Regulatory Affairs Executive

1-3 years

Not Disclosed

Ahmedabad

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!

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Regulatory Affairs Executive

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