Regulatory Affairs Specialist
Regulatory Affairs Specialist
Posted on :
23-07-2025
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1 Vacancy
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Job Description
Summary:
Provides regulatory support to all preapproval and post approval activities for new products and existing products through products lifecycle. Prepares and compiles drug product regulatory documents. Provides regulatory guidance to matters related to product development.Primary Functions:
1. Coordinates activities in the preparation of Regulatory Drug Product Applications (i.e. ANDA NDAs Marketing Authorizations Amendments Annual Reports Supplements CMC Sections etc.):
- Searches retrieves and compiles all the necessary documentation for authoring of the applicable regulatory filing.
- Ensures technical accuracy and regulatory completeness of documentation to support drug product regulatory submissions.
- Provides regulatory guidance to the chemistry manufacturing and control sections of INDNOA ANDA; and supplemental filings in line with previous development work.
- Reviewing technical information and reports in support of new products for accuracy a regulatory acceptability.
- Advising clinical supply manufacturing and packaging activities.
- Coordinate shipping of clinical samples for bioequivalence studies.
- Monitoring the conduct and progress of clinical investigations.
- Review and approval of technical documents such as specifications protocols and reports.
- Searches retrieves and compiles all the necessary documentation for authoring of the applicable post approval filling.
- Advises on CMC activities in support of post approval changes for new and existing products.
- Evaluates change requests for regulatory acceptability to maintain drug approva1 conditions.
- Coordinates and performs Drug Product Listing activities for new and revised products.
Secondary Functions:
- Performs labeling activities; reviews and approves promotional material.
- Develops and maintains the departments Standard Operating Procedures and related documents as the apply to Regulatory Affairs mission.
- Evaluates new tendencies and changes in regulations related to pharmaceutical products and give support to the operational areas.
- Receives reads interprets and determines applicability of FDA or International regulations to development of products submissions and post-marketing reports.
- Support regulatory audits requirements.
- Evaluate applicable laws and regulations to determine impact on organizational activities.
- Acts as an advisor on regulatory matters and explain regulations policies or procedures.
- Performs other duties as assigned.
- Bachelors Degree preferably in Science: Pharmacy Chemistry or Biology. Equivalent experience related to regulatory affairs or in the pharmaceutical industry may substitute for academic background in science.
- Minimum of three to five years of broad-based Quality Operations pharmaceutical manufacturing and/ or related regulatory experience
Experience Requirement:
- Experience with regulatory impact assessment of changes and registration requirements on global markets compiling information and preparing regulatory filing documents.
- Experience with the preparation and review of dossier for regulatory filing is highly desirable.
- Knowledge of regulatory filing requirements for US EU and ROW. Knowledge of applicable State Federal and International Regulatory requirements (DSPR OSHA EPA FDA ASSMCA MHRA ANVISA MOH etc.).
- Knowledge in Quality Control Systems.
- Excellent communication skills in English and Spanish.
- Computer knowledge in Words Excel and Power Point programs.
- Document management and project management desirable
- Travel may be required.
Work Methodology:
- 100% On-site
- Administrative Shift full time
- Temporary Contract
- 3-6 months of project assignment
Required Experience:
Unclear Seniority
Employment Type
Full Time
Key Skills
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