Technical Regulatory Support Manager

vor 2 Wochen


Basel, Schweiz CTC Resourcing Solutions Vollzeit

**_The Life Science Career Network_**

**Technical Regulatory Support Manager -5446**

Our client is a pioneer in Drug Discovery and Development and one of the frontrunners in Personalised Healthcare. As the world's largest R&D spender in the pharmaceutical and diagnostics domain, they work in a vast number of drug discovery & therapeutic areas and are highly recognized internationally.

We are currently looking for a **Technical Regulatory Support Manager** for **12-month contract **to be based in **Basel, Switzerland.**

**Main Responsibilities**:

- Proactively support the technical regulatory department on the execution of submission-related and administrative activities for global technical registrations
- Effectively manage regulatory changes throughout the product life cycle
- Be responsible for preparation and maintenance of CMC documentation in internal document management systems as well as support associate activities Represent PTR on other cross-functional teams, advise cross-functional teams concerning regulatory requirements and work with diverse partners and personalities
- Ensure regulatory compliance together with local and global technical functions as well as assess technical change records for regulatory impact
- Contribute to excellence by finding opportunities, mitigating risks and supporting continuous improvement
- Contribute to driving efficiency by assertively simplifying, trying new ways and cutting out waste
- Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of the company as well as internal audits and inspections
- Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance
- Monitors and improves tracking/control systems
- Keeps abreast of regulatory procedures and changes
- Direct interaction with regulatory agencies on defined matters

**Qualifications and Experience**:

- **Relevant Swiss working/residency permit or Swiss/EU-Citizenship required**;
- Must have a Bachelor’s degree - preferably in a scientific field; an advanced degree is a plus
- First hands on experiences ideally in technical regulatory affairs, with profound knowledge on national and international regulations and biotechnology
- Ability to manage projects and have excellent communication skills in English, German is a plus
- Ability to work with IT systems and have a high sense of responsibility concerning CMC data management
- Ability to work in interdisciplinary teams, global project teams and with several interfaces



  • Basel, Schweiz GITR Vollzeit

    **EINFÜHRUNG**: As a preferred supplier for Roche in Basel, we are looking for an individual as **Technical Regulatory Support Manager**: with contract for 1 year. The earliest start date is within 2 months. Home Office will be possible for max. 2 days a week. **AUFGABENBESCHREIBUNG**: - Proactively support the technical regulatory department on the...


  • Basel, Schweiz Proclinical Vollzeit

    Proclinical are recruiting for a Regulatory Technical Manager for a pharmaceutical organisation. This role is on a contract basis and is located in Basel. *** **Responsibilities**: - Accountable for preparation and upkeep of CMC documentation in internal document management systems and assist with associate actions. - Handle regulatory changes throughout...


  • Basel, Schweiz LHH Vollzeit

    We have an exclusive mandate for one of our clients in Medical Devices based in Canton of Neuchatel. As a Regulatory Affairs Manager, you will be responsible for: - Support new product development by using in-depth knowledge and understanding of US domestic and international medical device, regulations (including 510k, and International dossiers) - Lead...


  • Basel, Schweiz Ultragenyx Pharmaceutical Vollzeit

    **Why Join Us?** - Be a hero for our rare disease patients_ Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth - so employees can thrive in all areas of their lives, in and outside...


  • Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions Vollzeit

    The Life Science Career NetworkOur client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a world-leading...


  • Basel, Schweiz Manpower Vollzeit

    **Your mission** To strengthen their team, they are looking **for a Quality & Regulatory Affairs Manager (80% - 100%). based in Neuchâtel.** **Tasks are the following**: **Quality Management** - Further development and implementation of quality management - Deputy to the Quality Management Representative - Conduct internal audits as per audit program -...

  • Regulatory Affairs

    vor 3 Wochen


    Basel, Schweiz Straumann Group Vollzeit

    **Job Purpose** Be a member of product development project-teams from the initiation phase, ensure implementation of quality and Regulatory Affairs requirements for Europe, US & Canada, perform product registration in EU, US & Canada. **Main Tasks and Responsibilities** - Support product development process and ensure compliance of deliverables - Compile...

  • Regulatory Affairs

    vor 3 Wochen


    Basel, Schweiz Straumann Group Vollzeit

    **Job Purpose** Be a member of product development project-teams from the initiation phase, ensure implementation of quality and Regulatory Affairs requirements for Europe, US & Canada, perform product registration in EU, US & Canada. **Main Tasks and Responsibilities** - Support product development process and ensure compliance of deliverables - Compile...


