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2 weeks ago

Regulatory Affairs Specialist

TECHNO ENDURA
0 to 2 Yrs
Rs 4.0 - 6 Lakh/Yr
  • Regular
  • Job Details

Job Details

    Regulatory Affairs Specialist Job Description

    Responsibilities:

    • Prepare and submit regulatory documentation for new and existing medical products, including drugs, devices, and biologics.
    • Stay up-to-date on ever-evolving regulatory requirements and guidelines.
    • Liaise with regulatory agencies and respond to their inquiries.
    • Manage the regulatory approval process from pre-clinical development to post-market surveillance.
    • Develop and implement effective regulatory strategies to ensure timely market access for our products.
    • Analyze and interpret complex scientific and regulatory data.
    • Provide expert advice and guidance to internal teams on regulatory matters.
    • Manage and maintain regulatory databases and tracking systems.
    • Collaborate with cross-functional teams, including research and development, manufacturing, and marketing.

    Qualifications:

    • Bachelor's degree in science, healthcare administration, or a related field.
    • Minimum of 0- 2 years of experience in regulatory affairs, preferably in the pharmaceutical, biotechnology, or medical device industry.
    • Strong understanding of relevant regulatory guidelines (e.g., FDA, EMA, etc.).
    • Excellent written and verbal communication skills.
    • Ability to work independently and as part of a team.
    • Meticulous attention to detail and strong organizational skills.
    • Ability to prioritize and manage multiple tasks effectively.
    Interested to apply can share Cv or call/whatsapp to hidden_mobile  

Other Details

Recruiter Details

  • TECHNO ENDURA
  • Bangalore
  • hidden_email
  • hidden_mobile

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