All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. As we continue to develop healthcare products and expand our business globally, we are consistently looking for new talents. Right now, we are seeking highly qualified candidates to fill the position:
Regulatory Affairs Manager
Work location: Silverdal, Sollentuna, Sweden
Type of contract: Regular
Recruiting Manager: Cecilia Yhrefors
This is what you can look forward to:
- Creating marketing/strategic plans for assigned products, projects and therapeutic areas aligning business and regulatory needs
- Providing comprehensive regulatory input and support commercial objectives
- Communicating, coordinating, sharing and agreeing goals for regulatory approval and maintenance with Pfizer and above country regulatory strategists
- Providing regulatory input into development projects as well as assist in interpreting the questions/comments from the Medical Products Agency (MPA)
- Being responsible for translations and quality review of translations of concerned parts to supplement the regulatory documentation with regard to the Swedish Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and labeling
- As a Regulatory Manager in Sweden, you would also be responsible for submission and interactions with the Swedish MPA in relation to clinical trial applications and amendments.
What we expect:
- You hold a Pharmacy or other equivalent Life Science degree
- You have at least 3-5 years of experience in Regulatory Affairs (Human Medicinal Products) – proven track record
- You have expert knowledge of local legislation to face new regulatory requirements
- You are native or have bilingual proficiency in Swedish
- Your level of English is professional proficiency
- Strong analytical thinking is one of your major assets
- You are a serious-minded professional who likes to work in teams
In addition to competitive salaries and customized benefits packages, we offer a supportive and diverse culture and unparalleled career development opportunities.
To apply please visit www.pfizer.com/careers and search for JobID: 4731999.
We would like to receive your application, preferably before Jan 31st, 2019.
Please send your CV and cover letter in English.