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Lilly Senior Associate Regulatory Affairs in Utrecht, Netherlands

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

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Senior Associate Regulatory Affairs - Netherlands

Purpose:

The purpose of the Senior Associate Regulatory Affairs role is:

  • To coordinate regulatory submissions for approval of NCE’s, line extensions, new indications, new patient populations etc.

  • To maintain current registrations.

  • To advise on/adhere to all matters relating to local drug law/regulations and company policies.

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

1) Submission of dossiers for medicinal products to be registered via national procedure, mutual recognition procedure or central procedure.

For European or mutual recognition registered products:

  • Making translations for product literature (SmPC, Label, PIL)

  • Submit the actual dossier to the local authorities

  • Manage general questions from the local authorities regarding the submitted dossier.

2) Maintenance of licences of medicinal products registered via mutual recognition procedure or central procedure (e.g. submission of variations and labeling changes).

For European or mutual recognition registered products:

  • Making translations for product literature (SmPC, Label, PIL)

  • Submit the actual variation/labeling changes to the local authorities

  • Manage general questions from the local authorities regarding the submitted variation/labeling changes.

  • Distribution of all new approved SPCs to internal (marketing and sales) and selected external parties.

3) Coordinate the update of packaging items for registered products to be in compliance with labeling and packaging guidelines.

Initiate, verify and approve changes to packaging items.

Submitting new packaging material to local authorities and coordinating the communication until approval and actual implementation of the new packaging items.

Initiating the request KNMP numbers at Z-index.

4) Share regulatory knowledge with relevant Lilly colleagues.

Share knowledge on regulatory timelines and strategy for specific products.

Share general regulatory knowledge with Lilly colleagues.

5) Provide support concerning regulations and labeling of clinical trial material.

Advise on labelling of CT material.

Provide regulatory approval of labeling.

Minimum Qualification Requirements:

  • Education: Bachelors/University Degree in Health care-related of life science field or equivalent demonstrated experience is required

  • Excellent communication skills

  • Team player

  • Comprehensive knowledge and understanding of local and Global and EU regulatory legislation

Other Information/Additional Preferences:

  • Dutch language skills-written and verbal

  • English language skills- written and verbal

  • Living in the Netherlands

The Senior Associate Regulatory Affairs will report to the Manager-QPV & Medical Affairs Services.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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