Regulatory Affairs Manager
- Employer
- i-Pharm Consulting
- Location
- England
- Salary
- Negotiable
- Start date
- 16 Apr 2021
- Closing date
- 30 Apr 2021
View more
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Management
Job Details
CMC Regulatory Affairs Manager - JP3647
Initial 6 month contract
Global CRO
Pay - £66 per hour/ €75 per hour if based in EU
Home based role in UK/Eu
Description
Prepare and review regulatory submissions
Provide regulatory strategy advice to internal and external clients
Provide project specific Global Regulatory Affairs strategy, technical expertise and co-ordination oversight for key client's projects
Ensure quality performance for key/managed projects Liaise with PPD globally to support global projects
Extensive contact with people throughout the company, with other regulatory consultants, with clients and with the regulatory authorities
Manage Project budgeting/forecasting
Assist in identifying and recognizing out of scope activities in a contract in a timely manner and liaise with Contracts & Proposals Team to follow through on all aspects of contract modification
Ensure compliance with relevant organizational and Global Regulatory Affairs Standard Operating Procedures and Working Practice Documents
Other duties as required
Requested experience
Must have strongly demonstrated Regulatory CMC experience across multiple product types (particularly biologics) and also strong demonstration in the authoring of multiple IMPDs and INDs
Professional experience within Regulatory
Proven people management experience
Bachelor or higher graduate degree in science-related field
Good knowledge of global / regional / national country requirements / Regulatory Affairs Procedures, with proven experience in at least one of the following areas;
Authoring Chemistry Manufacturing & Control documents for post-approval regulatory submissions
Development of product information for post-approval regulatory submissions
Working within Regulatory Information Management systems and submission publishing for electronic submissions to regulatory agencies
Regulatory submission experience in marketing authorisation applications
Expert knowledge of ICH and other global regulatory guidelines
Excellent English language skills
Effective oral and written communication skills
Good organizational and planning skills Ability to motivate and integrate teams and teach/mentor team members
Looking for CMC- experienced resources (regulatory manager level) to support current peak workload
- Experience to include biologics expertise and advanced therapy medicinal product (ATMP) (ie cell and gene therapy) expertise, if possible.
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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