Regulatory Services Manager
Breda, The Netherlands.
Venn Life Sciences is an Integrated Drug Development Partner offering a unique combination of drug development expertise and clinical trial design and management. This enables us to create, plan and execute drug and medical device development programs effectively and seamlessly for our clients. We have dedicated operations in Ireland, France, Germany, the Netherlands, the UK, the US, and European-wide representation.
“Our vision” is to play a pivotal role in the development of new products enabling disease prevention and treatment We do this by creating an environment that generates opportunities for employees to stretch their potential and fully exercise their talents thereby consistently providing outstanding service to our clients. We nurture an environment of respect, pro activity, teamwork and above all keep the patient at the heart of what we do.
We are looking for a Regulatory Services Manager to join our team. Based in our office in Breda, the Netherlands, the role holder will be responsible for providing Regulatory affairs consulting and managing regulatory affairs activities for the Venn group. They will be responsible for developing, facilitating and executing comprehensive regulatory strategies through all phases of development lifecycle for clients, internal & external.
Responsibilities & Accountabilities:
- Establish, lead, grow and manage Regulatory Affairs activities and consulting.
- Provide overall strategic direction and leadership on Regulatory Operations and Regulatory Consulting for the Venn Group.
- Lead the development and creation of Regulatory Intelligence activities.
- Provide consultation, support and regulatory expertise as needed to internal and external customers in support of drug development, clinical trial applications and market authorisation applications globally.
- Interpret and effectively deal with complex regulatory issues across Venn’s strategic business activities in support of departmental and corporate goals.
- Provide technical leadership and vision through the interpretation of new and emerging international regulatory trends pertinent to business needs and develop and implement strategies and projects to optimise regulatory services.
- Provide leadership and oversight of Regulatory Affairs Services including but not limited to: INDs, IMPDs, CTAs, NDAs, Orphan Drug Applications, BLAs, and MAAs, (and amendments/maintenance for all the listed submissions, like Annual Reports), Briefing Documents (in support of IND/Scientific Advice meetings), Ancillary submissions like Special Protocol Assessment, Fast Track, Breakthrough Designation, etc.
- Establish and provide leadership for medical device services to include, but not be limited to: Product registration, global regulatory submission strategy, regulatory driven research and development consultancy.
- Ensure the appropriate resources and partners are identified on a global basis to meet client needs requiring a full range of regulatory expertise.
- Support Business Development and attend key client meetings/presentations to provide regulatory input, present regulatory capabilities and assist in securing the business.
- Preparation of proposals in liaison with Business Development.
- Liaise with regulatory agencies worldwide.
- Oversee the preparation, completion and filing of high-quality regulatory submissions within the agreed timelines and budget.
- Ensure regulatory compliance in all operations & creation of regulatory affairs SOPs as required.
Key Capabilities Required:
Qualifications & Experience:
- PharmD or PHD in life sciences or chemistry or equivalent.
- Minimum 7-10 years’+ senior Regulatory Affairs leadership in a pharmaceutical company or CRO with a proven track record of regulatory successes & strong commercial acumen.
- Experience of delivering a range of medical devices from proof of concept through to registration studies with a specific focus on start-up and university spin-out companies.
- 5+ years effectively managing and leading teams.
- Previous experience working in a matrix organisation an advantage.
- Demonstrated strategic thinking, business acumen and process assessment capability.
- Strong interpersonal skills including the ability to build authentic relationships, constructively challenge conventional thinking, engender trust, influence key stakeholders, cooperate as a team leader or team member, share information and deliver results with a team.
- Organisational agility (knowledgeable about how an organisation works) and ability to apply that capability to lead change, deliver strong results and build the confidence and trust of stakeholders.
- Excellent influencing, organisational and management skills with ability to listen, lead, manage and motivate a team particularly across a multicultural organisation.
- Ability to deal with complex, conflicting priorities and develop coherent, effective solutions.
- Demonstrates significant judgement and decision-making capability with the ability to make difficult, but robust, rationalised and timely decisions balancing the totality of available data and risk.
- Professional who is experienced and dependable with discretion, enthusiasm and a positive attitude.
- Fluent English.
- Flexibility to travel
We offer an employment with excellent primary and secondary conditions. In our organisation, you can acquire a high level of responsibility and independency, broaden your knowledge, experience and expertise and work in close collaboration with our other development departments.
How to apply:
Please forward your CV (in English) by email to Liane Brown-Feaheny, email@example.com
PLEASE NOTE THAT DUE TO THE HIGH VOLUME OF APPLICATIONS WHICH WE RECEIVE WE WILL ONLY BE ABLE TO REPLY TO CANDIDATES WHOM WE ARE INVITING FOR INTERVIEW.
We do not require the services of agencies for this role.