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Regulatory Affairs Coordinator

City: Ciudad de Mexico

We are Reckitt

Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.

Research & Development

In Research and Development, we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance.

We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.

The size of our organisation means you'll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.

About the role

The regulatory coordinator will provide specific knowledge and experience in the creation of dossiers for submission to regulatory authorities, will work to provide integrated support for regulatory planning through innovation and will provide the latest knowledge and information on regulatory requirements to complete a regulatory process.

The regulatory coordinator will ensure that all regulatory activities are executed and completed in accordance with best practices and regulatory compliance in a consistent manner in all projects. It will carry out a wide and close management with the areas of Marketing, Supply, Legal, Quality, Pharma Surveillance, GRA, R&D, etc.

The regulatory coordinator will have knowledge about the legislation of manufacturing and distribution sites of medicines and medical devices.

Your responsibilities

Performs the review of documentation, assembly and delivery of dossiers for the medicines under its responsibility, including variations, renewals or any other procedure that must be submitted to the Authority within the agreed times.
Guarantees high quality and precision in the dossiers vs agreed requirements and indicate on any potential issue that considers a risk for the purpose of the project working together with the areas that elaborate the documents.
Do advertising and import permits for products marketed in Mexico and products that will be conditioned to be exported.
It makes submissions through the digital platforms of COFEPRIS and VUCEM.
Performs reviews of the packaging artworks of the products of the Health Care area to ensure compliance with Official Mexican Standards and with the labels authorized by COFEPRIS.
Performs the monitoring of the applicable regulation for the products of its competence to detect updates and / or modifications to them and supports the Regulatory Manager filling the Regulatory Intelligence tool when knowing important changes to the regulation.
Supports all the work required to improve the regulatory processes and procedures that optimize the efficiency and precision of strategies for rapid access to the market: actively participates in brainstorming ideas for marketing claims and product name ideas.
It provides support to the Pharmacovigilance area.
Management and maintenance of the Regulatory Quality Management System (QMS). Creation, follow-up, and closure of CAPAs.

The experience we're looking for

- Bachelor in Pharmaceutical Chemistry (QFB, QFI, IF, LF or similar)
- Courses and trainings related to national and international regulation. Courses related to health surveillance.
- 3-5 years of experience in the field.
- English and Spanish fluent.
- Experience with Health regulation in Mexico (COFEPRIS) related to medicines is essencial, is also nice to have experience with medical devices, cosmetics, and dietary supplements, including: Sanitary Registrations, Amendments to Registration Conditions, Renewal of Sanitary Registrations, New Molecules Committee, Pharmacovigilance, Technovigilance, Cosmetovigilance, Advertising of Health Supplies in Mexico, Import Permits, Advertising Permits, Free Sale Certificates.

The skills for success

Problem Solving, Drive for Results, Creativity, Standing Alone, Managing Through Systems.

What we offer

With inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way. We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitt's potential future successes. For eligible roles, we also offer short-term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt's pay for performance philosophy.

Equality

We recognise that in real life, great people don't always 'tick all the boxes'. That's why we hire for potential as well as experience. Even if you don't meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you. All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.

Job Segment: Medical Device, Pharmacovigilance, Nutrition, Counseling, Healthcare