Associate Director Regulatory Affairs

The organisation
   
Our client is a clinical-stage Biopharmaceutical company focused on Biologicals and is looking for an Associate Director Regulatory Affairs. The organisation has involved new key positions with large Pharma / Biotech Phase III and commercial experience. The focus is on Operational Excellence and flawless execution of pivotal studies to deliver a quality market authorisation submission package as well as preparing for commercial launch in selected countries. The bandwidth of the organisation will allow for expanding the pipeline and/or accommodating new strategic opportunities.

The position

To support the expansion of the business, we are currently looking for an Associate Director Regulatory Affairs. Within the organisation you will work together in a constructive, collaborative and team-oriented way, towards achieving the company objectives without losing sight of our own objectives. The organisation puts the common interest of the company and the patient above our own individual interests. They set high standards regarding the quality of the materials, processes, documentation and collaborations, the staff is motivated to deliver excellence whilst also working to continually improve the quality of the work. They are fully accountable for the things that are in our power and control while working on the goals of the organisation. There is an obligation to proactively report, explain and justify the things we do. They accept responsibility for our performance, and we are transparent about the results of our work. There is an understanding of how to cope effectively with setbacks and obstacles and overcome hurdles on the way to reach the common goal. They stay committed to agreed objectives and company culture despite resistance while having the strength to adjust the plans when necessary. The team is tolerant to stress, and they deal effectively with criticism and resistance, building on our own strength.

Within the organisation the Associate Director Regulatory Affairs plays an important role in bringing to market our potential life-saving medical treatment. You will have the opportunity to work together with a team of professionals within our collaborative and positive company culture.

Tasks & responsibilities

Reporting to the VP of Regulatory Affairs and Quality Management, you will:

• Manage the preparation and compilation of BLA/MAA submissions in US, EU and Japan
• Manage the filing of CTAs including management of responses to authority questions and submission of CTA amendments together with the clinical development team and the CRO
• Assemble and maintain clinical, nonclinical and CMC development information repository to allow efficient retrieval of development reports, protocols, specifications, and other relevant documentation
• Manage Paediatric Investigation Plan (PIP) activities, including iPSP follow-up in the US
• Bring up-to-date knowledge on regulatory guidelines, document management and archiving policies and share this with the development team 
• Coordinate and support the interaction with (inter)national health authorities, agency meetings and prepare contact reports and meeting minutes
• Support the team with developing regulatory strategies and contribute to scientific advice
• Write, review scientific and clinical development reports for regulatory compliance

Candidate profile

We expect the Associate Director Regulatory Affairs to:

• Bring relevant regulatory experience in a drug development setting
• Have the ability to handle multiple tasks efficiently and effectively
• Have good communication skills with ability to work in a small and professional team environment
• Have strong interpersonal skills and high attention for detail
• Be proficient in English

The offer

The company can offer you:

• Remuneration at market level + excellent benefits
• Contract for indefinite time
• 5% to 10% bonus (performance-based)
• Excellent pension
• 30 holidays per full calendar year

Interested?

You can apply to this position by using the link below. For more information please contact Aron Berhane, +31 23 754 86 60.