Position: Regulatory Affairs
Organization: Archerchem Healthcare Pvt Ltd
Location: Mumbai, India
Qualification: B.Pharm or M.Pharm
Experience: Freshers or experienced professionals
Salary: Not Disclosed
Application Deadline: Open until filled
About Archerchem Healthcare Pvt Ltd
Archerchem Healthcare Pvt Ltd is a leading pharmaceutical company in India specializing in the development, manufacturing, and global distribution of high-quality healthcare products. The company operates in various international markets, including South East Asia, Africa, the Middle East, LATAM, and CIS countries.
The Regulatory Affairs team plays a pivotal role in ensuring that all products adhere to international standards, helping Archerchem expand its presence in global markets.
Job Description
Archerchem Healthcare Pvt Ltd is hiring freshers for its Regulatory Affairs department. This role is based in Mumbai and is open to B.Pharm or M.Pharm graduates. The position is ideal for those with a keen interest in regulatory guidelines, dossier preparation, and compliance management.
Key Responsibilities
The role involves supporting Archerchem’s regulatory functions to ensure compliance with global standards. Specific duties include:
- Preparation, Compilation & Review of Dossiers: Handle CTD, ACTD, and eCTD dossiers in compliance with regulatory standards for submissions across various global markets.
- Regulatory Guidelines Knowledge: Stay updated on regulations across South East Asia, Africa, the Middle East, LATAM, and CIS countries.
- Loan License & P2P Knowledge: Manage cross-border regulatory activities with an understanding of loan licenses and P2P regulatory operations.
- Artwork Preparation & Checking: Ensure that product packaging aligns with the regulatory requirements of target markets.
- Inter-Department Coordination: Collaborate with other departments to streamline the regulatory process, ensuring production meets compliance standards.
Required Qualifications
| Qualification | Experience Level | Location |
|---|---|---|
| B.Pharm or M.Pharm | Freshers/Experienced | Mumbai |
Eligibility Criteria
- Fresh graduates in B.Pharm or M.Pharm with strong academic performance.
- Experienced candidates in regulatory affairs are also encouraged to apply.
- Good knowledge of regulatory frameworks in global markets, especially in pharmaceutical compliance.
- Familiarity with loan licensing and P2P operations.
- Strong attention to detail and communication skills for inter-departmental coordination.
About Regulatory Affairs
The field of Regulatory Affairs in the pharmaceutical industry ensures that pharmaceutical products meet all the necessary regulatory compliance and safety standards in global markets. A career in this field involves a thorough understanding of the complex processes of drug approval and registration. This includes mastering the guidelines for regions such as South East Asia, Africa, the Middle East, and the CIS countries.
Application Process
How to Apply
Interested candidates can apply by sending their updated CV to the email address below.
- Email: hr@archerchem.com
- Contact: 9028871352
Important Note: Please ensure your resume highlights any relevant experience or coursework related to regulatory guidelines, dossier preparation, or global pharmaceutical operations.
Why Join Archerchem Healthcare Pvt Ltd?
Archerchem Healthcare Pvt Ltd offers a unique opportunity for young professionals in regulatory affairs to work in a dynamic environment with exposure to international markets. With a focus on growth and compliance, this role offers a chance to develop skills in:
- Regulatory dossier preparation (CTD, ACTD, eCTD)
- Global regulatory standards
- Cross-border regulatory operations
Frequently Asked Questions (FAQs)
1. What qualifications do I need to apply?
You need to have a B.Pharm or M.Pharm degree. Fresh graduates and experienced professionals are encouraged to apply.
2. Where is the position located?
The position is based in Mumbai, India.
3. What are the key responsibilities of the role?
The role involves preparing and reviewing regulatory dossiers, understanding international guidelines, managing artwork, and coordinating with other departments to ensure compliance.
4. How can I apply?
You can send your updated CV to hr@archerchem.com or contact 9028871352 for more information.
Explore Career Opportunities in Regulatory Affairs
A career in Regulatory Affairs opens up opportunities in the pharmaceutical industry by ensuring that companies comply with global regulations. Working in this domain offers exposure to various international markets and the ability to understand the intricacies of drug approvals, making it a highly sought-after career path for B.Pharm and M.Pharm graduates.