Regulatory Affairs CV: Example and Template
How to structure your CV as a Regulatory Affairs Manager in the Swiss pharma and medtech industry - with concrete approval figures instead of empty phrases.
Currently 53 open Regulatory Affairs Manager positions in Switzerland, across 8 cantons, 11 of them from the last 7 days. Ecolab advertises the most.
CV example — two-page template
This template is editable straight away — or upload your existing CV and it is carried into this layout automatically.
What qualification is expected for Regulatory Affairs in Switzerland?
In most Swiss job postings, a degree in natural sciences is the baseline, with regulatory specialisation gained through a CAS or MAS.
Typical foundational qualifications include pharmacy, biology, chemistry, biotechnology, life sciences or medical technology - as an MSc from an ETH or university, or a BSc from a university of applied sciences such as ZHAW, FHNW or HES-SO. For medical devices, engineering degrees (medical technology, microtechnology) are also accepted. Always state the degree together with the institution and year, because HR professionals in the Basel pharma region distinguish very precisely between ETH, university and university-of-applied-sciences profiles.
You demonstrate specialist depth through recognised Swiss further education: the CAS or Diploma in Drug Regulatory Affairs at the ECPM of the University of Basel, the MAS in Regulatory Affairs, or, for medtech, courses on MDR 2017/745 and ISO 13485. TOPRA and RAPS certifications are also well regarded. List these credentials in a dedicated "Further education and certificates" section with the year, and leave out plain half-day training sessions without an exam.
Without a formal regulatory qualification, you get further by providing concrete procedural evidence instead: the number of Swissmedic dossiers submitted, procedure types under HMV4, variations managed, MDR transitions, or roles in inspections. A sentence like "6 Swissmedic new registrations as procedure lead, 5 without a second deficiency letter" carries more weight than any generic description of competencies.
How do you describe your work experience in a Regulatory CV?
Structure each position by product category, regulatory framework and measurable outcome - not as a list of tasks.
Start each position with a context line: type of company (originator, generics, medtech SME, wholesaler), portfolio size and markets. A sentence like "Portfolio of 62 authorisations in Switzerland, the EU and the UK, 340 employees" immediately conveys the scope of your responsibility. Follow this with three to four bullet points containing figures: dossiers submitted, number of variations per year, turnaround times in days, number of question lists, audit findings.
Use the terminology of your segment precisely. On the pharmaceuticals side, this includes eCTD Modules 1-5, the CH-specific Module 1, procedures with preliminary decision, accelerated approval procedure, Art. 13 procedures, renewals, SmPC and AIPS publication. On the medical device side: MDR 2017/745, Annex II/III, Clinical Evaluation Report, PMS and PMCF plan, ISO 13485, ISO 14971, EUDAMED, UDI, and the role of the CH-REP under MepV. Anyone who uses these terms correctly and sparingly is recognised as a specialist.
Also mention interfaces and governance: collaboration with the Person Technically Responsible, with pharmacovigilance (PSUR, signal management), with quality (change control, CAPA) and with marketing on advertising materials under AWV. If you wish to include salary figures, use realistic ranges - entry-level profiles are often around CHF 85'000 to CHF 100'000, experienced managers CHF 120'000 to CHF 150'000 - and only state figures if the job posting requires them.
How long should the CV be and is a photo needed?
Two pages are standard; a professional photo remains common in Switzerland, but is never mandatory.
Stick to two pages: page one with profile, quick overview, current role and core competencies, page two with further positions, education, certificates and languages. A third page is only justifiable with more than 15 years of experience or a long list of publications and submissions - and even then, it is better handled as a separate appendix titled "Overview of approval projects".
A professional headshot in the top right corner is still common in Switzerland and expected by HR departments, though it is legally optional. In the header, also add your place of residence, permit status (Swiss citizenship, C, B or G permit), phone number in the format 079 000 00 00, and a professional email address. If applying in the Romandie or at an international group, consider whether an English or French version would be more suitable.
Two Swiss particularities round out the dossier: first, many employers expect work references (Arbeitszeugnisse) as an attachment, so your stated months and titles must match them exactly. Second, for regulatory roles, stating your language levels according to the CEFR matters, since drug information is reviewed in German, French and Italian, and correspondence with Swissmedic is conducted bilingually. Save the document as a PDF named "CV_Lastname_Regulatory.pdf".
Where Regulatory Affairs Manager are hired in Switzerland
How the 53 open positions are spread across the cantons.
Figures as a table
| Canton | postings |
|---|---|
| Genf | 10 |
| Zug | 6 |
| Zürich | 6 |
| Basel-Stadt | 3 |
| Solothurn | 1 |
| St. Gallen | 1 |
| Freiburg | 1 |
| Luzern | 1 |
Which languages the postings require
Of 44 postings that state a language — in brackets, those requiring professional level.
Figures as a table
| Language | postings |
|---|---|
| English | 42 (40) |
| French | 13 (10) |
| German | 10 (7) |
| Italian | 1 (0) |
Who hires Regulatory Affairs Manager in Switzerland
Employers with the most open positions. Staffing agencies are excluded.
Figures as a table
| Employer | postings |
|---|---|
| Ecolab | 3 |
| Grant Thornton Switzerland/Liechtenstein | 3 |
| Swissquote | 2 |
| jj | 2 |
| Sanitas Krankenversicherung | 2 |
| Stryker | 2 |
Full-time or part-time?
How the positions are advertised.
Figures as a table
| Workload | postings |
|---|---|
| Vollzeit / plein temps | 35 |
| Teilzeit / partiel | 3 |
| Temporär | 1 |
The CV in full
To read through and reuse.
