Halma plc is Hiring Regulatory Affairs Specialist

The role bears accountability and responsibility for international registration and regulatory operations. One essential member of the Quality and Regulatory team is the Regulatory Registration Associate. As a member of the internal and external audit team, the associate will be in charge of document control, registration maintenance, regulatory compliance through registrations, data analysis, and registration activity optimization. The associate will also support marketing, quality, and production with regard to regulatory matters including customers, processes, and quality.

Responsibilities :

1. Performs research, distribution, storage, tracking, and retrieval of relevant information/documents pertinent to the regulatory registrations and submissions.
2. Evaluates the local and international regulatory environment and assists in providing strategies throughout the product lifecycle to resolve potential regulatory issues and questions from regulatory agencies.
3. Authors, reviews, and publishes paper and electronic submissions and communicates with regulatory authorities and government agencies for new and sustaining product registrations or renewals.
4. Communicates with regulatory authorities and/or distributors to prepare and submit documentation for marketing approval in all markets.
5. Develop and evaluate risk of potential regulatory strategies for new and modified products by performing research and analysis in both new and sustaining markets.
6. Provides regulatory information and support for proposed product claims/labelling in local and international markets.
7. Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation.
8. Helps train stakeholders on current and new quality and regulatory requirements to ensure organization-wide compliance.
9. Partner closely with the Product Development and Product Management team to review proposed product changes for impact on regulatory status of the product.
10. Ensure documents and records meet quality standards and maintain onsite and offsite document storage.
11. Analyses data, tracks and trends quality metrics, and develops solutions as needed for management review.
12. Performs other duties that are reasonably assigned.

Requirements :

1. A Bachelor's degree is required, preferably in Science, Engineering, or Business.
2. Minimum 4-6 years of experience.
3. Minimum of 1-2 years regulatory registration/ submission experience is preferred.
4. Understanding of applicable FDA and ISO regulations with RAPS/RAC certification is preferred.
5. Experience in managing distributors, authorized representatives, and regulatory representatives of different regions is an advantage.
6. Excellent written and verbal communication and technical writing skills with strong attention to detail is required.
7. Proficient in Microsoft Office (Outlook, Excel, PowerPoint and Word).
8. Proficient in time management, multitasking, and organizational skills.
9. Proficient in project management and possess initiative and flexibility to see through completion f project objective.
10. Ability to interact with multiple departments, including Customer Service, Sales, Production, and Engineering.
11. Demonstrated success and track record as an individual contributor who has delivered on top line results.

Interested candidates can share their CVs to Suman.kumari@halma.com  |  sunitha.jayaprakash@halma.com