Invenia Group is working with a growing manufacturer of scientific instrumentation to hire a Director of Regulatory Affairs.
The company manufactures cell biology tools to advance workflows in the cell & gene therapy and bioproduction markets. They have an has an excellent culture and truly value their employees.
The role:
The Director of Regulatory Affairs will be responsible for leading the regulatory function, creating and executing compliance strategies to meet both business needs and regulatory standards. This role involves maintaining current regulatory filings, interpreting and communicating requirements, and ensuring compliance to secure governmental approvals.
Responsibilities include:
- Interpret and apply global regulations to support compliance
- Maintain and update Master Files internationally
- Develop regulatory strategies for efficient product development
- Collaborate with Legal, Quality, Manufacturing, and other teams for timely submissions
- Support project teams in addressing regulatory risks and strategizing solutions
- Establish and implement regulatory processes and best practices
- Lead communications with global regulatory authorities to resolve issues and secure approvals
- Assess and adapt strategies based on regulatory changes
- Ensure compliance with health, safety, and environmental policies
What we are looking for:
- PhD in a science related subject is preferred
- 8+ years in regulatory roles, ideally in biologics and cell/gene therapy
- Knowledge of global regulatory standards, especially FDA processes
- Experience in global DMF filings and regulatory compliance
- Strong problem-solving skills with a focus on risk-based solutions
- Excellent written and verbal communication; ability to simplify complex requirements
- Business acumen and cross-functional team experience
- In-depth knowledge of industry trends and regulatory changes
- Proven relationship-building and influence skills
If you have the experience for this role please apply to find out more
