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Lead Regulatory Scientist (Experience (Submissions (assess…
Lead Regulatory Scientist
Experience
Senior / Lead
provide strategic and technical advice
within the department
provide guidance on regulatory issues to support internal customers
across the business
Optimise / Improvement
current activities
efficiency
process improvement
future activties
development of best practises
SOP maintenance
tracking tools
templates
interpret and communicate impact analysis
Management
Responsible for National regulatory management
development of products
Primary Product contact
'product cross functionally'
Ensures questions and commitments from National regulatory authorities (UK, Ireland, Malta) are proactively managed.
range of medicines
UK or EU management of CP
MRP
nationally licenced products through MAA
clinical and technical variations
UK CTAs
Represent UK Regulatory Affairs
internal and external
interfacing with local medical and marketing teams and headquarters Regulatory
interface
Submissions
High quality
timely manner
collaboration with colleagues
maintain licence compliance
ensure approved changes are implemented
assess technical/scientific content of proposed national submissions to meet requirements
Propose solutions to correct deficiencies
Compliance
High ethical standards
within the team
maintained personally
full compliance
with all applicable laws
Regulation EU No 536/2014 (Old Directive 2001/20/EC)
Directive 2001/83/EC
regulations
understand and apply
industry codes
ABPI codes
promotion of medicines to health professionals and other relevant decision makers in the UK.
internal policies and procedures
other aligned areas
drug safety
clinical trials
development research
Skills
Personal abilities
Leadership
proactivity and department level approach to work
identify and understand key issues
propose and implement solutions with minimal guidance
communication
Build contacts
Negotiate
engage with both internal and external stakeholders
influence
liaise
attention to detail
accuracy
Workplace skills
Dossier writing
to advise on technical issues
Teamwork
teamplayer
support
Coach
provide guidance
collaborate
Good regulatory judgment
ability to interpret the view and the intent of regulators
scientific understanding
apply knowledge to new situations
Role requirements
Qualifications
Degree
Human physiology and Pharmacology
Lab skills , Literature review ,Report/essay writing
experience
Genetics
Immunology
Right for Roche
Forward looking
looking for opportunity to pursue interests across functions and geographies
go above and beyond
think beyond immediate responsibilities
innovative
Someone who wants to infuence
find, understand and apply regulations and guidance
Proactively seek specialist knowledge
own department
Know Brand Strategies
communicate regulatory activities and timelines to support brand planning
want to work for a company that is interested in your development and progression
willing to learn