Skycare Pharma, a leading player in the pharmaceutical industry, is hiring a Regulatory Affairs Executive for its on-site office in Ahmedabad. If you have a background in regulatory affairs and are ready to take on an exciting new role, this could be the perfect opportunity to join a dynamic team dedicated to healthcare and compliance.
Job Title:
Regulatory Affairs Executive
Location:
Ahmedabad, Gujarat
Key Responsibilities:
As a Regulatory Affairs Executive at Skycare Pharma, you will be responsible for ensuring that the company’s pharmaceutical products comply with local and international regulatory requirements. The key responsibilities include:
- Knowledge of Regulatory Filing: A thorough understanding of CTD, ACTD, and ECTD filing is required, along with in-depth knowledge of dossier filing.
- Regulatory Strategy Development: Create and implement regulatory strategies to ensure compliance with national and international regulations.
- Dossier Preparation: Prepare and submit dossiers, including drug applications, variations, and renewals.
- Regulatory Updates: Stay updated on regulatory changes and communicate these updates within the company to maintain compliance.
- Cross-Functional Coordination: Collaborate with teams such as R&D, quality assurance, and marketing to ensure compliance across all stages of the product lifecycle.
- Stakeholder Relationships: Build and maintain strong relationships with key stakeholders to facilitate compliance and smooth regulatory processes.
- Regulatory Input: Provide input on product development, including reviewing and approving labeling, packaging, and promotional materials for regulatory compliance.
Qualifications:
- Education: B.Pharm or M.Pharm is required.
- Experience: 1-3 years of experience in regulatory affairs is preferred.
- Skills: Strong understanding of regulatory requirements, with excellent communication skills in English.
Preferred Skills and Experience:
- Experience in handling CTD, ACTD, ECTD filing and dossier preparation.
- Knowledge of local and international pharmaceutical regulations.
- Proficiency in communicating regulatory updates and working with cross-functional teams.
- Ability to handle multiple projects and ensure timely submission of required documents.
Salary:
- Negotiable: Based on experience, knowledge, and skills.
Job Type:
- Full-Time: Permanent position.
How to Apply:
If you meet the above qualifications and are ready to take your career in regulatory affairs to the next level, WhatsApp your resume to +91 98750 11522 or send your resume via email to info@skycarepharma.com.
For more details, visit the official website: skycarepharma.com.
