Regulatory Affairs Manager
About This Job
Position Overview
We are seeking a Regulatory Affairs Manager to oversee and enhance our regulatory activities, ensuring seamless compliance with EU filing requirements and supporting our business goals.
About the Role
As a Regulatory Affairs Manager, you will play a pivotal role in managing the Regulatory Affairs team and ensuring the successful preparation, submission, and management of regulatory documentation. You will be responsible for maintaining compliance, facilitating cross-functional collaboration, and driving strategic regulatory initiatives.
Key Responsibilities
- Lead the Regulatory Affairs team to meet company objectives and regulatory requirements.
- Oversee the preparation, submission, and tracking of EU regulatory filings, including technical documentation, amendments, and reports.
- Ensure compliance with applicable EU regulations and guidelines.
- Maintain a robust system for indexing and archiving technical documentation and correspondence.
- Collaborate with internal departments and external stakeholders to ensure timely and accurate submissions to competent authorities.
- Monitor changes in regulatory requirements and provide strategic guidance to adapt processes accordingly.
- Support cross-functional teams in addressing regulatory challenges and fostering compliance awareness across the organization.
Candidate Profile
- Education: Master’s Degree in Life Sciences.
- Experience: Minimum of 13 years of proven experience in Regulatory Affairs (RA), including team leadership or mentorship.
- Skills:
- Exceptional written and verbal communication skills to effectively convey complex scientific and medical information.
- Strong leadership and collaboration abilities with a proactive approach to problem-solving.
- Attention to detail and ability to manage multiple priorities effectively.
- Candidate must possess a valid work permit.
Benefits
- Competitive remuneration package with reviews and salary progression.
- Continuous professional development opportunities in a state-of-the-art, brand-new pharmaceutical facility.
- Comprehensive health insurance.
About Torrent Pharma Malta
Torrent Pharma (Malta) Ltd is a subsidiary of Torrent Pharmaceuticals Limited, one of the leading pharmaceutical companies in India. Having a widespread global presence in over 40 countries, Torrent Pharmaceuticals is deemed as the flagship Company of the Torrent Group.
Torrent Pharma (Malta) was established in 2021 with a strategic purpose to serve as a central hub for Torrent's sustained growth within the European market. The company fosters an environment where passion meets potential.