Job Description
Reporting to the Executive Director, Regulatory Affairs (US), the Regulatory Affairs Director Europe will be responsible for developing and implementing regulatory strategies and planning, managing and executing regulatory activities for approved and pipeline products within Europe.
Job Spec
- Define and execute strategies for post-marketing regulatory submissions and required maintenance (amendments, notifications, variations, renewals, annual updates) for drug products in the EU
- Draft EU specific documentation needed for submissions and work with RegOps consultants to submit to Health Authorities in a timely manner
- Work with CRO to manage and review customization of CTA dossiers for pipeline products
- Support the writing and review of EU SOPs and assist in inspection readiness of the EU office
- Serve as a liaison with the EMA for marketed products
- Educate project teams on regulatory pathways and requirements to ensure effective product development and registration
- Maintain an effective archiving system
- Stay current with EU legislation and guidance
- Provide training on specific regulatory topics, as needed
- Support contractor selection and coordination of contracted activities
Person Spec
- PharmD, PhD, Masters or Bachelors degree, preferably in life sciences
- 10+ years of Regulatory experience, with several years in a similar EU-based leadership role
- Experience with rare diseases/orphan designated products
- Ability to oversee regulatory activities and manage process from research/discovery, clinical development through to commercialization
- Experience with overseeing CTA submissions and maintenance
- Knowledge of EU expedited programs
- Post marketing/ life-cycle management experience (Variations, Renewals and Labelling) preferred
- Regulatory project management experience
- Demonstrated leadership to drive results that are needed to achieve company objectives
- Must possess excellent interpersonal skills, successfully collaborating across geographies, cultures and functional areas
- Must have the ability to build and maintain positive relationships with management, peers, and direct reports
- Excellent written and verbal skills.
- Up to 20 % travel required: US and Europe