Job Description The Position The Regulatory Affairs Intern provides support in medium and low complexity processes, using the company's tools, software and systems. The above is in compliance with the provisions of official procedures. Hybrid model - 2x / week

Responsabilities

- Support in the preparation, submission and monitoring of the necessary documentation for the different regulatory procedures such as: Registration, Re-registration, Technical updates, Modifications to the health registry, corrections as applicable.
- Daily review the status/approvals of the procedures in the external computer programs of the regulatory agencies and check that the different databases and check lists are up to date.
- Provide support to keep the Good Manufacturing Practices certificates of all the corresponding plants for the products in charge up to date.
- Keep the electronic and physical file updated in accordance with the established procedure.
- Provide support in the entry of deficiency letters received from the health authority.
- Establish good working relationships with both internal and external personnel (regulatory agency) maintaining a professional image on behalf of the company.
- Support artworks production and review through the company's internal system.
- Protect company information, ensuring that it is not disclosed except when necessary (Legal representative, health agency) and when it is duly covered with the appropriate confidentiality agreements.
- Carry out the required training within the established times.
- Request for translation support for regulatory processes.




- Update the technical sheets and inserts on the designated internal platforms.

Required Education, Experience and Skills

Required Education: Pharmaceutical Chemist

Experience: Minimum 6 months of experience in areas of regulatory affairs.

Basic knowledge of current regulations for pharmaceutical products and medical devices

Knowledge in document management

Interest in areas of administrative support

Intermediate level English

Intermediate and/or advanced office management

Skills: Teamwork Flexibility and adaptation to change Effective communication Analytical thinking Commitment

Secondary Job Description

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.



As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.

Annualized Salary Range

Annualized Salary Range (General) Annualized Salary Range (Canada) Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status: Intern/Co-op (Fixed Term) Relocation: No relocation VISA Sponsorship: Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites Flexible Work Arrangements: Shift: Valid Driving License: Hazardous Material(s): Number of Openings: 1

At Organon, we aspire to improve the lives of people globally by unleashing the promise of trusted brands across women’s health and other important therapeutic areas. We are committed to becoming the world’s leading women’s health company investing in innovations that support women’s wellbeing. Fueled by its leading contraceptives and fertility businesses, Organon will invest in innovations that support the distinct health care needs of women today. Organon will also focus on its important biosimilars business, focusing on oncology and inflammatory diseases, while also maximizing the value of its trusted dermatology, pain, respiratory and cardiovascular portfolio in countries around the world where there is still great need for these treatments.

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📌 Regulatory Affairs Intern - PERU (Lima)
🏢 Organon
📍 Lima