Regulatory Affairs Intern - PERU

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

• Preferred 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. 

Search Firm Representatives Please Read Carefully 
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Annualized Salary Range

Annualized Salary Range (Global)

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