SR. ASSOCIATE, REGISTRATION & REGULATORY COMPLIANCE (TEMPORAL) - XPR
Descripción de la oferta de empleo
Associate is the owner of the product dossiers.
Under this ownership, the Sr Associate maintains valid records; prepares and presents the renewal processes of the current registrations; analyzes and prepares the documentation for registration/notification of new products, renewals, or changes in registered/notified products; understands and applies the label requirements, company policies, and procedures related to the introduction of new products, changes, and labeling; responds to requests from project teams to provide critical information about regulatory needs for product launches; keeps the company up to date with current legislation impacting the business; coordinates, carries out, and follows up on sanitary product registration plans until their completion; participates in multidisciplinary product launch projects, provides input, requests documents, and provides regulatory information necessary to specify the registration actions and meet the dates for regulatory activities.
This position reports to the Manager, Registration and Regulatory Compliance Latin America Southern Cluster, and belongs to the GSARA (Global Safety Assessment and Regulatory Affairs) organization.
KEY RESPONSIBILITIES Compile dossiers and submit registrations for new products, modifications, and renewals.
Design, develop, and implement appropriate registration strategies.
Provide input at an early stage of the process regarding registration strategy.
Develop and approve artwork (AW), providing the specific information required per country.
Complete all internal systems in a timely manner to keep registration information updated.
Support and attend audits, ensuring and proving registration and compliance information.
When appropriate, engage and build strong relationships in Regulatory Affairs Committees at key trade associations and with health authorities.
Serve as a company regulatory representative in key technical and regulatory external forums.
REQUIRED EXPERIENCE YOU'LL BRING +1 year related experience in regulatory affairs roles, dossier compilation and registration submission, innovation support.
Bachelor of Science degree, in a related science (Pharmacy, chemistry, biology, engineering, etc.).
Teamwork, Exceptional communication and interpersonal skills.
PREFERRED EXPERIENCES AND SKILLS Ability to speak/understand/write English Orientation to detail Inclusion & Diversity We're a global business, with people from every culture, ethnicity, race, religion, gender identity, sexual orientation, age and ability.
We recognize the breadth of human experience, and we work to celebrate it.
It is our goal to build a diverse, inclusive and supportive work environment where all people can thrive.
We're committed to ongoing efforts that help us attract, hire, and retain diverse talent who want to build a positive, inclusive environment.
Read more about our ongoing initiatives at https://jobs.
cjohnson.
om/inclusion.
Detalles de la oferta
- Sin especificar
- En todo México
- Sin especificar - Sin especificar
- 26/08/2024
- 24/11/2024
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