Global Regulatory Lead

Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients. Idorsia is listed on the SIX Swiss Exchange (ticker symbol: IDIA).

Join a role where you’ll work in an international regulatory environment and support the development and lifecycle management of medicinal products across multiple markets.

As Global Regulatory Lead, you will contribute to the development and execution of regulatory strategies in Europe and other regions. You’ll also represent Global Regulatory Affairs for assigned products in cross-functional and governance forums, collaborating with key stakeholders across labeling, safety, commercial, and affiliate teams to help ensure aligned and effective decision-making.

Candidate Requirements

• Master's Degree in life sciences
• At least 5 years of regulatory experience or other job relevant drug development experience, including:
  • Leading/delivering global and/or regional filings
  • Reviews and approvals of major submissions to Health Authorities (HAs)
  • Leading HA interactions
• In-depth knowledge of regulatory legislation and guidelines (ICH, US and EU) and good understanding of other regions
• Strong understanding of the regulatory aspects at various stages of development, from entry-into-man to post-approval activities over full lifecycle of products
• In-depth experience working, communicating and negotiating with the HAs, including coordinating and managing HA meetings
• Strong scientific competence and familiarity with clinical trial methodology and statistics
• Proven development experience
• Proven experience as successful leader in strategic cross-functional environment and matrix environment
• Excellent communication, interpersonal, negotiation and problem-solving skills
• Very good understanding of interrelationships between functions, departments and business priorities
• Effective team player, with experience working in cross-functional and global teams, but also able to work independently
• Ability to work within tight timelines with excellent project management skills
• Excellent spoken and written English

Job Responsibilities:

Regulatory Management:

• Define and provide optimal global regulatory strategies to support the development and approval of new compounds as well as product life cycle management activities for assigned product(s)
• Review critically all global promotional material prior to country-specific review
• Lead creation, review, finalization and maintenance of CCDS for assigned products including communication of changes (with supporting documentation) to affiliates or partners for implementation
• Ensure communication and regulatory support for other countries in collaboration with affiliate or partner and regulatory operations, as needed

Regulatory Leadership:

• Lead the global submission planning process, creation, review and finalization of key regulatory documents intended for submission to HAs
• Represents GRA for assigned product(s) at LCT, management committees and governance related meetings e.g., Global Labeling Committee, Drug Safety and Document Committees, Commercial and Affiliate Leadership Team Collaborate closely with the US Regulatory Lead for regulatory considerations, strategy and key regulatory documents
• Provide consolidated interpretation of relevant HA regulatory guidelines for the development and approval of new drugs as well as product life cycle management
• Ensure compliance with relevant regulatory guidelines and processes worldwide and represents GRA (project-related) at audits and inspections
• Ensure that RA project milestones are achieved

What we offer

• Development – opportunities to grow, learn, and expand your expertise in a dynamic and international organization
• A collaborative culture – a supportive, solution-oriented environment where teamwork, initiative, and new ideas are encouraged
• International exposure – work in a truly multicultural setting with colleagues and partners from around the world

• Work Location: Allschwil
• Country: Switzerland
• Business Area: Global Regulatory Affairs
• Schedule: Fulltime
• Job Type: Permanent
• Job ID: 4721

At Idorsia, we harness the power of difference, authenticity, and inclusion to achieve business success.
We encourage all potential candidates with diverse backgrounds of race, color, religion, sexual orientation, gender identity, age, national origin, and disability to submit their job applications. All applicants will receive consideration.
We are committed to fostering respect, fairness, and equal opportunities for all job applicants and our employees.

Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course.

Idorsia Pharmaceuticals Ltd ("Idorsia") is committed to a fair and transparent application process. In order to avoid any conflict of interest in line with Idorsia Code of Business Conduct, which would undermine such a commitment, the applicants  must disclose any personal, financial, or other outside interests interfering with the interests of Idorsia. Further, the applicant is obliged to disclose any and all relationships with close or affiliated persons, who are employees of Idorsia or are collaborating with Idorsia in any other contractual relationship. 

Please note Idorsia operates a strictly controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia, all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates, or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.