Quality & Regulatory Associate, Challenging Global Role, Basel

Vor 2 Tagen


Basel, Schweiz Stratpharma AG Vollzeit

An ambitious forward thinking Dermatology company based in the centre of Basel have created an exciting hybrid QARA Associate opportunity that will work closely with the International QARA Director in managing the company’s global QA and RA functions.

This is a highly successful company who have an impressive 200% year on year growth and are going through significant expansion. They currently have 8 products on the market but have a further 5 more products in development, one of which will be released early next year.

Tasks:

Creation, compliance and/or implementation of SOP, Work Instructions, Non-Conformities, Change Control, CAPA, Artworks, and all related document and tasks. Maintain and update all the documents in the companies system. Provide support for Internal and External Audit. Initiate and review regulatory documents ( Technical file) giving support to the Regulatory Manager with the transition from MDD to MDR. Coordinate worldwide registration and compile regulatory submissions, including required legalization activities. Liaise with local agents and distributors to support them in their registration process. Maintain regulatory records and regulatory database.

Requirements

3 plus year’s experience in a similar role. Strong knowledge of regulatory regulations and Quality Systems including knowledge of ISO13485, MDD, MDR and MDSAP requirements in link with QMS activities. Experience of the Medical Device or Pharmaceutical industry. Proactive self-starter who can work autonomously. Strong communication skills with the ability to liaise effectively with stakeholders, suppliers and distributors. Fluent in written and spoken English essential, Spanish an advantage.

Benefits



  • Basel, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Quality & Regulatory Associate, Challenging Global Role, Basel, BaselClient:Stratpharma AGLocation:BaselJob Category:OtherJob Reference:0c55b89f5fc4Job Views:11Posted:21.01.2025Expiry Date:07.03.2025Job Description:An ambitious forward-thinking Dermatology company based in the centre of Basel has created an exciting...


  • Basel, Schweiz Moderna Vollzeit

    The Role Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide,...


  • Basel, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Proclinical is seeking a Quality Assurance Manager to join our client's team in Basel, Switzerland. This role focuses on ensuring compliance with regulatory requirements and best practices within the cardiovascular pharmaceuticals industry. You will play a key role in quality management, supporting both local and...


  • Basel, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Associate Director Regulatory Affairs Biosimilars, BaselClient:AbbottLocation:BaselJob Category:OtherJob Reference:aa318de1e00bJob Views:9Posted:21.01.2025Expiry Date:07.03.2025Job Description:Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing...


  • Basel, Schweiz Global Personal Partner Vollzeit

    **EINFÜHRUNG**: Our profession and our passion "HR Management." Global Personal is an independent company of the Interiman Group SA with over 100 employees offering a complete range of human resources services at 21 locations in German-speaking Switzerland. For our client, an international orientated Pharma company in Basel, we are looking for a reliable...


  • Basel, Schweiz Stratpharma AG Vollzeit

    Stratpharma, a fast-growing Dermatology company, is currently looking for a Global Regulatory Affairs Associate to join their dynamic team. This is an exciting opportunity to be part of a company that is experiencing rapid growth and expanding globally.This is a highly successful company who have an impressive 200% year on year growth and are going through...


  • Basel, Schweiz BeiGene Vollzeit

    REGULATORY AFFAIRS Associate Director, Europe (with focus on Switzerland) Regulatory Affairs, Basel, Switzerland Reports To: Director, Team Lead of EU Regulatory Affairs **Job Description**: The (Swiss) Regulatory Affairs lead will report to the team lead of Regulatory Affairs Europe and will have dotted line reporting to the Swiss General Manager. The...


  • Basel, Schweiz NonStop Consulting Vollzeit

    We are currently partnered with a pharmaceutical powerhouse in Basel, who are looking to extend their workforce with an Drug Regulatory Affairs Manager on a contract basis for at least 6 months, with 40 hours a week guaranteed from the client. They are one of the top 3 companies in the world, with a strong history of extending these contracts, giving you...


  • Basel, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Associate Director, Quality Assurance and Compliance, BaselClient: VeristatLocation: BaselJob Category: OtherJob Reference: d9f621730bc2Job Views: 8Posted: 21.01.2025Expiry Date: 07.03.2025Job Description:Associate Director Quality Assurance and ComplianceThe Associate Director, Quality Assurance and Compliance...


  • Basel, Schweiz BeiGene, Ltd. Vollzeit

    Associate Director, R&D Quality Systems, Strategy, and Excellence (International & Affiliate) BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share...


  • Basel, Schweiz Proclinical Vollzeit

    Proclinical are recruiting an Associate Director Quality Assurance, RP for a biotech corporation. This role is on a permanent basis and is located in Basel. The client is focused on creating, producing and commercialising transformative medicines for those who are suffering from serious illnesses. **Responsibilities**: - Handle local recall actions and...


  • Basel, Schweiz Proclinical Staffing Vollzeit

    Direct message the job poster from Proclinical StaffingSenior Research Associate @ Proclinical StaffingProclinical is seeking a Quality Assurance Manager to join our client's team in Basel, Switzerland. This role focuses on ensuring compliance with regulatory requirements and best practices within the cardiovascular pharmaceuticals industry. You will play a...


  • Basel, Schweiz Lonza Vollzeit

    Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...


  • Basel, Schweiz Abbott Laboratories Vollzeit

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.Abbott...


  • Basel, Schweiz BeiGene Vollzeit

    BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description:   The Associate Director...


  • Basel, Schweiz Sandoz Vollzeit

    **Regulatory Affairs Manager, Novartis, Basel, Switzerland** 1 unique opportunity to join Regulatory Affairs Team! Person on this position will take care of all drug regulatory affairs matters regarding the assigned indication group. Acts as an interface between global Regulatory Affairs departments and Swiss medic in order to obtain new marketing...


  • Basel, 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...


  • Basel, Schweiz VECTURA FERTIN PHARMA Vollzeit

    Contract Type: Permanent Closing date: Reference: VN1710 - Who we are - Vectura Fertin Pharma’s ambition is to become a market-leading wellness and healthcare business. Formed in March 2022, the business brings together two unique organizations: Vectura, experts in inhalation technology and Fertin Pharma, experts in oral and intra-oral delivery systems. -...


  • Basel, Basel-Stadt, Schweiz gloor&lang AG Vollzeit

    Global Quality Leader - CMO ManagementAt our company, we are committed to delivering high-quality products that meet the needs of our customers. As a senior member of our Global QA Team, you will play a critical role in ensuring the quality of our products. Key responsibilities include: * Developing and implementing quality-related policies and procedures*...


  • Basel, Schweiz Universal-Job Vollzeit

    In this role you work with leading regulatory professionals around the world to provide strategic and operational regulatory direction and ensure the execution of regulatory plans in line with global regulatory strategy. You are responsible for integrating global strategy into regional submissions worldwide. You develop and implement plans for timely...