Head of Regulatory Affairs

Netherlands, Netherlands
Mar 17, 2018
Mar 24, 2018
Contract Type
Full Time
Position: Head of Regulatory Affairs

Location: South Netherlands

Client: Our client is a Contract Manufacturing Organisation specialising in cell therapy and regenerative medicine.


To establish and lead a Regulatory Affairs department, providing regulatory support to the sites and to customers. Manager responsible for supporting regional regulatory affairs project activities within the Regulatory Affairs function. Work collaboratively with appropriate company personnel and partners to co-ordinate regulatory work stream elements. Supports the Emerging Technologies Business Unit.

Key Responsibilities:

- Provides regulatory support and advice for internal and external customers in line with defined Regulatory plans and in response to ad-hoc question to resolve regulatory issues. This will include:
- Interprets EU, US and other global regulatory requirements to support compliance in all phases of contract manufacturing of Emerging Technologies products.
- Provides technical expertise and consulting to technical and business strategies
- Functions as the regulatory contact in all direct communication with regulatory agencies.
- Supports site-specific regulatory documents and activities
- Updates functional leads and maintain transparency of information across regulatory function
- Provides regulatory support for deviation and change control activities, as appropriate
- Interprets and evaluates regulatory data to prepare documents and submissions, as appropriate
- Drafts and/or reviews customer IMPD/INDs and customer MAA/BLAs
- Provides support for scientific advice meetings and development of regulatory strategy with customers
- Works collaboratively with appropriate company personnel for the organization and prioritization of the regulatory work and CMC regulatory activities for Netherland's products and customers.
- Develops and maintains high-level contacts with external RA stakeholders including customers, regulatory authorities, academic institutions, scientific experts in regulatory and worldwide RA function.
- Anticipates, evaluates and implements trends and innovations in the RA arena.
- Perform other duties as assigned.
- Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site.
- Maintenance of ISO 9000:2000 certifications for the businesses by complying with processes, procedures and instructions for all activities in which this role participates.
- Quality should be the responsibility of all persons involved in Manufacturing. Adherence to cGMPs is required at all times during the manufacture of Emerging Technologies products.
- All personnel are responsible for notifying responsible management in a timely manner of regulatory inspections, serious GMP deficiencies, product defects and related actions (e.g. quality related complaints, recalls, regulatory actions, etc).

Skills & Experience Required:

- Bachelor's degree in biological sciences, chemistry, biochemistry or equivalent education with a minimum of 12 years industrial experience or Post-graduate degree in biological sciences, chemistry, biochemistry or equivalent education or equivalent with at least 9 years industrial experience
- Minimum 9 years of bio-pharmaceutical industry experience of which at least five should include relevant regulatory affairs experience (e.g. cell therapy, gene therapy, biologics)
- Expertise in the interpretation and communication of CMC regulatory requirements for site product and process issues
- Working knowledge of US and EU regulatory requirements for cell and gene therapy and/or biologicals
- Ability to interpret compliance requirements for the creation or review of protocols and site documentation
- Proven experience of preparing and authoring IND/CTA, BLA/MAA Module 3, and the associated CTD submissions for biological products
- Superb organizational skills and attention to detail
- Demonstrated skills managing project timelines, priorities and work under tight timelines
- Relevant coursework/certifications from Regulatory Affairs organization is desirable but not mandatory. Additional regulatory and commercialization related certificates, professional memberships, academic affiliations added advantage to the application.
- Knowledge of Health Authority and Industry trends across all areas of GXP to anticipate the needs of both the company and the customers.
- Proficient with Microsoft Office products
- Good understanding of cell and or gene therapy work processes
- Ability to review and critique complex technical documents
- Strategic approach and system oriented toward goals and objectives
- Ability to represent the company on regulatory issues both internally and externally
- Strong interpersonal skills and ability to interact positively with all functions and levels
- Excellent team leader as well as committed team member
- Strong written and verbal communication; ability to influence and present to stakeholders and customers
- Understands and explains the corporate strategy to their peers and/or team
- Sets and delivers on objectives for themselves (and their team) that support the company strategy
- Uses knowledge of their business area and related areas to make correct and timely decisions
- Uses knowledge of their own business area and related areas to identify and develop operational/financial improvements.

If you are interested in proceeding with this role, please send through your up-to-date CV in English to ****************************** and we can arrange a confidential discussion to go through your experience in more detail.