Job Title: Regional Regulatory Lead
Department: Research Development & Sciences
Location: Bern, Switzerland
Desired Start Date: 14/10/2024
Duration: 12 Months

Job Description:
We are seeking a dedicated and experienced Regional Regulatory Lead to oversee our assigned product portfolio in the therapeutic areas of Immunology, Respiratory, and Transplant. In this role, you will align regulatory activities with both regional and global strategies, ensuring compliance with local regulations. Key responsibilities include:

• Leading regulatory activities for the assigned product portfolio across various countries.
• Ensuring that regulatory dossiers meet both regional and local content and format requirements.
• Coordinating, compiling, and tracking high-quality documentation for submissions, including new license applications and lifecycle activities.
• Addressing inquiries related to regulatory submissions to enhance connectivity and improve approval timelines.
• Building and maintaining strong relationships with regional regulatory agencies, employing negotiation and influencing skills for positive outcomes.
• Collaborating with internal functions such as Commercial, Manufacturing, Supply Chain, and Medical Affairs to strengthen connectivity.
• Staying informed about international legislation and guidelines concerning biological products, including initiatives related to rare diseases and orphan drugs.

Qualifications & Experience:

• A degree in Life Sciences is required; a post-graduate qualification or a degree in Drug Regulatory Affairs is advantageous.
• At least 3 years of regulatory experience within the international region, complemented by additional pharmaceutical or industry experience.
• A solid understanding of scientific principles and technical requirements relevant to the development of pharmaceutical products, as well as the principles of GMP and GCP.
• Proficiency in standard regulatory tools, including Veeva, DocNet, and Trackwise.
• Willingness to attend the office at least 20% of the time.

Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. A diverse staff allows us to effectively draw on different perspectives and enhance our efficiency and effectiveness. Diversity thereby strengthens the legitimacy and relevance of Advanced Clinical in delivering services to our clients. We seek talented, creative individuals from a variety of backgrounds and cultures to work with us. It is our priority that our workplace be inclusive, welcoming of diverse ideas and appreciative of valuable experience.
Equal Employment Opportunity
It is Advanced Clinical’s practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.