Regulatory Affairs Coordinator

At Bayer, our aspiration is to become a more flexible and agile company. We seek out ways to Improve Health and Nutrition – our Teams are key players to enable Innovation.

 Consumer Health’s headquarters is in Basel, Switzerland, with over 10,000 people in more than 100 countries. Our division comprises 12 manufacturing sites and 4 research and development centers. Our brands hold leading positions in key categories including Allergy + Cough & Cold, Dermatology, Digestive Health, Nutritionals, and Pain + Cardio.

Today, Consumer Health produces some of the world’s leading OTC brands, many of which are household names – including Claritin, Afrin, Bepanthen, Canesten, Alka-Seltzer, Rennie, Iberogast, Elevit, Berocca, Redoxon, Supradyn, Aspirin and Aleve.

Consumer Health’s purpose is to Empower the Transformation of Everyday Health for millions of people around the world. Through our broad portfolio of leading and trusted brands, consumers can take charge of their health - to get well, be well, and stay well.

 ARE YOU a passionate and committed Team Player?

CAN YOU thrive with Ambiguity?

DO YOU collaborate well across diverse teams and contribute to a more inclusive environment?

CAN YOU build strong relationships with stakeholders?

DO YOU possess lean, agile ways of thinking and a strong digital mindset?

If you answered YES, this Opportunity is for YOU!

Our ultimate goal: Health for all Hunger for none.

Your Tasks and Responsibilities

-Supports IRA Latam Sr Manager and Local RA Heads in Due Diligences.

-Define Regulatory strategy for dossier preparation and submission with Local Regulatory colleagues.

-Review legal, technical, clinical and non-clinical requirements for the projects under her/his responsibility.

-Define Regulatory timeline for the projects under her/his responsibility.

-Provides Regulatory advice to stakeholders in regard to different requirements for different product categories: Medicinal OTC, Food Supplement, Herbal, Cosmetic, Medical Device.

-Review all the documents that integrates the dossiers to ensure compliance with local regulations.

-Ensures timely dispatch of the dossiers under her/his responsibility.

-Supervise and agrees with global legal counsel on the content of legal documents (GMPs, Free Sale Certificates, TWIMC letters etc) needed for the registration of the regional products in the different countries.

-Gather scientific support (bibliographic references, clinical studies, non-clinical information, monographs, etc), to integrate them into the dossiers.

-Perform the activities in Regulatory Systems to prepare and dispatch dossiers for her/his projects.

-Makes follow up with countries until the approval of the marketing authorizations.

-Elaborates robust plans for her/his projects (New Drug Applications)

-Ensures that all the information of her/his dossiers is properly and timely recorded in systems(Synaps, DORIS).

-Support Regulatory Affairs Sr Manager in regional initiatives intended to improve efficiencies not only at regional level but at local level.

-Support Regulatory Affairs Sr Manager in the follow up of regional plans and metrics.

-Support to IRA Sr. Manager in the preparation of specific reports for Regional Director or other global functions (PS, Quality, etc).

Who you are

-Life Sciences degree (Pharmacist), Chemical Pharmacist Biologist or other Life Sciences degree

-Proficiency in MS Office: Word, Excel, PowerPoint, Visio

-High proficiency in English language; advanced ability to communicate effectively verbally and in writing

-5 years of experience in Pharmaceutical Industry, in Regulatory Affairs area; experience working with Herbal and Food Supplement products is a must.

- In a similar position (at least 1 year)

Temporal position with contract ending on December 31st, 2023