Global Regulatory Affairs Leader
il y a 4 semaines
Sobi is dedicated to expanding its global reach, and the Global Regulatory Affairs Leader plays a crucial role in our international growth strategy. This position is essential for facilitating the registration of our existing products and developmental projects across various international markets.
Key Responsibilities- Act as the representative for the International region within the Global Regulatory Team and participate in cross-functional discussions for designated products.
- Formulate international regulatory strategies and submission plans in collaboration with the Global Regulatory Lead and local country teams for products under development.
- Design and compile a comprehensive core dossier for international submissions, working alongside cross-functional teams for assigned products.
- Establish regulatory strategies tailored to specific countries, in partnership with local regulatory teams.
- Oversee and coordinate all elements necessary for the successful preparation, submission, and timely approval of marketing applications and post-approval activities in designated countries.
- Provide strategic insights regarding regulations and updates in the assigned regions.
- Facilitate interactions with health authorities in the respective countries.
Educational Background and Experience
- A University Degree in Life Sciences is essential, accompanied by 5 to 7 years of relevant industry experience, including a minimum of 3 years in Regulatory Affairs (covering registration, development, and maintenance).
- Familiarity with regulatory requirements in regions outside the US and Europe is required.
- Proficient in written and spoken English; knowledge of additional languages is advantageous.
- Demonstrated experience in leading projects and managing cross-functional teams.
- A collaborative team player, capable of working effectively within diverse teams and engaging with individuals from various cultural and professional backgrounds.
- Highly self-driven with the ability to initiate and propel activities forward.
- Exceptional communication skills.
- The ideal candidate will embody Sobi's core values: Care for our patients, colleagues, and company; Ambition; Urgency; Ownership; and Partnership.
- Commitment to uphold exemplary behavior, ethics, and transparency within the organization and with regulatory bodies.
At Sobi, we believe in fostering a culture that empowers every individual to make a significant impact in the realm of rare diseases. We are a global organization with a commitment to the communities we serve, and we recognize that our employees are our most valuable asset. Our competitive benefits package is designed to support the well-being and satisfaction of our staff.
Our Culture
We challenge the status quo and strive to find innovative solutions for those affected by rare diseases. As a specialized biopharmaceutical company, our focus on rare diseases is a source of strength, enabling us to transform research into groundbreaking treatments that enhance accessibility for patients.
Equal Opportunity Employer
Sobi is an Equal Opportunity Employer, ensuring that all employment decisions are based on business needs, job requirements, and individual qualifications, without discrimination of any kind.
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