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Regulatory Affairs Specialist

0.00 to 2.00 Years   Mumbai City   10 Apr, 2024
TECHNO ENDURA
Job LocationMumbai City
EducationNot Mentioned
SalaryRs 4.0 - 6 Lakh/Yr
IndustryMedical / Healthcare
Functional AreaPharmacist / Medical Representative
EmploymentTypeFull-time

Job Description

    Regulatory Affairs Specialist Job DescriptionResponsibilities:
    • 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:
    • Bachelors 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

Keyskills :
regulatory guidelinesregulatory affairshealthcare complianceregulatory matters

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