and our culture visit us at http://www.churchdwight.com/