Senior Regulatory Affairs Specialist

About the Company: Mendine Pharmaceuticals Pvt. Ltd. – operating with its glorified journey of eight decades since 1+37 (the then Mendine Pharmaceutical Works) in India with a stretch of its business network in Eastern North Eastern India and part of Eastern U.P. Our horizon of expertise expands from cutting edge allopathic to age-old traditions of India – the Ayurveda Drugs. We have an ISO:+001:2015, WHO GMP certified Manufacturing, Research and Development set-up of our own with a wide range of Pharmaceutical, Nutraceutical and Food Supplement Products. We have also an SBU (Strategic Business Unit) viz., Mendine Lifecare Products Pvt. Ltd. - which focuses on ethical products promotion. We, at Mendine, always believe in retaining the goodwill of customers and spreading knowledge about good health and life. Our ethos is to perform with integrity and we believe in competitive compliance by building a newer and healthier tomorrow with adequate and intensive research works. We consistently aim at tracking new technologies to augment the quality of life and bring smile to our consumers’ faces and also educating our employees for up-skilling with enhancement of knowledge in accordance with the same.

Job Objective : A Regulatory Affairs Specialist's job description involves ensuring a company's products and operations comply with relevant regulations, laws, and guidelines.

Responsibilities:
• Responsible for monitoring regulatory changes, preparing and submitting documents to regulatory agencies, and providing guidance to internal teams on compliance.
• This role also includes assessing compliance, recommending remediation, and acting as a liaison between the company and regulatory agencies.
• Responsible for preparing and submitting various documents, including product registration dossiers, clinical trial documentation, Endorsement approval COPP product wise approval and other regulatory submissions.
• Co-ordination for external audit with external Regulatory Agency with Regularity guideline awareness.

Qualifications:
• B. Pharm/M pharm/MSc.
• Minimum 5-8 Yrs. Experience in RA

Preferred Skills:
• Regulatory Affairs roles require a blend of technical and soft skills.
• Strong analytical and problem-solving abilities are crucial for interpreting regulations and addressing complex issues.
• Effective communication, including writing and presentation skills, is essential for interacting with regulatory bodies and internal teams.
• Additionally, strong skills are needed to coordinate submissions and ensure compliance with deadlines.

Pay range and compensation package: Pay range and compensation package will be negotiable based on present package Industry norms.

Equal Opportunity Statement: We are committed to diversity and inclusivity in our hiring practices. Read more