Regulatory Compliance Lead

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you’ve got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

**Your role**:
As the Site Regulatory Compliance Lead, you will play a pivotal role in ensuring regulatory adherence within our multidisciplinary projects, including product launches and technical changes. Acting as the core regulatory contact, you will collaborate closely with internal departments. Your responsibilities will encompass evaluating site change controls, ensuring timely communication with the Swiss Authority, and managing the submission of regulatory documentation. This role is essential in fostering compliance and facilitating effective communication across various regulatory landscapes.

**Key Responsibilities**:

- Act as a core site regulatory contact point in multidisciplinary projects, including launches and technical changes, interacting with internal department (MSAT,

Production, QA, QC, Engineering & Maintenance).
- Review and provide reportability evaluation of site change controls (CCPs), liaising with Global Regulatory Affairs CMC for reportable CCPs.
- Determine reportability and ensure timely communication of changes to Swiss Authority according to Article 41.
- Ensure adequate communication of Manufacturing Changes in Annual Reports and
- Development Safety Update Reports.
- Track and review amendments/commitments and regulatory assessments of CCPs and Supplier Change Notifications related to site products.
- Coordinate and provide support for the writing registration dossiers, organize local reviews for accuracy and ensure coordination with Global Regulatory Affairs CMC.
- Manage deadlines and ensure regulatory submissions are delivered within established timelines.
- Provide/review data or responses to questions received from health authorities.
- Implement follow-up measures and commitments according to the updated plan.
- Establish and provide appropriate documentation to local RA affiliates during initial submission, product license renewal processes and regular compliance check.
- Assess and determine the potential restrictions applicable to the site drug substance batches in the frame of the product disposition.
- Point of contact for HA/affiliates when regulatory statements are required.
- Act as back-up of QA System & Regulatory Senior Manager

**Your role in Inspection Readiness**
- Actively participate in the preparation for inspections/audits, in accordance with the inspection readiness system.
- Participate in external inspections/audits as a Facilitator, Coordinator, or Dry-runner.

**Your role in Internal Audits**
- Conduct assigned audits as lead auditor in compliance with internal procedures and standards, and write corresponding audit reports, classifying observations according to internal procedures within the specified timelines and ensure the adequacy of the CAPA Plan.

**Your role in Corporate and Continuous Improvement Projects**
- Participate in projects as a Team Member.
- Represent the Quality Systems group in global projects with Global Healthcare Quality: participation in working groups, Communities of Practice, and collaborative networks.
- Lead projects within the area of expertise.

**Who you are**:

- Degree in Pharmacy or Life Science, Biotech, Medical, PharmD or related discipline (minimum M. Pharm or MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)
- Minimum of 7+ years of experience in Regulatory Affairs, focusing on medicines (new, generic, similar, and biological)
- Fluent in English and French
- Analytical, strategic, and conceptual thinking.
- Influential, proactive profile with strong interpersonal relationship skills.
- Experience with regulatory systems such as Veeva Vault.

**What we offer**: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creatin