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Regulatory Affairs Executive

1-3 years
Not Disclosed
10 Oct. 8, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

🌟 We Are Hiring: Regulatory Affairs Executive 🌟

Location: Ahmedabad (On-Site)

Exciting Job Opportunity!

Are you passionate about ensuring compliance with local and international pharmaceutical regulations? Do you thrive in a creative and collaborative work environment? If so, Skycare Pharma is looking for you to join our team!

Job Responsibilities:

  • Develop and implement regulatory strategies to ensure compliance with local and international guidelines for pharmaceutical products.
  • Prepare and submit dossiers, including drug applications, variations, and renewals, in accordance with regulatory standards.
  • Stay updated on changes in regulatory requirements and communicate these changes to relevant stakeholders within the company.
  • Coordinate with cross-functional teams, including R&D, quality assurance, and marketing, to ensure regulatory compliance throughout the product lifecycle.
  • Develop and maintain relationships with key stakeholders.
  • Provide regulatory input for product development, including reviewing and approving labeling, packaging, and promotional materials.

Experience Required:

  • Minimum: 1-3 years of experience in regulatory affairs (preferred).

Qualifications:

  • Education: B.Pharm or M.Pharm.
  • Skills: Knowledge of CTD, ACTD, and ECTD filing. In-depth knowledge of dossier filing is essential.
  • Language: Proficiency in English (required).

Job Type:

  • Full-time, Permanent.

Salary:

  • Negotiable based on experience, knowledge, and skills.

If you're ready to contribute to a dynamic team, send your resume to: 📧 Email: info@skycarepharma.com📱 WhatsApp: +91 98750 11522

Join us and make a positive impact on the future of healthcare!