Regulatory Affairs Associate Director/Director
Reports to: Technical Director
Contact: careers@diamondpharmaservices.com
Job Description
The Regulatory Affairs Professional provides development stage advice to internal staff and to clients for a broad range of programmes. They will provide the following expertise based services:
- Lead EMA procedures including orphan applications, PIPs and MAAs
- Point of contact for agency interaction
- Provide expert EU regulatory strategy
- To be a client lead
- Provide leadership in scientific advice meetings at national agencies and EMA
- Project management/lead responsibilities
- Client facing with strong communication skills, willing to travel
- To assist the senior management team by providing leadership support to a team of internal consultants and their clients
- To assist the company in providing regulatory knowledge to business development colleagues during bid defence
Key Responsibilities and Duties
- Provide world-class advice in EU regulatory affairs maters across a range of product types
- Lead EMA procedures including orphan applications, PIPs and MAAs
- Provide expert EU regulatory strategy
- Regulatory lead and point of contact for national agency and EMA interactions
- Advise global clinical development teams in the requirements for EU based programmes, and to integrate with other regional experts.
- Provide development related strategy for a broad range of programmes
- Provide direct line management and matrix team based leadership where needed
- High level of client focus and accountability
- Assist with Business Development activities by taking part in new prospective client-lead discussions
Professional Experience
Essentials:
- Degree or higher in Chemistry, Biochemistry, Biology or related scientific disciplines
- 5+ years broad & deep European regulatory affairs experience in development stage programmes
- Demonstrable experience in liaising and negotiating with regulatory authorities and point of contact with EMA
- Demonstrable experience in centralised MAAs, orphan applications and PIPs.
- Strong understanding of the regulatory environment including guidelines
- Ability to lead team members in a matrix management environment
- Ability to work under pressure and achieve timely submission and regulatory approvals
- Excellent computer skills
- Collaborative approach and able to work effectively with matrix based teams involving internal staff, client teams that include independent consultants
- Confident speaker about regulatory challenges in EU and global pharmaceutical development, and able to communicate effective solutions to clients.
Preferences:
- 7+ years of experience in regulatory affairs based activities and regulatory authority interactions
- US FDA facing experience
Personal Attributes
- Innovative and pragmatic problem solver
- Attention to detail
- Strong communicator with the ability to influence
- Completer-finisher able to provide decisive leadership in a project team setting
- Ability to provide a flexible, proactive and dedicated approach whilst dealing with clients with different working styles and cultures.
- Strong client focus