Associate Director Regulatory Affairs Biosimilars

The organisation
   
For a global biotech specialised in the discovery, development and delivery of innovative therapies, we are currently looking for an Associate Director Regulatory Affairs focusing on Biosimilars.

The position

You will be accountable for the following:

• Responsible for directing global regulatory strategies for assigned projects and programs through the development and execution of the GRP
• Direct global pre-clinical and clinical regulatory strategies
• Direct global life cycle management of products
• Support development of the late stage clinical development plan and advise on CTA submission strategy
• Set strategic direction and lead global regulatory submission process with submission teams, including marketing applications and core briefing packages
• Identify and assess regulatory risks associated with product development. Define strategies to mitigate risks
• Provide regulatory guidance to company personnel throughout the research and development process
• Develop and maintain the Core Data Sheet and lead global labelling team meetings
• Collaborate closely with Regulatory CMC on related filing content, strategies and risk mitigations
• Assess impact of proposed CMC changes to licenses or clinical trial applications

Candidate profile

We are looking for someone with the following qualifications:

• BS degree in pharmacy, chemistry, biology, pharmacology or related life sciences subject is required
• 8 years pharmaceutical/biotechnology industry experience with technical management experience. Minimum of 6 years in Regulatory Affairs (Strategy)

Experience:

• Working on products regulatory aspects of products in pre-clinical and clinical development
• Late stage development regulatory experience, including leading a significant submission (eg NDA or BLA, MAA). Prior experience as a regional regulatory lead, ideally US and/or EU in pharma
• Direct experience in interfacing with relevant regulatory authorities (e.g. FDA, EMA, and PMDA)
• Biosimilars preferred
• Good knowledge of applicable regulations and experience in interpretation of regulations, guidelines, policy statements, etc
• Foster effective, positive interactions with regulatory agencies, and corporate partners
• Ability to lead and influence project teams, committees, etc. to attain group goals
• Demonstrate strong organisational skills, including the ability to prioritise personal workload
• Strong interpersonal skills and the ability to deal effectively with a variety of senior personnel including medical, scientific, and manufacturing staff
• Strong sensitivity for a multicultural/multinational environment. Experience leading multidisciplinary teams
• Supervisory/mentoring experience, including ability to guide, train, supervise and prioritise workload of direct reports (as applicable)

The offer

In return for your work, the organisation can offer the following:

• Being part of a stable and fast growing organisation
• An environment that is dynamic, offering you room to develop many different skills and providing your own input in the development of processes
• Excellent personal and growth opportunities
• Bonus up to 15% + LTI + Car 
• Work remote, or partially in the office

Interested?

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