Regulatory Affairs Specialist
Regulatory Affairs Specialist
Posted on :
20-01-2025
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1 Vacancy
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Job Description
Job Title: Regulatory Affairs Specialist
Job Location: Hyderabad Telangana India
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
Responsible for the daytoday activities and delivery of Global Regulatory Affairs support services. Role will include management of clinical trial applications to Competent Authorities Ethics Committees and Regulatory Agencies and the research review and reporting on applicable global regulations and requirements. Develop stakeholder tools process/document regulatory risk assessments and provide support expertise and represent the unit with other functional units sponsors researchers and/or regulatory authorities. Ensure high quality timely service delivery processes are maintained in accordance with corporate industry and regulatory standards and guidelines. May be required to coach peers and/or provide input for staff performance reviews.
Unit Management
Unit Management
- Coordinate the day to day delivery of regulatory services and processes including compilation of regulatory filings/submissions/revisions for projects third party vendors and clinical sites.
- Conduct or assist with regulatory and/or safety reviews create regulatoryrelated tools educational/training materials and remain current on all aspects of clinical research regulatory requirements and industry best practices communicating changes to project leaders in a timely manner.
- As the corporate subject specialist in regulatory affairs provide regulatory ethics and/or pharmacovigilance guidance and support to project stakeholders.
- Represent the unit at project meetings assisting with project education/regulatory tool development at regulatory reviews and audits with clients ensuring expectations are managed and met with regulatory ethics and government representatives and when appropriate respond to regulatory queries on behalf of the client.
- Identify changes in clinical research regulatory requirements and industry best practices and recommend implement and maintain corporate regulatory strategies working with other experts (safety quality assurance) when appropriate to meet or exceed compliance requirements of evolving regulatory initiatives.
- Participate in specialized conferences/meetings to increase knowledge as needed.
- Regularly respond to registration requests and work with project teams to identify regulatory requirements.
- Assist in the preparation of regulatory submissions and support summaries.
- Ensure project/clinical site files and documents are developed maintained revised archived and/or destroyed in accordance with project and regulatory requirements and that all project stakeholders are fully informed and trained on all applicable regulatory requirements.
- Applicants should have a minimum of an undergraduate degree and 46 years of relevant experience in Clinical Research/Regulatory Affairs.
- The successful candidate will possess strong knowledge of EMA regulations.
- Homebased
- *Accommodations for job applicants with disabilities are available upon request.
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Employment Type
Full Time
Key Skills
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