Regulatory Affairs Specialist
Role Overview
This position is responsible for supporting regulatory activities across a portfolio of generic pharmaceutical products, ensuring full compliance with applicable European regulatory standards. The role involves oversight of product development documentation, preparation of regulatory submissions, and collaboration with both external partners and regulatory agencies. Experience with DCP procedures, dossier preparation, and generic product development is essential.
Key Responsibilities
- Execute regulatory affairs tasks in alignment with current EU and international regulatory requirements.
- Prepare and compile Common Technical Documents (CTDs) for regulatory submissions.
- Coordinate with contract development and manufacturing organizations (CDMOs) to support product development and manage related projects.
- Communicate with European regulatory authorities regarding dossier submissions and queries.
- Stay up to date with evolving pharmaceutical regulations and guidance.
- Collaborate with internal teams and third-party partners to facilitate product development, documentation, and successful market launch.
- Ensure adherence to the Quality Management System for all regulatory processes.
- Generate monthly performance reports and project metrics.
- Contribute to team meetings and keep management informed of developments affecting regulatory or business timelines.
- Participate in knowledge-sharing initiatives and cross-functional training.
- Support daily departmental operations and assist in achieving project milestones.
Requirements:
- Degree (or higher) in a scientific field such as Chemistry, Microbiology, or related discipline.
- Minimum of 2 years' experience in regulatory affairs within a regulated pharmaceutical environment, ideally in the generic medicines sector.
- Solid knowledge of European and international regulatory frameworks, including EMA and ICH guidelines.
- Understanding of regulatory planning and familiarity with end-to-end processes in generic product lifecycle.
- Experience contributing to regulatory strategies and working with cross-functional teams.
- Proficiency in preparing regulatory documentation and technical writing.
- Strong problem-solving and analytical thinking.
- Experience working within a Quality Management System.
- Excellent communication and interpersonal skills.
- Proactive attitude with a focus on continuous improvement.
- Ability to influence and collaborate effectively to achieve project goals.
