Manufacturing-Jobs in United States

No visa or accommodation sponsorship

You will be responsible for regulatory activities required at a country level for pharmaceutical products including maintenance and approvals, marketing authorization transfers, communication with the Health Authority, artwork approval, etc., ensuring regulatory compliance in the applicable market(s).

As part of the IQVIA Global Regulatory Affairs department, you will be working with our clients, global pharmaceutical companies.

JOB OVERVIEW

Essential Functions

1. Manage the local regulatory submission preparation in collaboration with internal and external stakeholders based on the agreed strategy for designated countries.
2. Submit submissions such as renewals, variations, new applications, filings, MAH transfers to the local Health Authority and EMA, and follow up on the local regulatory approval process for designated countries.
3. Preparation of local Product Labelling (e.g., SmPC, PIL) in local language for designated countries.
4. Artwork review and approval in client systems.
5. Manage multiple pharmaceutical products.
6. Act as subject matter expert in regulatory processes.
7. Acts as a Regulatory Team Leader on more complex projects which may include authoring of regulatory documentation and filling application forms.
8. Establishes relationships with customers; may meet face to face to discuss regulatory issues, present lessons learned, and discuss customer comments.
9. Acts as a Subject Matter Expert in Regulatory knowledge in Chemistry Manufacturing and Controls or Lifecycle Maintenance / Marketing Authorization Transfers/ Labeling/ Publishing.
10. Project budget management.
11. Give guidance to junior colleagues including feedback on the quality of technical documents and may assist in their training and development.
12. Possible exposure to present to clients on complex regulatory processes and bid defense meetings.
13. Act as reviewer for regulatory standard operating procedures.
14. Prepare and deliver internal regulatory training if required.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

Experience: Typically requires 8-10 years of prior relevant experience.

Education: Masters Degree in Life Sciences or related discipline.

Skills and Abilities:

• Good understanding of the Research and Development process (Chemistry Manufacturing & Controls) relevant regulatory guidelines.
• Possesses specific regulatory or technical expertise.
• Interpersonal communication (oral and written) and organization skills.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Demonstrates self-motivation and enthusiasm.
• Ability to adapt quickly to a rapidly changing environment.
• Knowledge of Maintenance of Marketing Authorization.
• Experience of preparing variation renewal packages and artwork approvals.
• Fluent in English and able to effectively communicate complex business language to those who speak English as a second language.
• Must be fluent in Arabic.

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