Global Regulatory Cmc Lead

Vor 5 Tagen

Basel, Schweiz Hobson Prior Vollzeit

Hobson Prior are collaborating with a brilliant pharma establishment who are currently looking for an individual to join their team on a permanent basis located in either Basel or Stockholm. Our client is focused on offering novel remedies that will transform the lives of those suffering from rare illnesses. Th opening position is for a Global regulatory CMC Lead.

Please note that to be considered for this role you must have the right to work in this location.

**Key Responsibilities**:

- For this role, you will handle answers to queries from the authorities to guarantee early approval both in a timely and efficient manner.
- Engage wit regulatory authorities on reg CMC concerns.
- You will evaluate data offered to assist with preparing dossiers.
- Review submitted manufacturing alterations for international impact and offer regulatory tactics that assist the change execution.
- You will represent the regulatory affairs CMC division on allocated cross-functional project teams.
- Author/gather CMC sectors of regulatory proposals which involves clinical trial and variations/supplements and registration proposal globally.
- Any other assigned duties.

**Key Skills**:

- A high attention to detail with the ability to resolve issues.
- Able to make good judgements.
- Communication skills both verbally and in writing.

**Requirements**:

- Educated to a degree level in a life science discipline though an advanced degree would be ideal.
- At least 7 years of experience in CMC regulatory affairs with ongoing responsibilities.
- Exhibited knowledge within international CMC regulatory.
- Familiarity with new product registrations.
- Capable of handling communications with health authorities.
- Know-how of international regulatory guidelines.
- Acquaintance with planning electronic proposals.
- Capable of serving as a representative for CMC regulatory proposals as a member of project teams.
- Fluency in the English language.
- Computer literacy in PowerPoint, Word, Excel, etc.
- Exhibits the company's core values: Care, Ambition, Urgency, Ownership and Partnership.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

  • EMEA Regulatory CMC Lead — Strategy

    Vor 6 Tagen

    Basel, Schweiz Ultragenyx Vollzeit

    A biopharmaceutical company in Basel is seeking a Senior Manager for Regulatory Affairs CMC to lead EMEA regulatory strategies and support product development. Candidates should have over 6 years experience in Regulatory Affairs CMC, a BA/BS in life sciences, and a deep understanding of EMEA regulations. This is a 12-month fixed-term contract, requiring...

  • EMEA Regulatory CMC Lead

    Vor 2 Tagen

    Basel, Schweiz Ultragenyx Pharmaceutical Vollzeit

    A biotech company focused on rare diseases is seeking a Senior Manager, Regulatory Affairs CMC in Switzerland. You will lead the development of regulatory strategies and manage submissions for clinical and marketing applications in the EMEA region. Ideal candidates should have over 6 years of experience in Regulatory Affairs CMC, with a thorough...

  • Associate Director, Cmc Regulatory Science

    Vor 5 Tagen

    Basel, Schweiz Moderna Vollzeit

    **The Role**: **Here’s What You’ll Do**: - Develop/implement effective CMC regulatory strategies for global submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory risks - Provide guidance for regulatory CMC aspects of product development projects - Review documents for submission-readiness, to ensure that all submissions conform to health authority...

  • Regulatory Affairs CMC Manager, Drug Substance

    vor 2 Wochen

    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...

  • Basel CMC Regulatory Manager – ADC Drug Substance

    vor 2 Wochen

    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...

  • Associate Director, Cmc Regulatory Affairs

    Vor 5 Tagen

    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...

  • Regulatory Affairs CMC Manager, Drug Substance, ADC

    vor 4 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 &...

  • Ra Cmc Associate Director

    vor 1 Woche

    Basel, Schweiz Novartis Vollzeit

    576! That is the total number of projects and products on our Global Regulatory Affairs CMC project list. All of these innovative projects are aimed at making a difference in pa-tients’ lives and we need your help. As a member of our Global Regulatory Affairs CMC team, your role would be to establish and drive global CMC regulatory strategic and...

  • Senior Manager Regulatory Affairs CMC, EMEA

    vor 1 Stunde

    Basel, Schweiz Ultragenyx Pharmaceutical Vollzeit

    Why Join Us?Be a hero for our rare disease patientsAt Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go –...

  • Senior Manager Regulatory Affairs CMC, EMEA

    vor 1 Stunde

    Basel, Schweiz Ultragenyx Vollzeit

    Why Join Us?Be a hero for our rare disease patientsAt Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go –...