- Contribute to dossier strategy and complex product development plans at a compound level, demonstrating autonomy and accountability.
- Lead and supervise dossier authoring activities for early and late-stage projects with limited guidance from the manager.
- Identify areas for business improvement and support the implementation of enhancements under managerial supervision.
- Develop process and business improvements within the functional organization, aligning with other departments as necessary.
- Interface directly with CMC/Tech team members, Regulatory bodies, external service providers, and internal stakeholders with autonomy.
- Manage several complex projects with accelerated or standard priority, challenging the status quo and driving innovative approaches.
- Strong background in Small Molecules, Technical Dossier Writing, Global (FDA, EU, Latin America, China, Russia) Management of Post Approval Changes and Development.
- PhD with Post-doc experience and 8+ years of relevant experience OR University degree with 12+ years of relevant experience.
- Demonstrates behaviors aligned with Sobi's core values: Care, Ambition, Urgency, Ownership, and Partnership.
- Competitive compensation for your work
- Emphasis on work/life balance
- Collaborative and team-oriented environment
- Opportunities for professional growth
- Diversity and Inclusion
- Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments
-
Global Regulatory Affairs Manager
för 6 dagar sedan
Karo Healthcare Stockholm, SverigeKaro Healthcare, a dynamic and growing company, is all about making smart choices for everyday healthcare. With a wide-ranging portfolio across seven categories including medical products, we own and sell over 100 brands in about 90 countries. Our portfolio includes such brands a ...
-
PRA Leader NE Hub
för 1 vecka sedan
Lilly Stockholm, Sverige HeltidWe're looking for people who are determined to make life better for people around the world. · Title: PRA Leader NE Hub · Location: The role can be based in either: Sweden, Norway, Finland or Denmark. · Working pattern: 3 days a week in the office, company travel across the Nordi ...
-
Scientific Evidence Partner, Ophthalmology
för 4 dagar sedan
Roche Solna, Sverige HeltidThe Position · The Scientific Evidence Partner (SEP) has a key role in scientific knowledge and clinical trial execution in the local Roche organization. This is done with high focus on partnering, innovating and implementing sustainable solutions for Healthcare and Roche. By do ...
-
SIPRI seeks a new Deputy Director
för 2 veckor sedan
Stift Sipri Solna, Sverige HeltidThe Stockholm International Peace Research Institute (SIPRI) is an independent international institute, formally a Swedish foundation, whose mission is to undertake research and activities on security, conflict and peace. Established in 1966, SIPRI provides data, analysis and rec ...
-
Value & Access Country Lead Sweden
för 1 vecka sedan
Biogen Upplands Väsby, SverigeJob Description · About This Role: · As the Value & Access Country Lead at Biogen, you will spearhead the optimization of patient access to our current and upcoming products, establishing local market access strategies and tools that harmonize with global and regional strategie ...
-
Value & Access Country Lead Sweden
för 1 vecka sedan
Biogen Upplands Väsby, Sverige HeltidAbout This Role · : As the Value & Access Country Lead at Biogen, you will spearhead the optimization of patient access to our current and upcoming products, establishing local market access strategies and tools that harmonize with global and regional strategies. Your pivotal ro ...
-
Director Process R&D
för 3 dagar sedan
Ardena Södertälje, Sverige permanentAbout us · Ardena is a contract development and manufacturing organization for the pharmaceutical industry. We assist pharmaceutical companies, from virtual biotech to big pharma, in bringing their valued molecule(s) to the clinic and market. We provide a comprehensive and integ ...
CMC Dossier Manager - Stockholm, Sverige - Sobi
Beskrivning
At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.
The CMC Dossier Manager plays a crucial role in developing the technical eCTD sections to support Regulatory CMC dossier applications. They work with limited guidance from the manager and are responsible for coordinating and providing technical oversight for the generation of the CMC dossier for marketing and clinical trial submissions. Additionally, they coordinate timelines, virtual documents, and the generation of the Quality module.
Job Description
Qualifications
All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.
If you are ready to be a part of the Sobi team and contribute to groundbreaking therapies for rare diseases, we encourage you to apply for the CMC Dossier Manager position. Join us in making a meaningful impact on patient lives.
Additional Information
Why Join Us?
Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team:
We are a global company with over 1,700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we're ready to take on the world's diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others' lives because that's exactly what we do here. If you're seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.
We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff. Sobi Culture At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them. As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can't change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.