Assoc. Director Reg. Affairs, EU Affiliates Liaison応募 後で応募 求人ID R0014274 掲載日 11/14/2019 Location:Zurich, Switzerland
Associate Director Regulatory Affairs, EU LOC Liaison
- Build strong relationships with EUCAN Local Operating Company Regulatory Affairs (LOC RA) network to help identify risks, trends impacting Regulatory Affairs in the region and facilitate best practice sharing between LOC RAs and EUCAN Regional RA and GRA and aid introduction of relevant tools and processes for knowledge and information exchange
- Support and help drive GRA and EUCAN RA initiatives for the minimization of risk to local and EUCAN region regulatory compliance. Drive to find solutions for risks identified within LOC RAs (outside of local resourcing constraints)
- Support EUCAN RA team as point of escalation for issues relating to EUCAN LOC RA. Ensure communication and help drive strategic advice of EUCAN regulatory programs and submissions as agreed with EUCAN Therapy Area and Marketed Product EUCAN Leads.
- Act as EU LOC escalation point for risks and emerging challenges. Facilitate EUCAN Regulatory Leads (RLs) connection with LOC RA teams and working collaboratively together with other functions to facilitate implementation of regulatory submissions, product strategy and process change initiatives as needed in local countries.
- Facilitate best practice sharing between LOC RAs and between LOC RAs and Regional RA/GRA and, in collaboration with GRA Communications, aid introduction of relevant tools and processes for regulatory knowledge and information exchange between LOCs and between LOCs and global/Regional RA
- Establish and maintain frequent formal channels of communication and interaction with LOC RAs, co-creating meeting agenda for Regional RA internal conferences with Global R&D and EUCAN commercial stakeholders.
- Support and help drive GRA and EUCAN RA initiatives for the minimization of risk to local and EUCAN region regulatory compliance:
- Facilitating GRA functions to drive compliance initiatives and support the root cause investigation for risks or process deviations identified regulatory changes on Regional/Global RA systems
- Build a strong understanding of LOC RA operating models and capabilities, to better assess the impact of any GRA or EUCAN regulatory changes on LOC RA systems and processes
- Ensure list of LOC RA contacts are kept up to date according to agreed process and manage common accessible platform for the sharing of EUCAN LOC and Regional RA tools and information
Proactively builds/strengthens internal (i.e. LOC RAs) and external stakeholder relationships and networks (Regulatory Agency, external experts, industry organizations, etc) contacts/influence to achieve Takeda strategic goals and objectives within the EUCAN Region.
- Maintain awareness of the Regulatory environment and emerging trends
- Responsible for demonstrating Takeda leadership behaviors
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Life science degree or equivalent
- Strong networking and relationship building skills
- Strong knowledge of regulations for the pre- and post-marketing global environment and European legislation and procedures (national, decentralized and mutual recognition procedures) in particular
- Experience of working in a RA HQ function and/or in LOC-RA
- Excellent written/ oral communication skills
- Flexible mindset
- Team worker with collaborative approach
- Ability to prioritize under pressure
- Well developed organizational skills
- High standard of computer literacy
- *30% mainly European, international if needed.