THE ROLE
Alira Health is a very dynamic company who aims to provide best in class regulatory services adapted to the needs of our clients. Our regulatory department is growing, and we are looking for a director in drug regulatory affairs to be a key contributor by providing sound experience in the field of drug development in the pharmaceutical industry (or consultancy).
As Director you will be responsible to manage you own clients, drive the business development of the regulatory practice and support the growth and development of a local team.
ESSENTIAL JOB FUNCTIONS
- Be in contact with client and advise to develop regulatory proposal based on their business needs
- Develop business proposal, assess and organize regulatory activities to be executed for projects
- Develop and lead regulatory activities for their own projects with support of Alira consultants, if needed
- Provide regulatory strategy advice for clinical development or registration
- Interact with health authorities
- Prepare and submit packages for regulatory agencies FDA (e.g. CTA/IND, scientific advice, Orphan drug designation, MAA experience is a plus, experience with European regulatory bodies is not required but it is welcomed
- Conduct due diligence road map or gap analyses
- Contribute to the development of the regulatory practice
- Coach development of competencies and skills of junior colleagues
- Support the VP to define the strategic orientation of the practice
- Represent Alira Health externally to congress
- Develop webinar or white papers to promote Alira Health
- Contribute to the development of a network of industry contacts
PREPARATION, KNOWLEDGE, SKILLS, AND ABILITIES
EXPERIENCE
- 5-year degree in a scientific discipline (Pharmaceutical Science, Chemistry, Biology)
- At least 10 years’ regulatory affairs experience in pharmaceutical industry (or regulatory affairs consulting) with preferably at least 3 years in a complex global environment.
DEMONSTRATED CAPABILITIES
- Hands on experience and sound understanding of regulatory processes and drug development
- Ability to lead and motivate teams
- Analytical and systematic thinking organization, with business orientation
- Highly motivated, open and agile personality able to work in an international environment
- Commitment to continuous improvement
- Organizational skills and regulatory project management skills, ability to successfully manage multiple projects to deadlines
- Excellent communication skills (oral and writing)
- Fluent in English (knowledge of second language would be an asset)
WORKING CONDITIONS/PHYSICAL DEMANDS
- Ability to travel