  • Basel, Basel-Stadt, Schweiz nemensis ag Vollzeit

    For our client, an international pharmaceutical company in Zurich, we are in search for a Senior Regulatory CMC Manager (f/m/d).Responsibilities: Prepare CMC responses to health authority questions during development, registration and product lifecycle Identify the required documentation for global submissions and negotiate the delivery of approved technical...


  • Basel, Schweiz Philip Morris International Vollzeit

    Manager Scientific Regulatory Strategy - Neuchatel, Switzerland Be a part of a revolutionary change. At PMI, we’ve chosen to do something incredible. We’re totally transforming our business, and building our future on smoke-free products. With huge change, comes huge opportunity. So, wherever you join us, you’ll enjoy the freedom to dream up and...


  • Basel, Basel-Stadt, Schweiz Pharma-Jobs24 Vollzeit

    Would you like to specifically demonstrate your expertise in the field of pharmaceutical services in a new professional challenge in order to fully exploit your potential? Then take the next step with us As a specialised personnel service provider, the bruederlinpartner group brings specialists and managers in the field of pharmaceuticals, research and...


  • Basel, Schweiz Source Group International Vollzeit

    Posted: - Today- Location: - Basel, Switzerland- Job Ref: - BH-34786- Job Type: - Contract- Salary: - CHF40 - CHF44 per hour- Expiry date: - 1/18/2023- Contact: - Audwin Cheung- Xplore Life Sciences are recruiting for an Associate Regulatory Affairs CMC Manager to work for a Global Leader in Pharmaceuticals based in Basel. This is an 18 Month freelance...


  • Basel, Schweiz Manpower Vollzeit

    **For our client, a leading pharma company in Basel, we are looking for a Regulatory Affairs CMC Associate Manager to start asap.** **Your mission** As Associate Manager within our Global Regulatory Affairs CMC team, you support timely preparation of high-quality CMC (Chemistry, Manufacturing, and Control) regulatory documentation for our products and...


  • Basel, Schweiz CPL Recruitment Vollzeit

    **Posted date **15 April 2024 **Location**Basel **Job type** Permanent **Salary**Negotiable **Discipline** Life Sciences **Reference**JO-2404-533260 **Work Location** Hybrid An exciting and growing business looking to bring state-of-the-art medical technology to the market, enabling people globally to self-manage diabetes and other chronic diseases,...

  • Regulatory Affairs

    vor 3 Wochen


    Basel, Basel-Stadt, Schweiz Straumann Vollzeit

    Job PurposeBe a member of product development project-teams from the initiation phase, ensure implementation of quality and Regulatory Affairs requirements for Europe, US & Canada, perform product registration in EU, US & Canada. Main Tasks and ResponsibilitiesSupport product development process and ensure compliance of deliverablesCompile the Regulatory...

  • Regulatory Affairs

    vor 4 Wochen


    Basel, Basel-Stadt, Schweiz Straumann Vollzeit

    Job PurposeBe a member of product development project-teams from the initiation phase, ensure implementation of quality and Regulatory Affairs requirements for Europe, US & Canada, perform product registration in EU, US & Canada. Main Tasks and ResponsibilitiesSupport product development process and ensure compliance of deliverablesCompile the Regulatory...

  • Technical QA Manager

    vor 3 Wochen


    Basel, Schweiz ITech Consult Vollzeit

    **Technical QA Manager** **Technical QA Manager (M/F/d) - GMP / Pharma / Qualification / Validation / CSV** **Projekt**: For our client, a big pharmaceutical company in Basel we are looking for Technical QA Manager (M/F/d). **Background**: **Tasks & Responsibilities**: - Running, maintaining and continuously improving Qualification/Validation activities...


  • Basel, Basel-Stadt, Schweiz Bayer Vollzeit

    At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and...


  • Basel, Basel-Stadt, Schweiz SimplyVision GmbH Vollzeit

    For our customer located in Basel/Switzerland we are currently looking for a:Regulatory Affairs CMC Associate Manager (M/F/x)**- pay rate range - given by our client: 51 chf/h*Hiring Manager Job Description: As Associate Manager within our Global Regulatory Affairs CMC team, you support timely preparation of high quality CMC regulatory documentation for our...


  • Basel, Schweiz Manpower Suisse Vollzeit

    **For our client, a leading pharma company in Basel, we are looking for a Regulatory Affairs CMC Associate Manager to start asap.** **Contract duration**: 18 months with extension possible **Workload**:100% **Location**: Basel city **Description**: As Associate Manager within our Global Regulatory Affairs CMC team, you support timely preparation of...