Regulatory CMC Associate

Operations Regulatory is a global function that manages all Chemistry, Manufacturing and Controls (CMC) post-approval regulatory activities across AstraZeneca’s global supply chain. We are looking for Regulatory CMC Associates to our product teams located in Södertälje.

We are curious, creative, and open to new ideas and ways of working. Above all, we are passionate about science and driven to always put patients first. Join us and be part of an extraordinary place to work; an environment that energizes and empowers each of us to support compliant product supply through partnership with other AZ teams.


THE ROLE
As a Regulatory CMC Associate you will generate CMC documentation to support lifecycle submissions and keep business wide electronic systems up to date to maintain regulatory status up to approval of CMC documentation supplied by Operations to Global Regulatory Affairs.

You will work with colleagues and other functions within AstraZeneca to obtain information that supports the generation of regulatory CMC documentation.

You may also support externalisation projects and transfer of CMC documentation to external partners.

MINIMUM REQUIREMENTS - EDUCATION AND EXPERIENCE

- Degree in Chemistry or Pharmacy or Chemical Engineering
- Fluently spoken and written English and Swedish
- Experience in Post Approval Regulatory CMC including CMC documentation authoring
- Experience in Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance or Regulatory Affairs

SKILLS AND CAPABILITIES
- Able to work collaboratively with customers and colleagues to achieve optimum outcomes
- Knowledge of information and document management technology
- IT software skills
- Ability to work with short and / or changing timelines
- Attention to details, highly organized, able to plan and control own workload effectively and manage expectation of others
- Excellent written and verbal communication skills
- Experience from using Document Management systems

WHAT WE OFFER YOU AT ALTEN
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!