Global Regulatory Leader (Associate Director or Director level)
Location : Allschwill, Switzerland
Actelion Pharmaceuticals, a Janssen Pharmaceutical Company of Johnson & Johnson, is recruiting for a Global Regulatory Leader (Associate Director) for one of our leading compounds. The position will be based in Switzerland (Allschwil) but other locations could be considered if a frequent travel to Allschwil is possible.
As part of the Janssen Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, diagnose, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it.
Actelion is a leader in the field of pulmonary arterial hypertension (PAH). Our portfolio of PAH treatments covers the spectrum of disease, from WHO Functional Class (FC) II through to FC IV, with oral, inhaled and intravenous medications.
We are part of Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Global Regulatory Leader for PH TA Projects integrates multiple
inputs from regional and functional Global Regulatory Team (GRT) members to
create coherent and unified global regulatory strategies. Key activities and
responsibilities Include 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.
- Lead 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.
- Ensure regulatory strategies are updated throughout lifecycle of compounds as appropriate.
- Refine regulatory strategies as new data become available and re-assess as necessary.
- Develop and update 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.
- Lead the preparation of regulatory dossiers for submission to Health Authorities (HAs).
- Establish Rapid Response Teams as necessary to develop and obtain alignment on global strategy for responses to HAs.
- Work with the GRT to deliver input for target labelling, and the Labelling Working Group in making strategic decisions, including the creation of Labelling strategy.
- Participate in and conduct licensing evaluations as needed.
- The role will require business related travel up to 20% of the time. If the position is located remotely, frequent visits to the Allschwil site to participate in meetings is required.
Results and Performance Driven/Initiative: You will be assuming personal ownership and accountability for business results and solutions; you can easily identify a problem, obstacle or opportunity and act to address current or future problems or opportunities.
Organization and Talent Development: you have a Proven ability to foster the long-term learning or development of others.
Impact and Influence: Your able to persuade, convince, or influence others, to gain commitment with an idea or a course of action he or she wants others to adopt.
Organization Awareness: You understand the power relationships in one’s own organization and in other organizations.
Self-Awareness and Flexibility: You are 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: You are 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
- 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
Minimum 4 years of 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
- Deep understanding of biology and chemistry relevant to the Oncology therapeutic area requirements
- Experience developing regulatory strategies and an understanding of product development
- This role could be considered as Associate Director or Director, depending on experience
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Actelion Pharmaceuticals Ltd (Swiss Confederation) (8542)