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Regulatory Affairs Specialist II (Remote or Hybrid)

Tucson, AZ 85755

Posted: 11/02/2023 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 589533 Is job remote?: No Country: United States

Job Description


Responsibilities
• Works under moderate guidance and is responsible for the coordination and preparation of document packages
for regulatory submissions from all areas of the Company. Compiles materials required in submissions, license
renewals and annual registrations.
• Keeps abreast of regulatory procedures and changes.
• Coordinates the collection of documents, records, reports, and data from the Development, Clinical Affairs, Quality, and Operations Departments for inclusion in regulatory documents.
• Assists in the preparation of international registration dossiers for use in international registration.
• Participates with internal/external teams and builds professional relationships.
• Identifies and suggests solutions to Regulatory tasks.

• Other duties as assigned by management.

QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the responsibilities.

Formal Training/Education
Education Level Education Details Req Pref
Bachelor's Degree or equivalent X

Experience
Years of Experience Experience Details Req Pref
5 years of related Regulatory Affairs experience.

Are equivalencies acceptable?
No

Knowledge, Skills and Abilities
Knowledge, Skill or Ability Req Pref Proficiency

Licenses and Certifications
Licenses/Certifications Licenses/Certifications Details Attainable Within XX Months Req Pref

Travel Requirements
Estimated Amt Brief Description
5% Based on business needs

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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