Regulatory Affairs Specialist for Pharmaceutical Industry
4 weeks ago
**Company Overview**
SUCCESS VIBRANT is a leading provider of HR and PR solutions for businesses and organizations at various levels. Our dedicated team strives to meet the needs of our clients by offering efficient and reliable services.
**Job Overview**
We are seeking a highly skilled Regulatory Affairs Executive API PHARMA to ensure compliance with regulatory requirements for the manufacturing and distribution of pharmaceutical products. In this role, you will develop and implement regulatory strategies to ensure compliance with local and international regulations.
**Key Responsibilities**
- Review and analyze regulatory guidelines, legislation, and policies to ensure compliance.
- Prepare and submit regulatory documents, including registration dossiers, variations, and renewals.
- Coordinate and communicate with regulatory authorities for product registrations, approvals, and inspections.
- Ensure compliance with labeling and promotional requirements for pharmaceutical products.
- Monitor and track regulatory updates and changes that may impact the business.
- Collaborate with cross-functional teams to provide regulatory support and guidance.
- Participate in internal and external audits.
- Maintain regulatory documentation and records.
**Requirements**
- Bachelor's degree in Pharmacy, Chemistry, or a related field.
- Junior: 1 to 3 years of experience in regulatory affairs within the pharmaceutical industry.
- Knowledge of regulatory legislation, guidelines, and practices.
- Familiarity with regulatory submission processes and requirements.
- Strong attention to detail and ability to interpret complex regulatory documents.
- Excellent communication and interpersonal skills.
- Ability to work independently and collaboratively in a fast-paced environment.
- Experience with regulatory inspections and audits.
- Proficient in Microsoft Office Suite.
**Why Success Vibrant?**
At Success Vibrant, we offer a dynamic and supportive work environment, with opportunities for growth and development. If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity.
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