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- Aufgaben: Lead global regulatory strategies and collaborate with cross-functional teams to achieve regulatory goals.
- Arbeitgeber: Join a dynamic biotech/pharmaceutical company focused on innovative product development.
- Mitarbeitervorteile: Enjoy a collaborative work environment with opportunities for professional growth and leadership experience.
- Warum dieser Job: Make a real impact in patient care while working with diverse teams and driving strategic initiatives.
- Gewünschte Qualifikationen: Requires a scientific degree, 10 years in biotech/pharma, and strong regulatory experience.
- Andere Informationen: Fluency in English is essential; experience across cultures is a plus.
Das voraussichtliche Gehalt liegt zwischen 72000 - 108000 € pro Jahr.
Job Description
The Global Regulatory Lead (GRL) Consultant is a member of a GRA Global Product Strategy Therapeutic Area and contributes to the vision and goals for Global Regulatory Affairs (GRA) as:
- Regulatory leaders, who drive development and implementation of innovative, scientifically sound, prospective, global regulatory strategies for product/s, focusing on the patient and applying prudent risk-taking to achieve desired regulatory outcome.
- GRA representatives on Product/Project Strategy Teams (PSTs), key Delivery Teams (e.g., Clinical Development Teams (CDTs), Safety Management Teams (SMTs), Evidence Access Strategy Team (EAST)), and internal governance meetings as the single voice of GRA and lead the Global Regulatory Affairs Strategy Team (GRAST) for respective product/s.
- GRAST Leaders, engage GRAST members to achieve regulatory deliverables (including assign tasks) while fostering individual accountability and ‘team spirit’, drive alignment, act as decision maker for Team as needed, assess and communicate regulatory outcomes, encourage review/discussion, and contribute to or approve project-related deliverables (e.g. GRSO, TPP, TPC, CCDS, Protocol, CTD clinically-related sections, cross-functional education and influence Regulatory Intelligence/Policy) for the Team.
Required Profile
Requirements :
- Minimum 4-year university degree (or equivalent) in scientific field (e.g., biology/life sciences, pharmacy, chemistry/biochemistry, engineering/computer sciences, medicine), advanced degree desired (e.g., PhD, MS, MBA).
- Minimum of 10 years biotech/pharmaceutical industry, with 5 years regulatory experience, including 3 years in development.
- Direct agency interaction experience, preferably ICH regions, as well as exposure across multiple ICH health authorities.
- Team leadership experience, preferably 3 years as direct or matrix manager.
- Clinical (or Device/Combination Product) regulatory experience desired.
- Exposure to market access activities is desired.
- Applies Servant Leadership and Team Player principles to team environment, including leading without authority.
- Developing strategic ability to assess product vision and apply regulatory lens to effectively articulate regulatory assumptions, opportunities, and risks.
- Experience working effectively across cultures, inclusive and seeks out alternative perspectives when assessing potential outcomes.
- Fluent in English (written & verbal).
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Global Senior Regulatory Affairs Consultant Arbeitgeber: Consultys Switzerland
Kontaktperson:
Consultys Switzerland HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Global Senior Regulatory Affairs Consultant
✨Tip Number 1
Make sure to highlight your experience in regulatory affairs, especially any direct agency interaction you've had. This is crucial for a role that requires navigating complex regulatory landscapes.
✨Tip Number 2
Showcase your leadership skills by providing examples of how you've successfully led teams or projects in the past. Emphasize your ability to foster team spirit and accountability, as these are key qualities we value.
✨Tip Number 3
Demonstrate your strategic thinking by discussing how you've assessed product visions and articulated regulatory assumptions in previous roles. This will help us see your fit for driving innovative regulatory strategies.
✨Tip Number 4
Since this role involves working across cultures, be prepared to share experiences where you successfully collaborated with diverse teams. Highlighting your inclusive approach will resonate well with our values.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Global Senior Regulatory Affairs Consultant
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the Global Senior Regulatory Affairs Consultant position. Understand the key responsibilities and required qualifications, so you can tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in regulatory affairs, particularly in biotech or pharmaceuticals. Mention specific projects where you demonstrated leadership and strategic thinking, especially in a global context.
Showcase Team Leadership Skills: Since team leadership is crucial for this role, provide examples of how you've successfully led teams in the past. Discuss your approach to fostering accountability and collaboration among team members.
Demonstrate Cultural Competence: Given the global nature of the role, highlight any experience you have working across different cultures. Share examples that showcase your ability to seek out diverse perspectives and adapt to various regulatory environments.
Wie du dich auf ein Vorstellungsgespräch bei Consultys Switzerland vorbereitest
✨Showcase Your Regulatory Expertise
Be prepared to discuss your extensive experience in regulatory affairs, particularly in the biotech and pharmaceutical industries. Highlight specific projects where you successfully navigated complex regulatory environments and achieved desired outcomes.
✨Demonstrate Leadership Skills
Since the role requires team leadership, share examples of how you've led teams in the past. Discuss your approach to fostering accountability and team spirit, and how you've effectively managed cross-functional teams without direct authority.
✨Communicate Your Strategic Thinking
Articulate your ability to assess product vision through a regulatory lens. Prepare to discuss how you've identified regulatory opportunities and risks in previous roles, and how you communicated these insights to stakeholders.
✨Cultural Awareness and Collaboration
Given the global nature of the role, emphasize your experience working across different cultures. Share instances where you sought out diverse perspectives to enhance decision-making and project outcomes.