Nadine Brügger
Regulatory Affairs Manager (MSc Pharmacy, ETH Zurich) - Pharmaceuticals & Medical Devices
Regulatory Affairs Manager with 9 years of experience in new registrations and lifecycle management for pharmaceuticals (Swissmedic, EMA) and Class IIb medical devices (MDR 2017/745). Responsible for 14 Swissmedic procedures under the standard and accelerated procedures, as well as the maintenance of 62 market authorisations in the EU, UK and Switzerland. Interface role between R&D, pharmacovigilance, Qualified Person and marketing, with experience preparing for Swissmedic inspections and Notified Body audits.
What sets me apart
Swissmedic procedures in detail: Knowledge of procedure types under HMV4: standard procedure, procedure with preliminary decision, accelerated approval procedure (BZV) and approval based on foreign authorisation (Art. 13 HMG). 11 of 14 procedures completed without a second deficiency letter.
Dual expertise in pharma and medtech: Managed eCTD dossiers according to ICH-CTD structure and MDR technical documentation in parallel - including the MDR transition of 8 legacy Class IIa/IIb products and Clinical Evaluation Reports under MEDDEV 2.7/1 rev. 4.
Authority and Notified Body communication: Direct negotiation with Swissmedic assessors, Notified Body (Class IIb) and EU rapporteur; handled 23 lists of questions (LoQ) with an average response time of 21 days.
Regulatory intelligence as a steering tool: Built a monthly regulatory intelligence report covering HMV4 revisions, MDR guidances (MDCG) and EU HTA - basis for 3 early variation submissions and avoided supply interruptions.
Key achievements
Accelerated approval in 9 months. New registration of an oncology product via BZV: dossier approved in 9.5 months instead of the planned 14 months, market access 4 months earlier, expected additional revenue of CHF 2'400'000 in the first year.
MDR transition without a certificate gap. Transitioned 8 legacy products (Class IIa/IIb) to MDR 2017/745; all certificates obtained 5 months before the deadline, no market withdrawal, secured annual revenue of CHF 6'800'000.
Variation process redesigned. Introduced standardised templates and a tracking board for Type IA/IB/II variations: reduced turnaround time from 47 to 26 days, handled 118 variations per year with a team of 3.
Experience
Regulatory Affairs Manager — Alpinovis Pharma AG, Basel, 03/2021 - present
Mid-sized generics and specialty pharma company, 340 employees, portfolio of 62 authorisations in Switzerland, the EU and the UK.
- Submitted 6 Swissmedic new registrations as procedure lead, 5 approved without a second deficiency letter (industry average: 2.3 rounds)
- Managed 118 variations per year and reduced the average turnaround time from 47 to 26 days
- Prepared for and accompanied the 2023 Swissmedic inspection: 2 minor observations, no critical deviations, CAPA closed within 45 days
- Trained 2 junior regulatory specialists and brought them to independent eCTD publishing responsibility
Regulatory Affairs Specialist, Medical Devices — Helvetimed Devices GmbH, Solothurn, 08/2018 - 02/2021
Manufacturer of infusion and catheter systems, Class IIa/IIb, 70 percent export share, EU Notified Body.
- Led the MDR transition of 8 legacy products, all certificates obtained 5 months before the deadline
- Revised 24 technical documentation files under Annex II/III MDR, 11 of them with a new Clinical Evaluation Report
- Managed registrations in 12 export markets (including the UK, Australia, Canada), cutting processing time per market by 30 percent
- Passed a Notified Body audit with 3 findings, all closed within 30 days
Regulatory Affairs Associate — Rheinlicht Biosciences AG, Kaiseraugst, 09/2016 - 07/2018
Biotech SME with 90 employees, focused on biosimilars and Phase II/III clinical development projects.
- Prepared Modules 1 and 3 of 4 eCTD dossiers and submitted them via the Swissmedic eGov portal
- Updated 48 SmPCs and patient information leaflets and published them on time in AIPS
- Built a regulatory intelligence report with 100 percent coverage of HMV4 changes for 3 specialist areas
- Coordinated 23 lists of questions, average response time of 21 days (target: 30 days)
Education
MSc, Pharmaceutical Sciences — ETH Zurich · 2016
BSc, Pharmaceutical Sciences — ETH Zurich · 2014
CAS, Regulatory Affairs (Drug Regulatory Affairs) — University of Basel, ECPM · 2019
TOPRA Introduction to European Regulatory Affairs (2020) · MDR 2017/745 Lead Auditor Fundamentals, SQS Zurich (2019) · GMP/GDP Fundamentals Course, Swiss Association of Pharmaceutical Professionals (2018) · eCTD Publishing Advanced, Lorenz Life Sciences (2022)
Common questions
- What language should I write my CV in as a Regulatory Affairs Manager?
- 89% of the adverts are in English — write the CV in English unless the advert itself is in German.
- Where in Switzerland are Regulatory Affairs Manager most in demand?
- Spread out, Geneva first at 19%, then Zug and Zurich. Across a language border, apply with the matching version.
- What language level do Regulatory Affairs Manager adverts ask for?
- English in 95% of adverts that state a requirement, 95% of them at professional level. "Good knowledge" will not do — give A2 to C2.
- Are Regulatory Affairs Manager roles offered full or part time?
- 92% full time, only 8% part time. If you need part time, say so early rather than leaving it open.
- Who hires Regulatory Affairs Manager in Switzerland?
- Currently Ecolab, Grant Thornton Switzerland/Liechtenstein, Swissquote, among others. Their adverts are the best word list for your own CV.