Exciting Opportunity: Officer/Executive – RA EU at Lupin in Maharashtra
Location: Maharashtra, India
Date Posted: August 31, 2024
Company: Lupin
Job Overview
Lupin is seeking a motivated Officer / Executive – RA EU to join our Regulatory Affairs team. This role is crucial for managing regulatory submissions and maintaining compliance for our products in European, Australian, New Zealand, and Canadian markets (EANC). You will work closely with various departments and regulatory agencies to ensure our products meet the necessary standards and achieve approvals.
Key Responsibilities
As an Officer / Executive – RA EU, you will be responsible for the following:
1. Preparation of Dossiers
- Create and Compile Dossiers: Develop and prepare regulatory dossiers for submission to regulatory agencies in Europe, Australia, New Zealand, and Canada.
- Documentation: Ensure all required documentation is complete, accurate, and in compliance with the respective regulatory guidelines.
2. Response to Regulatory Queries
- Address Queries: Respond to queries from regulatory agencies and customers in EANC advanced markets.
- Coordination: Liaise with relevant stakeholders to gather information and provide timely and accurate responses.
3. Collaboration with Internal Teams
- Cross-functional Liaison: Work closely with Research & Development, manufacturing plants, clinical teams, and EANC offices/Business Development (BD) teams to facilitate regulatory processes.
- Information Sharing: Ensure smooth communication and coordination between different departments to support regulatory activities.
4. Product Lifecycle Management
- Variation Approvals: Assist in managing the lifecycle of registered products in EANC markets, including obtaining approvals for variations and updates.
- Monitoring: Track and manage changes and updates to regulatory requirements and product status.
5. Maintenance of Department Databases
- Database Management: Maintain and update departmental databases to ensure accuracy and availability of regulatory information.
- Record Keeping: Ensure all regulatory submissions and communications are documented and stored appropriately.
6. Regulatory Guidelines Study
- Guideline Review: Regularly study and stay updated on regulatory guidelines, electronic submission requirements, and other relevant regulations.
- Continuous Learning: Keep abreast of changes in regulatory requirements and industry standards to ensure compliance.
Qualifications
Experience
- Relevant Experience: 1 to 2 years of experience in regulatory affairs, preferably in the pharmaceutical industry.
- Experience with EANC Markets: Familiarity with regulatory requirements and processes for European, Australian, New Zealand, and Canadian markets is advantageous.
Education
- Degree: Bachelor’s Degree in Pharmacy (B. Pharma) or a related field.
Why Join Lupin?
At Lupin, we are committed to creating an environment where our employees can grow and make a significant impact. As part of our Regulatory Affairs team, you will have the opportunity to work on challenging projects that contribute to our mission of delivering high-quality pharmaceutical products globally.
Our team is dedicated to fostering a collaborative and inclusive work culture where each member’s contribution is valued. If you are passionate about regulatory affairs and eager to be part of a leading pharmaceutical company, we encourage you to apply.
How to Apply
Interested candidates can apply directly through our Lupin Careers page. Join us in our journey to advance healthcare and make a difference in people’s lives.
Pursue excellence with Lupin.
Lupin is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.