Regulatory Affairs Manager oversees the regulation process for products requiring governmental approval, including filing necessary applications and handling all government interactions. Coordinates inspection of the organization and contract facilities, and develops procedures to ensure regulatory compliance. Being a Regulatory Affairs Manager requires a bachelor’s degree in area of specialty. Typically reports to top management. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. Extensive knowledge of department processes. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 to 3 years supervisory experience may be required.
Regulatory Affairs Manager Job Description Template
Our company is looking for a Regulatory Affairs Manager to join our team.
Responsibilities:
- Review all submissions compiled by other team members prior to dissemination to Health Authorities, country distributors or external partners;
- May lead the development of new systems and procedures, as the Regulatory Affairs Manager;
- Develop talent within the team to increase performance. Actively address performance issues on team;
- Maintain Current knowledge of EU & International regulation & guidances;
- Interpret regulations and guidelines and communicate them to other team members and departments;
- Managing labelling development, clinical summaries and risk minimisation activities;
- Budget Management;
- Work closely with the team to implement a regulatory strategy and ensure submissions are sent to Health Authorities within required timeframes;
- To lead teams to support the regulatory processes for market access of products;
- Manage a small team of regulatory professionals;
- Reporting to the Head of Corporate Regulatory Affairs;
- Contributing to Regulatory Intelligence, stay up to date on local and EU laws and assess the impact on local business and products;
- Ensuring that product development is aligned with the company’s strategy business model as well as global regulatory requirements;
- Provide strategic regulatory input into the business;
- Working with other functions as necessary, contribute to the preparation and content of high-quality regulatory dossiers.
Requirements:
- Ability to work independently but contribute pro-actively to a project team;
- Oncology, haematology, orphan diseases and immunology experience preferred;
- Minimum 7 years’ experience- with 3 years preferably in supervisory positions;
- Experience in both EU and US regulatory affairs;
- Have a rounded regulatory knowledge;
- In depth knowledge of applicable laws, regulations and codices for pharmaceutical industry;
- Excellent interpersonal Skills;
- Demonstrable multitasking, project management, and execution skills;
- Good interpersonal skills, including communication, presentation, persuasion, and influence;
- Fluent written & spoken German, French & English / Italian as additional national language is a plus;
- Good working knowledge of the pharmaceutical industry;
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment;
- Strong strategic experience within Regulatory Affairs;
- Cultural awareness and sensitivity to achieve results across both regional country and international borders;
- Strong communication and interpersonal skills.