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- Aufgaben: Lead regulatory affairs and CMC strategies across multiple sites in a dynamic environment.
- Arbeitgeber: Join a growing company in Bubendorf, Switzerland, focused on quality and compliance.
- Mitarbeitervorteile: Enjoy flexible working hours and opportunities for professional growth.
- Warum dieser Job: Be part of a collaborative team making a real impact in drug development.
- Gewünschte Qualifikationen: Ph.D. in Chemistry or Pharmacy with 5+ years in regulatory affairs required.
- Andere Informationen: Ideal for those passionate about regulatory compliance and leadership.
Das voraussichtliche Gehalt liegt zwischen 72000 - 108000 € pro Jahr.
Senior Manager Corporate Regulatory Affairs & CMC (RAC)
As part of our growth strategy and succession planning, we offer a new challenge for a Senior Manager Corporate Regulatory Affairs at our site in Bubendorf, Switzerland. You will be a member of the Corporate Quality Organization responsible for Regulatory Affairs & CMC. You will elaborate and maintain the corporate RAC development standard in cooperation with the local regulatory affairs and CMC teams of the three Business Units (Drug Products; Drug Substance and Biologics & ADCs; Specialties for a total of 8 sites) and monitor its compliant execution. You act as a Business Process Owner for the corporate regulatory affairs systems like the e-submission software and the monitoring of the applicable regulation and guidelines. You provide regulatory affairs advice and hands-on support for local regulatory affairs internal improvement and customer projects as required.
Responsibilities:
- Supporting the elaboration, establishment, and application of the RA standard at all sites.
- Helping to ensure the internal standard in the regulatory compliance maintenance of the regulated products under consideration of customer requirements.
- Consulting the local RAC teams in developing the CMC and regulatory strategy for new development projects with customers and internal and external development groups as required and requested by the customer, ensuring that the corporate RAC standard is applied.
- Guiding operators through the issuance, submission, and maintenance of all regulatory documents (DMFs, CMC documentations for INDs, IMPDs, NDAs, MAAs, etc.).
- Providing hands-on support in the implementation and application of the corporate standard at the respective sites.
- Coordinating the regulatory activities of all CARBOGEN AMCIS RAC groups during the CMC process development for corporate projects and consulting the CARBOGEN AMCIS and customer project teams in regulatory questions as requested and agreed with the customer.
- Chairing the corporate RAC organization as part of the Corporate Quality Organization.
- Taking over process ownership of the RAC chapter in the Corporate Management Handbook, defining and maintaining a harmonized RAC standard.
- Maintaining the e-CTD submission software.
Requirements:
- Ph.D. Chemist or Pharmacist or equivalent scientist.
- Very good knowledge in RAC (drug substances and/or drug products) and CMC development.
- Good GMP knowledge.
- Familiar with e-CTD systems.
- At least 5 years of experience in an RA department (Drug Substances or Drug Products).
- At least 5 years of work or management experience in an RA/GMP environment.
- At least 5 years of experience in dealing with authorities and customers.
- At least 5 years of experience in leadership or consultancy.
- Good intercultural skills.
- Good to excellent communication style.
- Good English language skills, orally and in writing.
- Flexible working ‘attitude’ (ready to work overtime).
- Team-oriented leadership skills with strong decision-making capabilities.
- Service mentality.
For further information, please contact the Human Resources department.
Apply Now
Please complete the form with the relevant details and apply using the button below.
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Senior Manager Corporate Regulatory Affairs & CMC (RAC) Arbeitgeber: Carbogen AMCIS AG
Kontaktperson:
Carbogen AMCIS AG HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Senior Manager Corporate Regulatory Affairs & CMC (RAC)
✨Tip Number 1
Make sure to familiarize yourself with the specific regulatory frameworks and guidelines relevant to the pharmaceutical industry, especially those pertaining to drug substances and drug products. This knowledge will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the Regulatory Affairs field, particularly those who have experience in CMC development. Engaging with industry peers can provide valuable insights and potentially lead to referrals that could enhance your application.
✨Tip Number 3
Prepare to discuss your leadership experiences and how you've successfully managed teams or projects in a regulatory environment. Highlighting your decision-making capabilities and service mentality will resonate well with our corporate culture.
✨Tip Number 4
Showcase your intercultural skills and communication style during the interview process. Given the global nature of our operations, being able to effectively communicate and collaborate with diverse teams is crucial for success in this role.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Senior Manager Corporate Regulatory Affairs & CMC (RAC)
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure you fully understand the responsibilities and requirements of the Senior Manager Corporate Regulatory Affairs & CMC position. Tailor your application to highlight your relevant experience in regulatory affairs, CMC development, and leadership.
Highlight Relevant Experience: In your CV and cover letter, emphasize your 5+ years of experience in regulatory affairs, particularly in drug substances or drug products. Provide specific examples of your work with authorities and your leadership roles.
Showcase Communication Skills: Since good communication is essential for this role, ensure that your application reflects your ability to communicate effectively in English, both orally and in writing. Consider including examples of successful collaborations or presentations you've led.
Tailor Your Cover Letter: Craft a personalized cover letter that addresses how your background aligns with the company's needs. Mention your familiarity with e-CTD systems and your flexible working attitude, as these are key aspects of the job.
Wie du dich auf ein Vorstellungsgespräch bei Carbogen AMCIS AG vorbereitest
✨Showcase Your Regulatory Expertise
Make sure to highlight your extensive knowledge in regulatory affairs and CMC development during the interview. Be prepared to discuss specific examples from your past experiences that demonstrate your understanding of drug substances and products, as well as your familiarity with e-CTD systems.
✨Demonstrate Leadership Skills
Since the role requires team-oriented leadership, be ready to share instances where you successfully led a team or project. Discuss your decision-making process and how you foster collaboration among diverse groups, especially in a regulatory context.
✨Prepare for Intercultural Communication
Given the international nature of the role, emphasize your intercultural skills. Prepare to discuss how you've effectively communicated and collaborated with teams from different cultural backgrounds, ensuring that you can navigate the complexities of global regulatory environments.
✨Exhibit a Service Mentality
The job description mentions a service mentality, so be ready to explain how you prioritize customer needs in your regulatory strategies. Share examples of how you've provided hands-on support to clients or internal teams, ensuring compliance while meeting their requirements.
