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Principal Regulatory Consultant - Great company to work for.

Employer
Mosaic Regulatory Solutions
Location
Home Based / Herts
Salary
Flexible
Start date
14 Sep 2022
Closing date
14 Oct 2022

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Principal Regulatory Consultant

This company  has developed a deserved reputation for being a leading consultancy, with a wealth of regulatory and scientific knowledge and considerable experience in both leadership and management.

Our growing team of over 80 qualified professionals have a pharmaceutical and/or regulatory background. We provide services to over 130 organisations, enabling them to achieve their strategic and operational development objectives.

Their expertise and flexible working approach ensure the provision of a highly motivated team who interact effectively with clients and regulators globally, to support both single issue and long-term commitment to projects.

We are looking to expand our Regulatory Affairs team and are currently looking for an experienced Principal Regulatory Consultant to join us on a permanent basis.

This position can be based remotely or from our offices in Herts

The role:

The Principal Regulatory Consultant will be responsible for managing a portfolio of projects for a number of clients. This will encompass projects in clinical development, at MAA filing stage and post approval life cycle management.

Responsibilities:

  • Take responsibility for Company activities e.g. team building sessions, as requested.
  • Lead and support regulatory projects on behalf of the client including liaising and negotiation with regulatory authorities.
  • Manage and support regulatory procedures at both the national and EU level.
  • Manage and support US projects.
  • Prepare regulatory submissions including clinical trial applications and amendments, MAA dossiers and variations. Assist with preparation of scientific advice requests and PIPs and Orphan drug applications
  • Oversee preparation of regulatory submissions including clinical trial applications and amendments, scientific advice requests, PIPs, Orphan drug applications, MAA dossiers and variations.
  • Provide regulatory strategic advice on guidelines, legislation and procedures to clients on assigned projects
  • Analyse changes in the regulatory environment and legislation for impact on project/plans and the overall business.
  • Prepare and manage regulatory submissions and agency interactions.
  • Develop regulatory plans to meet project and client goals.

 

Qualifications / Experience:

Education

  • Educated to minimum BSc level within Life Sciences or Pharmacy.

 

Required Experience

  • Extensive experience working within Regulatory Affairs
  • Experience working with scientific advice requests, PIPs and Orphan drug applications is highly advantageous
  • Good work ethic & strategic mindset
  • Relevant life sciences degree
  • Experience working with EU requirements, US highly advantageous
  • Commitment to deliver client and company requirements by demonstrating a willingness to help others outside the individual responsibilities
  • Analyse and understand current and future regulatory environment and its impact on assigned projects and apply to the business environment.

 

We are a forward-thinking regulatory affairs consultancy, and takes the time to understand individual needs and find creative solutions for any regulatory challenge.

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Company

Mosaic Regulatory Solutions is a specialist recruitment consultancy founded in 2002. Set up to meet the ever increasing demand for regulatory professionals in a market place with a growing skills gap.

Our expertise lies solely in regulatory affairs recruitment. And as such we have a real understanding of this sector. As this is our technical specialty we remain industry leading and preferred supplier of choice to a number of clients and first port of call for many regulatory affairs professionals.

We understand team / environmental “fit” is vital so continue to find the right career and environment to suit all candidates.

Listening to client needs, we respond with a professional, seamless and pro-active style of recruitment.

Mosaic work with an ever growing client base with the UK and Europe. We are dedicated to providing long term relationships with clients and candidates. We are proud that a high percentage of our business is repeat business.

Company info
Website
Telephone
07951 082482
Location
Blackheath
London
SE3
GB

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