Role & Function
The CMC Dossier Manager is responsible, with limited guidance from the manager, for developing the technical eCTD sections to support Regulatory CMC dossier applications. With limited guidance from the manager, coordinates and provides technical oversight for the generation of the CMC dossier of marketing and clinical trial submissions. Coordinates the timeline, virtual document and the generation of the Quality module. Assumes personal ownership and accountability for business results and solutions working with limited supervision from the manager. Represents the department on multi-functional project development teams to support regulatory filings. Has expertise in appropriate CMC regulatory applications.
Authors/drives, as appropriate, sections of the CMC dossier and evaluates/ensures that final versions comply with regulatory requirements and fulfill regulatory agency expectations with limited guidance from the manager. The CMC Dossier Manager supports the technical functions in the development of responses to health authority inquiries in support of clinical trials as well as major applications with limited guidance from the manager. Evaluates and ensures the completeness, accuracy and compliance of data provided for all regulatory submissions with limited guidance from the manager. Ensures all Quality submissions are completed in a timely manner.
Key Responsibilities
-
Contributes to dossier strategy/complex product development plan creation at a compound level and to limited degree at a functional level
-
Communicates and executes dossier strategy/product development plan with high level of autonomy and accountability
-
Leads and supervises dossier authoring activities for early and late stage projects with limited or no guidance from manager
-
Identifies business improvement areas and helps, under regular supervision of the manager, drive implementation of improvements
-
Develops process and business improvements within own functional organization, and aligns with other departments as needed, with managerial support.
-
With limited or no guidance, interfaces directly with CMC/Tech team members, Regulatory, external service providers and internal stakeholders.
-
Interfaces with internal and external functional stakeholders
-
Influences or persuades others to accept new ideas, approaches or concepts or gains alignment on divergent issues with limited guidance.
-
Combines technical expertise with team working skills. Coaches/mentors others on a regular basis.
-
Manages several complex projects with potentially accelerated or standard priority OR leads complex programs.
-
Challenges status quo and has ability to assist in identifying innovative approaches to improve products/processes
-
Scope is a mix of incremental and transformational innovation, within own dept/team.
-
Independently resolves isolated cross-functional issues.
-
With regular guidance, appropriately identifies and manages key stakeholders, and escalates when needed to obtain senior management support
-
Works independently on a day to day basis, checks in with supervisor as needed for identified high-priority issues
-
Acts as a mentor to one or more individuals
-
May coach project teams.
Qualifications
-
Strong background in Gene therapies, Technical Dossier Writing and Development
-
PhD with Post-doc experience with 8+ years relevant experience
-
OR University degree with 12+ years relevant experience
-
OR equivalent by experience
Personal attributes
In addition, you must demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.
Location
Basel, Switzerland or Europe in general
Reporting to
Head of CMC Dossier Management
Recruitment contact & how to apply
For questions contact HR responsible for this recruitment [email protected] If you are interested in applying for this position, please submit your CV and cover letter through the apply button above.
Sobi is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, or national origin. Sobi is committed to providing access, equal opportunity and reasonable accommodation for individuals with disabilities in employment, its services, programs and activities
If you are interested in being considered for this role, then please attach an updated copy of your resume (as a MS-Word or PDF file) while submitting your application.
Why Join Us?
We are a global company with around 1,500 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.
An Equal Opportunity Employer
Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate.
GUwbE7nH3V
