Senior Global Regulatory Affairs Manager - Sweden
- Our company is a leading integrated biopharmaceutical company dedicated to bringing innovative therapies and services to improve the lives of rare disease patients and their families.
- We are now looking to recruit two Global Senior Regulatory Affairs Managers who will be responsible for the regulatory work focused to obtain and maintain marketing authorizations through submissions and communication to/with regulatory authorities, for company Global products.
- The positions can also include work in early development projects.
- The work requires extensive internal as well as external communication and co-ordination.
- Regulatory responsible for product(s) within company Core Products respective Haemophilia
- Contact person in relation to authorities (applications, meetings, etc.)
- Responsible for coordinating and submitting variations and post-marketing obligations to authorities with a main focus on CMC related submissions
- Be an expert on processes, applications, and regulatory environment to achieve and maintain marketing authorizations
- Provide generalist comments on the content of regulatory applications
- Develop global regulatory strategies
- Responsible for the CDS and product information
- Cooperate with authorities, partners, regulatory consultants, and other departments within the company
- Participate in strategic and regulatory evaluations of in-licensing matters
- Develop and update regulatory SOPs
- Provide regulatory input to project forecasts
- Degree in Life Sciences such as Pharmacist, MSc in Chemistry/Engineering/Biomedicine
- Several years of relevant experience from pharmaceutical industry or competent authority
- Extensive knowledge within Regulatory Affairs CMC.
- Experience from biotechnological product development, including early development is a strong merit.
- Communication skills, both verbal and written in Swedish and English
- Our values (CARE, Collaboration, Accountability, Respect, and Engagement) is the base for our daily work.
- You have analytical & strategical skills, innovative thinking, and bring stability.
- You are a “doer” who take initiatives, get things done and take responsibility for the result.
- Further, you are communicating efficiently.
- Your professional style should be a strong team-player with collaborative, respectful and flexible attitude, and high engagement
Appointment will take place with consideration of:
- Requirements of the role as it is currently framed as well as an assessment of how the post will develop;
- The competences, experience, personal qualities, and motivators of the candidates;
- The wish for our company to secure a well-functioning group with good team dynamics, able to be successful in an international, multi-cultural and cross-border business;
- A wish for all company employees to embrace and align with the company’s CARE values in their day-to-day operations.