Regulatory Affairs Manager to Mylan
Mylan AB is looking to recruit a driven Regulatory Affairs Manager to strengthen the Regulatory Affairs team. In this role, you will have the opportunity to work cross-functionally with both internal and external collaborators and help drive the company’s visions and goals by the excellent management of regulatory activities for the product portfolio. This means mainly ensuring to maintain and optimize the existing registrations in line with regulatory requirements. Since the acquisition of Meda in 2016, Mylan is now one of the largest pharmaceutical companies on the Swedish market with an exciting journey going forward.
We are looking for someone with a can-do attitude and problem-solving mindset who is looking for an exciting workplace with dedicated colleagues. This is an opportunity to develop in a role with a lot of responsibility. At Mylan you work close with your colleagues in a positive atmosphere.
The position is full-time and based in Bergshamra, Solna. We will interview candidates continuously and welcome your application today!
As Regulatory Affairs Manager at Mylan you will be responsible to ensure regulatory requirements are fulfilled for the Locally Owned Product Portfolio for the Swedish market.
Key duties and responsibilities include:
– Responsible for regulatory activities with main focus on Post Approval Activities, but could also include line extensions, OTC switches.
– Timely coordinate, prepare and submit regulatory applications, renewals, variations, withdrawals in cooperation with other functions.
– Assess, approve, progress and ensure timely implementation of change controls.
– Provide regulatory expertise and advice to manufacturers (internal and external) and recommend the right course of action.
Key qualifications include:
– Relevant scientific background
– >5 years’ experience in the pharmaceutical industry whereof minimum 3 years within Regulatory Affairs
– Fluently in Swedish and English both speaking and in writing
We are looking for a structured and analytical team player with a high sense of responsibility who looks for ways to improve and promote regulatory compliance and thrives in translating regulatory requirements into practical, workable plans. We believe you to be a person with strong dependability, attention to detail and natural ability to prioritize tasks while maintaining a high standard of quality. We are an experienced and dedicated team and we promote a knowledge-sharing environment to ensure that we grow individually and professionally. Therefore, you must have interpersonal skills and enjoy the benefits of effective collaborations and team spirit.
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 unmet 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 7,500 marketed products around the world, including antiretroviral therapies on which more than 40% of people being treated for HIV/AIDS globally depend. We market our products in more than 165 countries and territories. We are one of the world’s largest producers of active pharmaceutical ingredients. Every member of our more than 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com