Job Summary: Executive – Regulatory Affairs
- Role: Executive – Regulatory Affairs
- Company: Lupin Biotech
- Location: Ghotawade, Pune, Maharashtra, India
- Experience Required: 2–3 Years
- Industry: Biotechnology / Pharmaceutical Regulatory Affairs
- Education: Postgraduate in Biotechnology or Biochemistry; Undergraduate in Biotechnology or Biopharmaceutics
Position Overview
Lupin Biotech is currently seeking a diligent and detail-oriented professional to join our team as an Executive within the Regulatory Affairs department. Based at our facility in Ghotawade, Pune, this role is critical to ensuring that our innovative biotechnology products meet the highest standards of safety, efficacy, and regulatory compliance.
The ideal candidate will play a pivotal role in the preparation, review, and submission of regulatory documentation. You will work closely with cross-functional teams to ensure that all internal processes align with evolving global regulatory requirements. This is an excellent opportunity for a professional with 2–3 years of experience in the pharmaceutical or biotechnology sector to contribute to a leading global organization that prioritizes patient health through scientific excellence.
Key Responsibilities
As an Executive in Regulatory Affairs, your core responsibilities will include:
- Regulatory Submissions: Preparing and managing the compilation of regulatory dossiers and submissions for biotechnology products. You will ensure that all data is presented accurately and adheres to regional and international regulatory guidelines.
- Documentation Management: Overseeing the lifecycle of regulatory documents, including internal review processes, tracking changes, and ensuring the integrity of all technical data.
- Compliance Monitoring: Staying updated on regulatory policies and ensuring that our products and procedures remain compliant with current Good Manufacturing Practices (cGMP) and other relevant regulatory standards.
- Internal Collaboration: Working effectively with research and development, quality assurance, and production departments to gather necessary information, troubleshoot submission-related challenges, and ensure the timely filing of applications.
- Problem-Solving: Identifying potential regulatory roadblocks and proactively proposing solutions to ensure a smooth approval process for new products or post-approval changes.
- Communication: Acting as a point of contact for regulatory activities, ensuring that all stakeholders are kept informed of status updates and regulatory requirements.
Required Qualifications and Skills
To be considered for this position, applicants must meet the following criteria:
- Educational Background:
- Postgraduate degree in Biotechnology or Biochemistry.
- Undergraduate degree in Biotechnology or Biopharmaceutics.
- Professional Experience: A minimum of 2–3 years of hands-on experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Technical Knowledge: A strong understanding of regulatory frameworks, dossier preparation, and the drug development lifecycle for biological products.
- Communication: Exceptional written and verbal communication skills, with the ability to articulate complex technical information clearly and professionally.
- Analytical Ability: Strong attention to detail and analytical skills, allowing for the accurate review of complex scientific data.
- Adaptability: Ability to thrive in a fast-paced environment and manage multiple priorities simultaneously to meet strict project deadlines.
Why Join Lupin Biotech?
At Lupin, we are committed to providing quality healthcare through innovation and accessibility. Joining our Regulatory Affairs team provides you with the opportunity to work on complex, life-changing biotechnology projects. We foster a culture of professional growth, encouraging our employees to develop their expertise in a highly regulated and scientifically rigorous environment. You will be supported by a team of experienced professionals and given the resources needed to succeed in your career.
How to Apply
If you meet the above requirements and are passionate about building a career in regulatory affairs, we invite you to submit your application.
Please email your updated resume to [email protected].
In your email, kindly use a clear subject line indicating the position title for which you are applying. Ensure that your resume highlights your relevant experience in regulatory documentation and your understanding of biotechnology products. We thank all applicants for their interest; however, only those selected for further consideration will be contacted.
Lupin is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.