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Seven Consultancy
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Regulatory Affairs Specialist

Regulatory Affairs Specialist

Seven Consultancy

10 - 15 years

6 - 10 Lacs

bengaluru

Posted:17 hours ago| Platform:

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Skills Required

pharma regulatory affairs

Work Mode

Work from Office

Job Type

Full Time

Job Description

We are looking for a highly skilled and experienced Regulatory Affairs Specialist to join our team in Bangalore, Bengaluru, Karnataka, India. The ideal candidate will have 10 years of experience in the pharma or medical device industry.

Roles and Responsibility

Develop and implement regulatory strategies to ensure compliance with relevant laws and regulations.
Prepare and review regulatory documents such as clinical trial applications, marketing authorizations, and periodic safety update reports.
Collaborate with cross-functional teams including research and development, quality assurance, and manufacturing to ensure alignment with regulatory requirements.
Conduct thorough reviews of regulatory submissions to identify areas for improvement and provide recommendations for enhancement.
Stay up-to-date with changing regulatory requirements and develop plans to address these changes.
Provide training and guidance to internal stakeholders on regulatory affairs matters.

Job Requirements

Strong knowledge of regulatory requirements governing the pharma or medical device industry.
Excellent analytical and problem-solving skills with attention to detail.
Ability to work collaboratively in a team environment and communicate effectively with internal stakeholders.
Strong project management skills with the ability to prioritize tasks and meet deadlines.
Experience with regulatory software and systems is an asset.
Strong understanding of Good Clinical Practice (GCP) principles and regulations such as GxP.
Educational qualification: Any Graduate/Postgraduate degree.

Additional Info

For more information, please contact Harshala at 9029063330.

Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.

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Regulatory Affairs Specialist