Regulatory Affairs Specialist

22 hours ago

Ahmedabad, Gujarat, India beBeeRegulatory Full time ₹ 9,00,000 - ₹ 12,00,000

Regulatory Affairs Professional

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  • Job Description:
  • As a key member of the regulatory team, you will be responsible for ensuring the timely submission of high-quality regulatory documents and providing strategic guidance to team members.
  • You will interact with various stakeholders across functions including Compliance, Marketing, R&D, Engineering, Manufacturing, and QA/QC.
  • Additionally, you will participate in discussions to provide regulatory guidance to team members in India and other regions.
  • Your responsibilities will also include interacting with regulatory agencies on regulatory submissions and follow-ups of drug products.
  • You will oversee the preparation and filing of high-quality submissions to regulatory authorities.
  • Your goal will be to ensure that all applications are filed in accordance with regulations and requirements.
  • You will provide regulatory guidance to staff and inter-disciplinary project teams.
  • You will be a proactive member of the Regulatory team to ensure Baxter's continuing compliance with regulatory authorities.
  • Furthermore, you will continue to develop quality standards and procedures for RA.
  • You will facilitate product development/Launch activities for respective Markets.
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Required Skills and Qualifications:

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  • Education: Bachelor's degree in a related field such as life sciences, chemistry, or biology.
  • Experience: At least 5 years of experience in regulatory affairs, preferably in a pharmaceutical company.
  • Skills: Excellent communication and problem-solving skills, ability to work in a team environment, and proficiency in MS Office.
  • Qualifications: Strong knowledge of regulatory guidelines and requirements, excellent attention to detail, and ability to meet deadlines.
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Benefits:

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  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • Collaborative and dynamic work environment.
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Others:

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  • We offer a comprehensive compensation package that includes a competitive salary, bonus, and stock options.
  • Our employees enjoy a collaborative and dynamic work environment that fosters innovation and creativity.
  • We are committed to developing our employees through training and development programs.

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