Regulatory Product License Support Manager 20325-1

Regulatory Product License Support Manager 20325-1
  • Competitive
    HOUR
  • Kent, England, UK Kent UK CT13 9NJ
Job Ref: J2161870
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 10 September 2021
SRG are recruiting for a Regulatory Product License Support Manager on a 6 month contract basis.

SRG are currently looking for Regulatory Product License Support Manager for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory team on an initial 6 Month basis to be based at their office in either Kent or Remote Working.

The Role:

A Product License Support Manager will ensure compliance is maintained by delivering the portfolio of one or multiple applicable regulatory obligations. The Product License Support Group comprises coordination of regulatory compliance starting at drug development stage and reaching through the lifespan of the Product. In addition, in support of EEA markets, team members will be accountable for partnering with appropriate vendors in submission of A57 records to the EMA . Team responsibilities also include managing the coordination of regulatory ancillary documents (including legalization) and drug samples to support registration and approval products in International markets.

Key Responsibilities:

  • Support delivery of electronic and paper regulatory transactions and electronic review aids in support of Drug Listings, Drug Establishment Registrations, certificates and samples sourcing, XEVMPD submissions and other post market scheduled regulatory compliance activities in accordance with 21CFR 314.81.
  • Continuous Improvement of selected processes relating to human health submissions and selected drug and non-drug specific projects and related activities e.g. Drug listing and Establishment registrations.
  • Delivery of Product License Support Portfolio in a timely and quality manner.
  • Contribute to the completion of project tasks and/or milestones and organises own work to meet project task deadlines
  • Implement solutions through interaction with other team members, and key contributors across sites, ensuring ability to maintain compliance with assigned processes and continuously improve on those processes
  • Participate on global/local teams to complete assignments and tasks within a specific task force/project. Contributes to the completion of moderately complex projects.
  • Liaise with internal stakeholders for issues regarding standards and processes and drives resolution of these.
  • Utilise support of electronic technologies for submissions and tracking of documentation
  • Manages own time to meet agreed targets; develops plans for short-term work activities on own projects (timelines, work plans, deliverables) within a Work Team.
  • Applies technical skills and Work Team knowledge to achieve assigned work on projects/assignments
  • Utilizes regulatory expertise, experience and technical skills to deliver on moderately complex tasks to support submissions to the Regulatory Authorities

Skills/Experience Required:

Qualifications:

  • Undergraduate degree plus relevant experience as below, or
  • Demonstrated fluency with regulatory submissions publishing and understanding of application of technologies.
  • Regulatory Expertise: Demonstrated knowledge of Regulatory compliance requirements, processes and systems
  • Demonstrated Project Managements Skills: Competent illustration of processes, tools and techniques for planning and monitoring multiple complex projects to established deadlines.
  • Technology: Experience and competency with Regulatory software, XML, Document Management, regulatory milestone reporting tools.

Skills:

  • General knowledge of CFR as it relates to specific post-market submissions
  • Ability to communicate information and analyses to a variety of audiences both verbal and written format
  • General knowledge of processes, tools and techniques for planning and monitoring multiple projects to established deadlines.
  • Understanding of applicable filing regulatory guidelines and fluency regarding order and presentation of regional and national regulatory dossiers
  • General knowledge of drug development process
  • Demonstrated knowledge of CFR as it relates to specific post-market submissions
  • Demonstrated coordination of activities in a highly regulated environment
  • Proven aptitude in project management and logistics
  • Demonstration of experience working in a challenging customer service environment
  • Proven experience managing or delivering through others in a team environment
  • Understanding of applicable filing regulatory guidelines and fluency regarding order and presentation of regional and national regulatory dossiers
  • Formal training in technical tools
  • Knowledge of drug development process

If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: corinne.laurence@srgtalent.com or +441615077288

SRGTalent
10/10/2021 11:29:20
GBP Hour
Contact Consultant:
Corinne Laurence

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