Associate Director, Regulatory Processes

Act as technical writers and project management support to ongoing procedural Working with the Processes Directors, taking responsibility for the management of assigned AstraZeneca projects, processes including implementation, communication, compliance, performance and inspection readiness. Accountable to develop relationships across Regulatory Affairs and other relevant areas of AZ to execute the delivery of the processes strategy, priorities, alongside governance and management of the current procedural documents.


RESPONSIBILITIES:
• Support authoring and Project Management of procedural document such as Standard Operating Procedures, Work Instructions and Best Practice documentation
• Identify opportunities for and drives the enhancement of existing processes through knowledge of internal and external environment.
• Working with the Process Directors, and Patient Safety and Regulatory experts, develop, establish, monitor, report and assess global KPIs related to safety and regulatory data reporting.
• Utilise safety and regulatory knowledge to maintain and support the global inspection readiness strategy.
• Using deep understanding of regulatory and pharmacovigilance processes and regulations provide process or compliance support to regulatory teams and submissions.
• Identify opportunities to improve and simplify the methodology in processes and guidance, provide practical solutions and drive to implementation.
• Identify and promote innovation and new ways of working to drive efficiency and improved deliverables in all processes
• Identify issues and risks and propose options to mitigate them.
• support activities required to prepare for or in response to for GVP, GCP, GRP and GMP audits/inspections
• Provide process training to relevant functional groups.
• Contribute to communication and change management activities associated with process initiatives.
• Working collaboratively to provide expertise and sharing best practices across all regions.

 

EDUCATION, QUALIFICATIONS, SKILLS AND EXPERIENCE:

ESSENTIAL
• A SCIENCE/PHARMACY/NURSING DEGREE, WITH AT LEAST 5 YEARS RELEVANT EXPERIENCE (PHARMACEUTICAL, REGULATORY, SAFETY AND PARTNERSHIP)
• EXPERIENCE IN WORKING CROSS-FUNCTIONALLY
• LEADERSHIP SKILLS, INCLUDING PROVEN LEADERSHIP OF PROJECT TEAMS EXPERIENCE
• THOROUGH SCIENTIFIC KNOWLEDGE SUFFICIENT TO UNDERSTAND ALL ASPECTS OF REGULATORY/PHARMACOVIGILANCE AND PARTNERSHIP ISSUES
• THOROUGH KNOWLEDGE OF THE DRUG DEVELOPMENT PROCESS
• GOOD ATTENTION TO DETAIL
• EXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLS
• PROVEN ABILITY TO WORK ACROSS CULTURES

DESIRABLE
• MSC/PhD in scientific discipline
• Knowledge of new and developing regulatory and pharmacovigilance expectations
• Knowledge of existing AstraZeneca external alliances and collaborative projects
• Knowledge of Regulatory operating model and organisation
• Experience of working in a global organisation, preferably within the pharmaceuticals industry, and of the drug development life cycle and commercial aspects of the industry.

 

WHAT ALTEN OFFERS YOU
Every employee is equally valuable in the success of ALTEN! We are driven by making people grow and develop, which is why we offer you the opportunity to work with what you are truly passionate about. At ALTEN, we have a broad range of assignments at most of the leading companies in Sweden in several different sectors, to make it possible for your wishes to come true. We offer both national and international opportunities and together with your coaching manager, you build your career path so you constantly are able to develop and achieve your goals and dreams! As a consultant at ALTEN, you will get the genuine team feeling at your assignment but also a wonderful togetherness at ALTEN. Through our different internal networks, such as ALTEN Sports, Women@ALTEN and ALTEN Innovation you will get the opportunity to drive topics and activities that are close to your heart, together with your colleagues. All activities are of course optional. Work life balance is our top priority. We also have a collective agreement and other benefits like Pension, Insurances and Wellness grants.

We believe in growing together!