Global Regulatory Affairs Leader
Proclinical have partnered exclusively with this innovator pharma company in Basel, Switzerland, and they are currently recruiting for a Global Regulatory Affairs Leader. This position offers an exciting opportunity to work with a prestigious and international pharmaceutical establishment that provides real regulatory expertise.
- Facilitating and coordinating of GRTs, representing Global Regulatory Affairs and providing regulatory expertise to the Compound Development Team (CDT) and Clinical Team (CT).
- Facilitating successful product development globally and providing input on governance recommendations.
- Leading GRT(s) to develop global marketing approval submission plans and timing, modify these plans when necessary, and align with sourcing, Intellectual property and launch strategies as appropriate.
- Ensuring regulatory strategies are updated throughout lifecycle of compounds as appropriate.
- Refining regulatory strategies as new data become available and re-assess as necessary.
- Developing and updating contingency plans for issues that affect registration scenarios and continued lifecycle management of the product, and ensure strategy is in alignment with Therapeutic Area portfolio, regional strategies, CMC-Regulatory Affairs strategy, commercial and market access strategy, and the Target Product Profile.
- Leading the preparation of regulatory dossiers for submission to Health Authorities (HAs).
- Establishing Rapid Response Teams as necessary to develop and obtain alignment on global strategy for responses to HAs.
- Working with the GRT to deliver input for target labelling, and the Labelling Working Group in making strategic decisions, including the creation of Labelling strategy.
- Participating in and conduct licensing evaluations as needed.
- Results and Performance Driven/Initiative: Personal ownership and accountability for business results and solutions; easily identifying a problem, obstacle or opportunity and acting to address current or future problems or opportunities.
- Organisation and Talent Development: Proven ability to foster the long-term learning or development of others.
- Impact and Influence: Persuade, convince, or influence others, to gain commitment with an idea or a course of action he or she wants others to adopt.
- Organisation Awareness: Understanding the power relationships in one's own organisation and in other organisations.
- Self-Awareness and Flexibility: Able to keep one's emotions under control and act expertly when faced with conflict from others, or when working under conditions of stress; puts interest of enterprise above own; keeps the focus of driving customer value and delivering results under stressful situations; the ability to adapt to, and work effectively within a variety of situations, and with various individuals or groups.
- Strategic and Conceptual Thinking:
- Driven to envision a better future; takes any role or job and makes it better; has committed dissatisfaction with status quo; motivated to leave things better than they were; a change agent.
- Able to identify patterns or connections between situations that are not obviously related, and to identify key or underlying issues in complex situations; includes using creative, conceptual or inductive reasoning.
Skills and Requirement:
- Minimum of bachelor's degree in a scientific discipline required.
- Advanced degree (MS, PhD, MD or Pharm D) strongly preferred.
- 8-10+ years of pharmaceutical industry or health authority experience and at least 6 years of RA or related experience.
- Experience within a supervisory capacity or managing teams within matrix environment.
- Wide range of experience in Global Regulatory Affairs and experience leading interactions with Health Authorities (FDA, EMA, PMDA, CDE, etc.)
- Working knowledge of WW HA laws, regulations, guidance and global regulation submission routes available for new study drugs.
- Detailed understanding of competitors in the area and what they are doing in early/late development and knowledge of labelling aspects.
- Experience developing regulatory strategies and an understanding of product development.
- Good interpersonal skills, including communication, collaboration, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, strategic thinking, manages complexity, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Alex Czuprynski at 0203 869 2329 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.