Tevapharm Helsingborg Sweden
2 months ago
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Teva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we've built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth
What will you do?
As a Regulatory Affairs Associate, y ou will ensure planning, submission of and follow-up... on regulatory applications with the aim of timely approvals, provision of regulatory support for product launches and regulatory life cycle management of the existing portfolio. You will make sure that Teva Sweden follows current regulatory guidelines and will contribute to the identification and implementation of improved processes to secure compliance and to increase efficiency.
Your main responsibilities are:
• Being regulatory responsible for an assigned number of marketing authorizations in Sweden including both new registrations and life cycle management activities
• Act as a point of contact and cooperate with the local health authority in Sweden
• Keeping up to date with the regulatory framework in Europe and Sweden in particular
• Ensuring availability and proofreading of local language product information (SPC, PIL and labelling) in line with current regulations/guidelines and internal processes
• Preparing artworks for regulatory submissions, including making requests, review and finally approve for production in accordance with current regulations/guidelines and internal procedures
• Ensuring a close cooperation with Teva regulatory colleagues in the other Nordic countries in case of common nordic packs
• Acting as the regulatory representative in different cross-functional settings including close cooperation with other local functions such as commercial, portfolio, supply chain, pharmacovigilance and quality affairs
• Contributing to knowledge sharing within the team and continuously improving working processes to maximize efficiency and quality
Who are you?
You have a master´s degree in pharmacy, pharmaceutical sciences or related field and are now looking for your first job within the pharmaceutical industry. You are a curious, positive and driven person who values a team with experienced colleagues to learn from. In this role it is crucial to have a high attention to detail, being well structured and having strong organization skills. Ideally you can interpret, apply and relay regulatory information but still have a flexible mindset and an ability to challenge perspectives. It is required to be fluent in Swedish and English and to have strong communication skills in both languages.
What do we offer?
• Vacation leave according to Swedish Annual Leave Act
• Bonus based on personal and company result
• Wellness contribution
• Fitness hour
• Flexible working conditions with hybrid working policy
Contact person Function
Medical Regulatory Affairs
Assoc Dir Regulatory Affairs, Sweden
Already Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.
Regulatory Affairs Associate Helsingborg jobs
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