Drug Regulatory Manager

vor 2 Wochen

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 more security within the role, whilst gaining exposure that in globally recognised within the industry.

**Job Purpose**:
Takes care of all drug regulatory affairs matters regarding the assigned indication group. Acts as an interface between global Regulatory Affairs departments and Swissmedic in order to obtain new marketing authorizations, support new product launches and ensure regulatory compliance.

**Major Accountabilities**:
Preparation of the regulatory strategy for new submissions
Timely submission of new products to Swissmedic in agreement with the yearly target
Obtain a number of marketing authorizations in accordance with the yearly target
Life cycle management. Submit maintenance variation packages to ensure regulatory compliance.
Provide close regulatory support to the product launch work stream
Strategic business partner to Business Development, Quality Assurance, Supply Chain as well as for other Global Regulatory Groups (RCCs, MRCs)
Follow trends in the regulatory environment and legislation and assure awareness and alignment within the department, in order to meet future requirements on time
Always work in accordance with Good Regulatory Practice

**Education**:
Pharmacist or natural scientist preferably with medical background

**Languages**:
German (fluent), English (intermediate to advanced) and French (desirable)
NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.

  • Regulatory Affairs CMC Manager, Drug Substance

    Vor 4 Tagen

    Basel, Schweiz Trades Workforce Solutions Vollzeit

    Regulatory Affairs CMC Manager (Drug Substance – ADC focus) – Basel, Switzerland 📍 4 days on site / 1 day remote💶 Salary range: 105K–120K CHF Responsibilities: Lead Drug Substance (DS) CMC regulatory activities, focusing on antibody–drug conjugates (ADCs), chemical payloads, and bioconjugates. Author and review clinical regulatory submissions...

  • Drug Regulatory Affairs Manager

    Vor 6 Tagen

    Basel, Schweiz NonStop Consulting Vollzeit

    My client is offering an amazing opportunity to work on site in Basel for 18 months as a Drug Regulatory Affairs Manager. During your time in this role you will also have the opportunity of growth and promotion giving you the possibility of earning even more money over the period of the contract. If this sounds like it is something for you click below and...

  • Regulatory Affairs CMC Manager, Drug Substance, ADC

    vor 1 Woche

    Basel, Schweiz Barrington James Vollzeit

    OverviewJoin to apply for the Regulatory Affairs CMC Manager, Drug Substance, ADC role at Barrington James.Must be based/willing to travel to Basel, Switzerland4 days on site / 1 day remoteSalary range: 105K–120K CHFResponsibilitiesLead Drug Substance (DS) CMC regulatory activities, focusing on antibody–drug conjugates (ADCs), chemical payloads, and...

  • Basel CMC Regulatory Manager – ADC Drug Substance

    Vor 4 Tagen

    Basel, Schweiz Trades Workforce Solutions Vollzeit

    A leading workforce solutions provider is seeking a Regulatory Affairs CMC Manager for a role focused on drug substance, particularly antibody-drug conjugates (ADCs). The successful candidate will lead CMC regulatory activities, author submissions, and collaborate with external partners in Basel, Switzerland. A strong background in CMC processes and solid...

  • Regulatory Affairs CMC Manager, Drug Substance, ADC

    vor 2 Wochen

    Basel, Schweiz Barrington James Limited Vollzeit

    Must be based/willing to travel to Basel, Switzerland4 days on site / 1 day remote Salary range: 105K–120K CHF Responsibilities: Lead Drug Substance (DS) CMC regulatory activities, focusing on antibody–drug conjugates (ADCs), chemical payloads, and bioconjugates. Author and review clinical regulatory submissions from scratch (IMPD/IND, CTD Modules 2 &...

  • Regulatory Affairs CMC Manager, Drug Substance, ADC

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Barrington James Vollzeit CHF 105'000 - CHF 120'000 pro Jahr

    **Must be based/willing to travel to Basel, Switzerland4 days on site / 1 day remote**Salary range: 105K–120K CHFResponsibilitiesLead Drug Substance (DS) CMC regulatory activities, focusing on antibody–drug conjugates (ADCs), chemical payloads, and bioconjugates.Author and review clinical regulatory submissions from scratch (IMPD/IND, CTD Modules 2 &...

  • Drug Regulatory Affairs Coordinator

    Vor 6 Tagen

    Basel, Schweiz CTC Resourcing Solutions Vollzeit

    **Drug Regulatory Affairs Coordinator** Our 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...

  • Regulatory Affairs Project Manager

    vor 6 Stunden

    Basel, Schweiz Alira Health Vollzeit

    Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Job Description...

  • Regulatory Affairs Manager 100%

    Vor 6 Tagen

    Basel, 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...

  • Regulatory Affairs Manager 100%

    Vor 6 Tagen

    Basel, Schweiz nemensis ag Vollzeit

    For our client, an international pharmaceutical company in Basel, 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...