Senior Associate - Regulatory Affairs
- Employer
- i-Pharm Consulting
- Location
- England, London
- Salary
- Negotiable
- Start date
- 7 Sep 2020
- Closing date
- 21 Sep 2020
View more
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Experienced (non-manager)
Job Details
Senior Associate Regulatory Affairs
12 Month Contract
1.0 FTE
Uxbridge - UK
Please note International relocations will not be considered for this role
Job Description
The Regulatory Professional under the direction of a Regional Regulatory Lead will assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead.
Assist Regional Regulatory Lead to support regional regulatory pre-filing activities (e.g. core CTA/IMPD development and submission, support for pre-MAA filing, regulatory authority meeting preparations)
Provide and maintain CTA/MA documentation support (e.g. variations, substantial amendments, PDCO annual reports) in collaboration with Regional Regulatory Lead
Create and maintain product regulatory history documents through IMR/rRISE and appropriately archive all regulatory documents and agency communications
Review regional component of the Global Regulatory Plan and provide input to operational deliverables
Ensure compliance via timely submissions to regulatory agencies
Support RRL in review of promotional materials for commercial activities (ex-US)
Collaborate with CRO�s / partners to support site initiation
Coordinate collection of functional documents in support of regulatory applications
As appropriate participate in GRT to support execution of regulatory strategy
Coordinate QC of regulatory documentation (e.g. briefing packages)
Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
Prepare regulatory packages and cross-reference letters to support investigator initiated studies
Complete regulatory forms to support agency communications (E.G. EudraCT,)
Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area teams
Support process improvement initiatives, standards development, and metrics
Assist in template development and maintenance
Respond to specific requests from and communicate relevant issues to GRT Develop Regulatory Position with teams
Actively support regulatory compliance
Support the development and execution of GRT goals
Key Skills
At least 3 years of experience in a Regulatory Affairs role in Pharmaceutical industry
Must have Regulatory Affairs experience concerning CTA's and MAA's
Strong communication skills - oral and written
Organizational skills
Understanding of drug development process
Company
i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.
We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, and Los Angeles. In a highly competitive marketplace, we connect top talent with the very best opportunities.
Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world.
With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.
For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them.
As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.
We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.
- Website
- http://www.i-pharmconsulting.com/
- Telephone
- +44 (0) 20 3189 2299
- Location
-
52 Bedford Row
London
England
WC1R 4LR
United Kingdom
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