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EMEA Regulatory Affairs Manager - Oncology
Requisition ID: 1805640916W
EMEA Regulatory Affairs Manager - Oncology
Location : High Wycombe, UK or Leiden, NL
Pay Grade : 30
Closing Date : 23rd April 2018
Are you ready for that next step in your career and want to take the opportunity to become part of the success story behind one of the world’s most comprehensive and broadly based provider of health care products and related services?
At Janssen, we are looking at a future where the world of healthcare will be challenged by informed and empowered patients. We work for change that will improve access to medicines and that’s why we strive to provide access to effective medicines and related health care services to the people who need them.
Partnering with academic researchers around the world, we bring innovative therapeutic solutions to key unmet needs.
Our mission is to make the most fundamental change in the way diseases are managed. We have a leading portfolio of solutions that can alleviate, contain or cure some of the world’s most serious conditions and diseases.
To ensure that we can deliver our commitments to patients, customers and investors who rely on us, we work side-by-side with healthcare stakeholders and build on our people's talent.
Janssen has an
exciting opportunity for an experienced Regulatory Affairs Manager to
join our experienced Oncology team. This is a permanent role.
What you’re great at:
• European and/or Global regulatory experience
• Full product lifecycle experience
• Strong regulatory strategy experience
• Regulatory Oncology experience
• Team Work & Sharing Best Practice
• Credo & Operating Principles
As a Regulatory Affairs Manager, your essential functions may include:
• Supporting all
regulatory activities associated with the development, post-approval and
life-cycle management for designated products within the Oncology portfolio
• Providing regulatory content support for products by interacting with project teams, LOCs and regulatory agencies (as appropriate) and supporting submissions as appropriate.
• Providing guidance and support to product development teams on regulatory issues.
• Contributing to the definition and development of new processes, standards or operational plans in support of the organizational/ business strategies, with a direct impact on business unit/function overall results
• Excellent relationship building skills with the ability to communicate at all levels
• Knowledge of how Health Authorities operates and a good general knowledge of HA organizational structure and individual responsibilities in those structures
LIVE OUR CREDO: builds trust; tells the truth; initiates transparency into problems; demonstrates genuine caring for people.
CONNECT - works well and communicates effectively (verbally/in writing) across functions and groups; builds teams or networks effectively; inspires followership; champions best practices.
SHAPE - The ability to identify a problem, obstacle or opportunity and to take action to address current or future problems or opportunities. Awareness of one’s own level of knowledge; accurate assessment of when to seek help versus act independently. An underlying curiosity and desire to know more about things, people or issues. Ability to persuade, convince, or influence others, in order to gain support for an idea or a course of action he or she wants others to adopt.
LEAD - assumes personal ownership and accountability for business results and solutions; consistently delivers results that meet or exceed expectations; makes the customer central to all thinking; keeps the focus on driving customer value.
DELIVER – proactively senses and responds to problems and opportunities; works to reduce “cycle” time; takes action when needed.
What we’re about:
We are passionate about our work, and play vital roles across a range of professional disciplines, and care deeply about our customers and communities. At Johnson & Johnson our culture enables dynamic and impactful careers. We share a kind of DNA where we’re each
• Committed to caring
• Responsible to our communities
• Ready to apply our knowledge and know-how
• Unique in our background and experiences
• The drivers of our own success
• Passionate about doing what’s right
Make a unique mark in your career
If you want to be seen for the talent you bring to your work, be the driver of your own career, and work with others who share your passion for caring and success, then we invite you to join the Johnson & Johnson Talent Community by visiting http://www.careers.jnj.com/
#HEMAONCOWe respectively request Government Officials to identify themselves as such on application; for the purpose of the Foreign Corrupt Practices Act. If you decide to apply for the position, any personal data which you provide shall be processed by Johnson & Johnson Medical, a Johnson & Johnson company. Your personal data shall be processed for the purposes of recruitment, recruitment policy and selection.
United Kingdom-England-High Wycombe
Janssen Cilag Ltd. (7360)