Regulatory Affairs Manager

Location
England
Salary
Negotiable
Posted
16 Apr 2021
Closes
30 Apr 2021
Ref
CMCRAMAN
Contact
Guy Shipman
Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
Experience Level
Management

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.

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