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Regulatory Affairs Associate - CMC

Naukri Healthcare Jobs
Posted on
Naukri Healthcare Jobs logo

Experience
1 - 3 yrs
Job Location
Bengaluru, India
Vacancy
1
Designation
Regulatory Affairs Associate
Job Type
Not specified

Job Description

We are looking for a highly skilled and experienced Regulatory Affairs Associate to join our team at Ruputed Pharmaceutical Company in the Pharmaceutical & Life Sciences industry. The ideal candidate will have a strong background in regulatory affairs, particularly in CMC.
Roles and Responsibility
  • Develop and implement regulatory strategies for new products and submissions.
  • Prepare and review regulatory documents, including clinical trial applications and marketing authorizations.
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
  • Conduct thorough reviews of regulatory documents to identify potential risks and opportunities.
  • Provide guidance on regulatory matters to internal stakeholders and external partners.
  • Stay up-to-date with changing regulatory requirements and industry trends.
Job Requirements
  • Bachelor's degree in Pharmacy or a related field.
  • Proven experience in regulatory affairs, preferably in CMC.
  • Strong knowledge of pharmaceutical regulations and guidelines.
  • Excellent communication and project management skills.
  • Ability to work effectively in a fast-paced environment and meet deadlines.
  • Strong analytical and problem-solving skills.