Regulatory CMC Managers

Regulatory CMC Manager
Regulatory CMC Managers

On behalf of AstraZeneca we are looking for candidates for a consultant assignment within Regulatory Affairs. During this assignment you will have the position as Regulatory CMC manager and be placed at AstraZeneca.

About AstraZeneca:

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we are more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration.

CMC Regulatory Compliance & Stability is a global function that manages all Chemistry, Manufacturing and Controls (CMC) post-approval regulatory activities across the global supply chain.



The role:



The role of Regulatory CMC Manager is focused on Post Approval Regulatory Chemistry, Manufacturing and Control (CMC) strategy and delivery within our CMC Regulatory Compliance Department.



Main Purpose of the role:

To produce and manage the production of CMC documentation for designated commercial products at various stages of product life-cycle, in the required format and to the agreed timetable. To ensure that key stakeholders are kept informed of relevant timelines and regulatory commitments for those products. To work as a partner within relevant product and project teams providing regulatory intelligence and advice, and strategic input, as appropriate

This role will be based in Södertälje, Sweden.



Accountabilities/Responsibilities:



• The Regulatory CMC Manager provides CMC regulatory and compliance advice on regulatory post-approval submissions and project manages timely submissions of post approval CMC documentation.

• As a Regulatory CMC Manager you will generate CMC documentation to support lifecycle submissions and keep business wide electronic systems up to date to maintain regulatory status.

• As Regulatory CMC Manager you will be expected to use your regulatory knowledge to deliver to high standards, influence others and ensure the application of global CMC regulations and guidance.

• The role offers opportunities to work with global networks.



Minimum Requirements - Education and Experience



Essential requirements:



• Degree, or equivalent, in Chemistry or Pharmacy or Chemical Engineering

• Considerable experience in the Pharmaceutical industry, for example Pharmaceutical Production or Regulatory Affairs or Quality Assurance and R&D.

• Fluently spoken and written English and Swedish

• Project Management skills

• Excellent written and verbal communication skills

• Experience of working within a global environment.

• Team working skills, Flexibility, Adaptability, Influencing, Initiative

• Previous experience of working in a Regulatory CMC environment.



Preferable requirements:

• Experience of working with international markets.

• Experience of working in a LEAN environment.

• IT skills and/or knowledge of information and document management technology and electronic/paper publishing software

Business: Dfind Science & Engineering

City: Södertälje

Job type: Full time

Deadline for applications: 2017-01-24

More information: Sofie Önnestam, sofie.onnestam@dfind.se or Julia Gonzales, julia.gonzales@dfind.se



Please send your application in English. We encourage you to send your application as soon as possible, since interviews and candidate selection are done continuously! We put great emphasis on personal suitability for this role.



Organization/Business description: Dfind Science & Engineering is part of Randstad, a global specialists within staffing, recruitment and outplacement. Dfind Science & Engineering is specialized in recruitment and consulting providing competences within Life Science, Science and Engineering and is a company where people make all the difference. At Dfind Science & Engineering specialists are recruiting specialists!



All our recruitment consultants , consultants and sourcing managers have a technical or scientific background, combined with extensive networks within relevant communities and expertise within recruitment and HR. We understand our customers specific requirements and know how to find the best candidates. Through our passionate commitment and high degree of attentiveness we help people and businesses to grow and be competitive in a changing world.