Are you a pharmacy graduate eager to kickstart your career in the dynamic pharmaceutical industry? Lupin, a leading global pharmaceutical company, is hiring a Regulatory Affairs Officer in Mumbai. This entry-level role offers hands-on experience in regulatory submissions, compliance, and drug safety, making it ideal for freshers with a passion for pharma regulations. With Lupin’s focus on innovation and affordable medicines, this position is a gateway to building a healthier world while advancing your professional skills.
Responsibilities
As a Regulatory Affairs Officer at Lupin, you’ll play a crucial role in ensuring compliance with pharmaceutical regulations. Key duties include:
- Supporting regulatory submissions such as annual reports, supplements, and new product launches.
- Assisting with labeling amendments and responses to Discipline Review Letters (DRL) or Information Requests (IR).
- Contributing to complete response amendments and dossier compilation.
- Maintaining awareness of quality guidelines, including ICH-GCP, and ensuring adherence to regulatory standards.
- Collaborating on drug safety, pharmacovigilance, and clinical trial processes to uphold regulatory compliance in the pharmaceutical sector.
Qualifications
To qualify for this Regulatory Affairs Compliance role, candidates should meet the following criteria:
- Education: Graduation in Pharmacy or Masters in Chemistry.
- Experience: Fresher to 1 year, with dossier compilation experience or awareness of quality guidelines preferred.
- Skills: Proficiency in eCTD, regulatory submissions, USFDA, ISO, ICH-GCP guidelines, drug safety, pharmacovigilance, RACTD, clinical research, case processing, quality assurance, regulatory affairs, ARGUS, MedDRA, drug regulatory affairs, and clinical trials.
- Competencies: Customer centricity, developing talent, collaboration, strategic agility, process excellence, stakeholder management, innovation & creativity, and result orientation.
Benefits
Joining Lupin as a Regulatory Affairs Officer comes with numerous perks tailored for professional growth in the pharma industry:
- Competitive salary and benefits package in a Fortune India 500 company.
- Opportunities for skill development in regulatory affairs and pharmaceutical compliance.
- Work in a collaborative environment with a focus on innovation and employee well-being.
- Exposure to global operations in over 100 countries, enhancing your pharma career prospects.
- Access to Lupin’s values-driven culture, promoting work-life balance and personal development.
Application Instructions
Interested candidates can apply for this full-time, permanent Regulatory Affairs Officer position at Lupin in Mumbai. Register or log in on the job portal to submit your application. Ensure your resume highlights your pharmacy education, regulatory awareness, and relevant skills. Applications are open now, with over 100 applicants already interested—don’t miss this chance to join a top pharmaceutical company!