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Regulatory Affairs Specialist II (Remote or Hybrid)
1910 E Innovation Park Dr Tucson, AZ 85755 US
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
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The 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, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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