Manager Regulatory Affairs
Egetis Therapeutics AB (publ) / Administratörsjobb / Stockholm
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hela Sverige Visa alla jobb hos Egetis Therapeutics AB (publ) i Stockholm Join us in helping patients with rare diseases. At Egetis Therapeutics we challenge the status quo for the benefit of those in need. We offer an open, positive and supportive culture where everyone can be their best. Through trust, we work seamlessly across functions. As an employee you are empowered and encouraged to have an entrepreneurial spirit, enjoying an organization with conscious and efficient decision-making. We also take pride in having a great working climate!
Our vision is to bring unique life-improving therapies to patients with rare diseases. Egetis Therapeutics currently has two drug candidates in late-stage clinical development, and we are continuously seeking opportunities to grow our pipeline. For the lead drug candidate, Egetis submitted a marketing authorization application to the European Medicines Agency (EMA) in October 2023 and intends to submit a new drug application (NDA) in the US in mid 2024 under the Fast-Track Designation granted by FDA. We are now on an exciting journey to establish our own teams for product launches in Europe and North America.
We are committed, courageous, and collaborative people. Become a part of our inspiring environment. We care for the rare!
We have an Office downtown Stockholm where you are welcome to join us for work. However, we are flexible if you prefer to work from home anywhere in Europe or East Coast North America.
As the Regulatory Affairs Manager you will be a member of the regulatory team, as well as representing Regulatory Affairs in cross-functional teams. You will support and lead activities such as planning for health authority interactions and submissions. In addition, you will work closely with the VP regulatory affairs, and team, in overseeing external regulatory vendors. You will lead the regulatory operational aspects and be a part of regulatory compliance and submissions for all projects across the company.
• Responsible for establishing regulatory planning and tracking tools to ensure regulatory submission strategies are delivered in alignment with business needs.
• Responsible for planning and managing regulatory submissions and support interactions with Health Authorities including scientific advisory meetings.
• Coordinate the preparation, submission, responses to requests from regulatory agencies and follow-up contact with regulatory agencies for all applications and submissions.
• Supporting regulatory compliance to be aligned with regulatory requirements and regulations.
• Responsible for providing regulatory support to business development, including management of due diligence activities.
• Support the Regulatory team and cross-functional teams in the global Managed Access Program.
• Monitor changes in the regulatory environment, both general and specific to the therapeutic area and support and advise the Reg Affairs organization and project team accordingly.
• As an Egetis Therapeutics member of the Regulatory Team, contribute to the overall development of the company and value creation.
Your background
Education
• A Bachelor of Science degree or Master of Science (Biology, Pharmacy, Chemistry)
Experience
• Experience from Regulatory Affairs in biotech and pharmaceutical industry, Rare disease drug development program experience is a big plus.
• Experience of HA submissions in early and late development, supporting successful Phase I-III clinical trials submissions including INDs, CTAs (CTIS).
• Global Experience of coordinating marketing authorisation applications is a big plus
• Experience of regulatory management of expanded access programs is a plus.
• Experience of electronic submission requirements and publishing.
Your Skills and Abilities
Skills and Abilities
• Balancing stakeholders; Anticipating and balancing the needs of multiple stakeholders.
• Action oriented; Taking on new opportunities and tough challenges with a sense of urgency.
• Plan and align: Planning and prioritizing work to meet commitments aligned with organizational goals.
• Communicate effectively
• Manage ambiguity; Operating effectively, even when things are not certain or the way forward is not clear.
• Being resilient; Adapting approach and demeanor in real time to match the shifting demands of different situations.
• Ability to foresee long-term consequences of decisions.
Values
Naturally you share our values:
• Courage - We challenge the status quo for the benefit of the patient
• Commitment - We operate with high ethical standards through an efficient organization to deliver top quality results
• Collaboration - Through trust, we work seamlessly across functions and with external partners
Ersättning Enligt överenskommelse
Så ansöker du Sista dag att ansöka är 2024-04-01
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Egetis Therapeutics AB (publ) (org.nr 556706-6724)
Arbetsplats Egetis Therapeutics AB
Jobbnummer 8534926
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