Regulatory Support
Regulatory Support
Posted on :
16-10-2024
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
- experience in pharmaceutical environment.
- Experience in regulatory environment is required.
- High level exposure or knowledge about FDA inspection and internal audit process.
- Knowledge or exposure on Veeva RIM Submission/Archive Publishing etc.
Job Title: Consultant
Qualifications:
- Bachelors degree preferably in a life science or a related field
- 5 to 10 years of experience in pharmaceutical environment.
- Experience in regulatory environment is required.
- Excellent written verbal communication and presentation skills.
- High level exposure or knowledge about FDA inspection and internal audit process.
- Knowledge or exposure on Veeva RIM Submission/Archive Publishing etc.
JD details :
- Ensure compliance with company Standard Operating Procedures and regulatory agency regulations/guidance.
- Represents Regulatory Affairs on crossfunctional project teams.
- Provide technical expertise to crossfunctional teams on managing the lifecycle of submissionrelated documents.
- Work with Veeva Submissions/Archive team subject matter experts and cross functional departments to support business needs.
- Effectively communicate and work collaboratively with crossfunctional teams including regulatory affairs clinical operations and quality assurance & validation.
- Gather and assemble information necessary for submissions in accordance with regulations/guidance.
- Capable of reviewing documentation with a high degree of attention to detail. Proactive to identify issues and propose solutions as necessary.
- Conduct review of published submissions to ensure consistency and compliance with regulatory requirements.
- Maintain knowledge of local and global regulatory submission requirements.
- Maintain compliance with GxP government regulations industry standards approved specifications and Company procedures &directives.
- Provide Regulatory Affairs support during internal and external audits and inspections.
- Exposure in Change management process requirement gathering qualifying the changes etc.
- Actively participate in the development of Regulatory Operations processes like SOPs/GOPs Work instructions Checklist templates etc.
- Consistently support for regulatory systems access and change management.
- Responsible for communicating business process improvements business related issues status updates or opportunities.
Veeva,pharmaceutical
Employment Type
Full Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
