Regulatory Information Manager

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. AstraZeneca is proud to offer a unique workplace culture that inspires innovation and collaboration. Co-workers are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.

THE ARENA:
Global Regulatory Operations (GRO) manages several parts of Regulatory Information Management (RIM) within AstraZeneca. GRO has the expertise and provide the tools and services to be able to meet:

• The ever-increasing complexity of regulations and product portfolios
• Growing demand for data due to increased public and regulatory scrutiny
• Global collaboration and standardization of formats and processes across the markets
• Increased use of partners and outsourcing


THE ROLE:
THE MANAGER, REGULATORY INFORMATION IS PRIMARILY RESPONSIBLE FOR SUPPORTING THE MANAGEMENT, COLLECTION, CODING AND ANALYSIS OF ASTRAZENECA REGULATORY INFORMATION, THE GLOBAL PRODUCT REGISTRATION LIST AND REGULATORY DATA STANDARDS SUCH AS XEVMPD AND IDMP.

TYPICAL ACCOUNTABILITIES:
• MANAGES THE COLLECTION, CODING AND ANALYSES OF REGULATORY INFORMATION FOR ASSIGNED PRODUCTS IN ACCORDANCE WITH REGULATORY DATA STANDARDS, QUALITY CONTROL AND QUALITY IMPROVEMENT METHODOLOGIES.
• COMPILES AND DELIVERS XEVMPD OR OTHER REGULATORY INFORMATION-BASED SUBMISSIONS TO HEALTH AUTHORITIES.
• DEVELOPS SELF IN TOPIC AREAS CRITICAL TO SUCCESSFUL DELIVERY OF THE RI REMIT. PARTICULARLY, TECHNICAL SKILLS (XEVMPD, IDMP), KNOWLEDGE OF INTERNATIONAL REGULATIONS AND SKILLS (COMMUNICATION, PROJECT MANAGEMENT).
• ENGAGES WITH PARTNERS, AFFILIATES, SUBSIDIARIES OR OTHER STAKEHOLDERS TO COLLECT REGULATORY INFORMATION AND TO ENSURE COMPLIANCE WITH PROCEDURES AND STANDARDS.
• MONITORS THE ENVIRONMENT FOR CHANGES IN LEGISLATION RELATED TO REGULATORY INFORMATION.
• REVIEWS AND EVALUATES REGULATIONS, GUIDELINES AND TECHNICAL SPECIFICATIONS RELATED TO REGULATORY INFORMATION PROCESSES AND REGULATORY INFORMATION DATA STANDARDS.
• IDENTIFIES OPPORTUNITIES FOR CONTINUOUS IMPROVEMENT.
• PREPARES BUSINESS REPORTS OR ALERTS IN RESPONSE TO BUSINESS OR HEALTH AUTHORITY REQUEST.
• ENSURES COLLECTION AND CODING OF REGULATORY INFORMATION IS DONE IN COMPLIANCE WITH REGULATORY AND PHARMACOVIGILANCE LEGISLATION, REGULATORY PROCESSES AND REGULATORY DATA STANDARDS.

MINIMUM REQUIREMENTS
• University degree in the life sciences or IT
• Experience in pharmaceutical/medical industry
• Knowledge of pharmaceutical drug development process• Strong analytical and critical thinking ability
• Good understanding of current regulatory legislation, guidelines and trends relating to regulatory information (process, tools, standards)
• Able to manage productivity responsibilities

PREFERRED EXPERIENCE AND KEY FACTORS
• GOOD PROBLEM AND CONFLICT RESOLUTION SKILLS
• ABILITY TO SET AND MANAGE PRIORITIES, PERFORMANCE TARGETS AND PROJECT INITIATIVES
• ABILITY TO INNOVATE BEST PRACTICES WITH BUSINESS PROCESS ANALYSIS AND DESIGN
• ABILITY TO THRIVE IN A RAPID PACED ENVIRONMENT

WHAT WE OFFER 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.