Do you have experience within Regulatory Affairs and comprehensive knowledge of CMC? Mylan are now looking for a Regulatory Affairs CMC Manager to strengthen their Regulatory CMC team. Mylan are now one of the largest pharmaceutical companies on the Swedish market since the merger with Meda last year.
You will have the opportunity to work in a broad role that includes both internal and external collaborations, operating at a Nordic level. This is your chance to be part of an expanding company and an experienced, dedicated CMC-team.
The position is based in Bergshamra, Stockholm. We will interview candidates continuously so don't hesitate to send in your application.Job description/Key responsibilities
As Regulatory Affairs CMC Manager at Mylan you will be responsible for that regulatory CMC requirements are fulfilled for the Locally Owned Product Portfolio, throughout the Nordic region. You will drive the company's visions and goals by the excellent management of regulatory activities for the product portfolio. The responsibility is also to ensure that new marketing authorizations are approved and maintained and optimize the existing registrations in line with regulatory requirements.
Key duties and responsibilities include:
- Responsible for the fulfillment of regulatory CMC requirements, for new Marketing Authorisation Applications and Post Approval Activities.
- Develop and implement regulatory CMC strategies for new Marketing Authorisation Applications and Post Approval Activities.
- Act as regulatory lead for tech transfer project, i.e. manufacturing transfers.
- Timely coordinate, review and prepare module 2 and 3 CMC documents to support regulatory application, renewal, variations, to relevant markets in cooperation with other functions.
- Assess, approve, progress and ensure timely implementation of change controls.
- The Regulatory CMC Manager is responsible for continuously monitor changes in the external regulatory environment with regards to regulatory CMC aspects (specifically within Europe), e.g. new guidelines, HA trends.
- The Regulatory CMC Manager is point of contact, with regards to regulatory CMC questions, for 3rd party manufacturers.
To qualify for this role, you have a university degree (BSc) in Pharmaceutical or Natural Science or equivalent. You have at least 3 years documented experience from the pharmaceutical industry working within Regulatory CMC and/or pharmaceutical manufacturing process development. Further you have experience of regulatory guidelines and legislation within the CMC area. Recent and broad experience of similar roles within Regulatory Affairs in EU and EEA for pharmaceutical products is a strong merit. In addition, experience from pharmaceutical manufacturing and/or lab work is also a strong merit. You must be fluent in English, both speaking and writing. Fluent Swedish is merit.
To fit the role, you possess the ability to work individually as well as cross-functional in teams with many different functions, e.g. other regulatory functions, QA, strategic purchasing, marketing and 3rd party manufacturers. Strong social and communication skills are required to work effectively in a project organization and team environment and establish/maintain effective working relationships.
Further the right candidate is friendly, has a positive mindset, and is fun to work with.Mylan
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 2700 different products. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 165 countries and territories. The People at Mylan are dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. Changing the world for the better takes skill, passion, drive and you. But don't take our word for it. See for yourself. See inside. mylan.se