Rubicon Research Hiring for Regulatory Affairs
| Job Title | Sr. Executive, Regulatory Affairs |
|---|---|
| Company | Rubicon Research Limited |
| Location | Thane, Maharashtra, India (On-site) |
| Experience | 6+ years |
| Education | B.Pharm, M.Pharm |
| Key Responsibilities | Regulatory submissions, eCTD dossier preparation, compliance reporting |
| Job Highlights | Work/Life Balance, Flexibility, Time Management, Problem Solving |
| Application | Apply online (link provided on job listing) |
| Verified Job | Yes |
Elevate Your Regulatory Career: Sr. Executive Role at Rubicon Research Limited
Rubicon Research Limited, a leading pharmaceutical company, is offering an exciting opportunity for a Sr. Executive, Regulatory Affairs to join their team in Thane, Maharashtra. This role is crucial to ensuring regulatory compliance throughout all stages of the product lifecycle and involves working on high-profile submissions for the US FDA, Health Canada, and the European Medicines Agency (EMA).
If you have over 6 years of experience in regulatory affairs, particularly in ANDA and NDA submissions, and are looking for a challenging and rewarding career in a dynamic work environment, this could be the perfect role for you. Rubicon Research Hiring for Regulatory Affairs
Key Responsibilities of a Sr. Executive, Regulatory Affairs
As a Sr. Executive in Regulatory Affairs at Rubicon, you’ll play a vital role in ensuring that the company’s pharmaceutical products meet global regulatory standards. Here’s a closer look at your responsibilities: Rubicon Research Hiring for Regulatory Affairs
Labeling and Documentation:
You’ll be tasked with reviewing product labels and Summary of Product Characteristics (SPL) to ensure they meet regulatory requirements for various markets. Rubicon Research Hiring for Regulatory Affairs
Regulatory Submissions:
Your primary responsibility will be to prepare, compile, and submit pre- and post-approval documents, including those for the US, EU, and Rest of World (ROW) markets. This includes managing eCTD dossiers for USFDA ANDA and EU-MAA applications.
Data Gathering and Validation:
You’ll collaborate with internal stakeholders to gather essential data, such as batch records, method validation, and other analytical documentation needed for regulatory submissions.
Regulatory Correspondence:
Managing regulatory correspondence is another key responsibility. You’ll respond to deficiencies raised by regulatory authorities, ensuring that all queries are resolved in a timely and accurate manner.
Compliance Reporting:
In this role, you’ll also be responsible for preparing and submitting regular compliance reports, such as Annual Reports and Periodic Adverse Drug Experience Reports (PADERs), ensuring that all products maintain the highest safety standards. Rubicon Research Hiring for Regulatory Affairs
What You’ll Need to Succeed in This Role
To excel in the Sr. Executive, Regulatory Affairs position, you’ll need a combination of experience, education, and specific skills. Below are the qualifications you should meet:
- Education: You must hold a B.Pharm or M.Pharm degree.
- Experience: A minimum of 6 years of hands-on experience in regulatory submissions, especially for the USFDA, ANDA, and European markets.
- Technical Skills: Strong experience managing ANDA/NDA submissions, including the preparation of eCTD dossiers.
If you have the required background in regulatory affairs, particularly in working with regulated markets like the US and EU, this position will offer you the opportunity to further hone your expertise. Rubicon Research Hiring for Regulatory Affairs
Why Join Rubicon Research Limited?
Rubicon Research Limited provides a collaborative work environment where you will be exposed to regulated markets across the globe. This role allows you to work closely with cross-functional teams in both India and the US, providing you with diverse insights and experience in global regulatory compliance.
Additionally, Rubicon offers opportunities for training and development, allowing you to grow in your role and build a long-term career in the pharmaceutical industry. Whether you’re looking for an opportunity to broaden your skill set or deepen your regulatory expertise, Rubicon provides a supportive platform for your professional growth. Rubicon Research Hiring for Regulatory Affairs
How to Apply
If you meet the qualifications and are excited to take the next step in your regulatory career, apply online through the link provided in the job listing. Make sure your application highlights your regulatory submissions experience, especially in USFDA ANDA and NDA filings.
This is a fantastic opportunity to grow with a dynamic and fast-expanding company. Don’t miss your chance to be part of Rubicon Research Limited’s mission to innovate and elevate healthcare solutions across the globe!
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