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Regulatory Affairs Associate

Princeton, NJ 093657

Posted: 03/24/2023 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 547636 Is job remote?: No Country: United States

Job Description


Target PAY: 55-59/hr
SUMMARY:
Regulatory Affairs Operations Associate to support submission review, publishing in eCTD format and archiving for ANDAs, NDAs, sNDAs, INDs, DMFs, annual reports and safety reports. Technical document preparation for electronic submission such as bookmark, hyperlink and PDF properties. Ensuring the compliance and deliverables of applicable regulations, guidance requirements, such as documents formats and named in accordance with FDA, ICH guidelines & internal guidelines/SOPs. Engage in life cycle management of submission documents (if necessary) to ensure document integrity in DMS and publishing tool. Track and monitor metrics, maintains submission tracking tool and trackers daily. Utilize Electronic Submission Gateway (ESG) to submit submissions to FDA centers. Utilizing technical skills for learning new features/applications of software which can support to improve the efficiency and complexity. Demonstrates robust communication and listening skills; must be able to effectively identify opportunities and challenges and partner with co-workers in identifying solutions. Other functional duties as requested by management.

Education: Bachelors degree

Experience: 3-5 years of related professional experience in the pharmaceutical industry with 2 of those years in regulatory affairs registration and publishing management.
  • Computer knowledge, problem solving skills, working knowledge of regulatory and drug development processes, technical knowledge, innovative and creative and possesses good judgment.
  • Good understand of CTD and US FDA registration requirement.
  • Adherence to all health, safety & environmental requirements in support of departmental and site HSE goals. Work in a safe and efficient manner.

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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