Regulatory Account and Line Manager, Operations Regulatory

Do you have expertise in, and passion for CMC Regulatory? Would you like to apply your expertise to impact delivery of medicines that patients need in a company that follows the science and turns ideas into life-changing medicines? Then AstraZeneca might be the one for you!



At AstraZeneca we turn ideas into life-changing medicines and strive to continuously meet the unmet needs of patients worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.



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're very proud to enable accelerated and secure delivery of medicines to our patients.



We are now looking for a Regulatory Account and Line Manager to support and lead a team of approximately 10 CMC specialists. The team is responsible for managing post-approval CMC (Chemistry Manufacturing & Control) maintenance activities/projects. The line manager also strategically supports the project portfolio for which the team is accountable.



The highly collaborative team of CMC specialists are dedicated to delivering high-quality CMC Regulatory submissions in a timely manner. As a team, the group is advanced problem-solvers who collaborate with very positive energy and also enjoy each others' company with the occasional lunch and different activities. The Lean concept is part of the team's culture and all team members understand that the job consists of two parts; enable the end-to-end supply chain and AstraZeneca's license to operate and ensure processes and standards are continuously improved and waste removed.



You will report to Head of RITA and play a key role in the leadership team. The position is a permanent position and based in Södertälje, Sweden.



What you'll do

As our Regulatory Account and Line Manager, you will provide operational, tactical and strategic CMC regulatory expertise and direction to product and project teams in support of products throughout the product lifecycle.

You will be representing Operations Regulatory in global cross-functional teams such as the Global Supply Teams (GST). You will also be expected to work closely with other regulatory functions in AZ, as well as the manufacturing sites.

* Line -management and development of a team of professional regulatory staff.
* Strategically plan CMC submissions and provide AZ technical functions clear concise guidance on current regulatory requirements.
* Ensure expert recommendations and decisions relating to CMC for individual products/product portfolios including risk management and mitigation.



Essential requirements

* Degree, or equivalent, in Chemistry or Pharmacy or Chemical Engineering
* Excellent written and verbal Swedish and English
* A minimum of 12 months experience in line management
* A minimum of 12 months experience in Pharmaceutical Production or Quality Assurance or Quality Control or Product Maintenance or Regulatory Affairs



Skills and capabilities / The leader we're looking for

We're looking for you who either is an experienced leader or has extensive knowledge in Regulatory CMC. Preferably a mix of both, but essentially you need to feel very comfortable taking lead in one area to enable space to grow in the other. No matter where your strength lies you need a can do-attitude, seeing opportunity rather than obstacles and possess great interpersonal skills. To be passionate about the team's development is absolutely critical, both on a broader strategic level and for each team members own development. You have excellent communication skills and the ability to make effective decisions despite uncertainty and/or incomplete information to drive business outcomes.



It's a big plus if you have experience or interest in the LEAN concept and understand how this can be adapted to an office-based environment.



Why AstraZeneca? Our offer to you.

When we at AstraZeneca see the chance to change, we take this opportunity - every opportunity, no matter how small, can be the beginning of something big. Delivering medicine that changes people's lives is about having an entrepreneurial spirit - finding moments and understanding its potential.



We are looking for you, who together with your team will make a difference for patients' lives every day. This through your ability to independently lead and motivate your team to achieve set goals within budget, time and to the right quality. AstraZeneca welcomes your positive attitude and your desire to develop both yourself, your team and the department. You will get use for your drive and your ability to work diligently and structured even at a high tempo.



If you're looking for more info on our more tangible benefits, such as vacation days and bonus - look no further, its here --> http://bit.ly/AstraZenecaBenefits



Are you already imagining yourself joining our team in Södertälje? Great, because we can't wait to hear from you.



For more information about the positions please contact: Cecilia Just Davies at +46 709 154549.

Welcome with your application no later than 24th of May 2020. We will review and interview continuously as applications come in, so don't hesitate - apply now!