Monthly Archives: November 2016

Portfolio Management Associate – Portland, Maine

A great opportunity to develop a career in project management, with a global Animal Pharmaceuticals business. 

With a natural project management approach to the world, the Associate of Portfolio Management will assist in the project management of our client’s pipeline of animal health products in Product Development.

The Associate will report to the Manager, Portfolio Management. The Associate will be self-motivated, organized, detail oriented with a commitment to ensuring projects are completed correctly; maintain project plans using the information provided by project teams and provide project financial and status updates as required; willing to work on multiple concurrent projects with international project teams; and interested helping out wherever expertise allows.

Key Responsibilities

  • Maintain project plans using the information provided by Dechra project teams.
  • Provide project financial and status updates as required.
  • Balance the project management support needs of multiple concurrent projects with international project teams.
  • Provide additional project management support as needed to ensure the continued timely delivery of Dechra’s pipeline of animal health products.

Your Knowledge and Experience

  • At a minimum 2 years’ work experience within project management. Other relevant experience may be considered
  • Experience with project management tools (MS project or others) and methodology
  • Must be a team player with flexibility to get any task completed
  • Mandatory to have solid interpersonal skills and be adaptable
  • Excellent computer skills (MS Office) and an ability to pick up new systems & software, including MS Project and others as required
  • Demonstrate strong analytical & organizational skills with the ability to handle multiple tasks and prioritize
  • Knowledge of administrative and clerical procedures and systems such as word processing, managing files and records, designing forms, and other office procedures and terminology

 

The Company

Our client, Dechra, is an international specialist veterinary pharmaceuticals products business, with expertise in the development, manufacture, and sales and marketing of high quality products exclusively for veterinarians worldwide.

For further details contact Nick Farren – nick@allaboutthebrand.co.uk +44 7867 339009

 

Manager, Regulatory Affairs – Portland, Maine and Kansas, Missouri

Two Great Roles with a Global Veterinary Pharmaceuticals Business

In each of these global roles, one based in Portland, Maine and the other Kansas, Missouri, the Manager, Regulatory Affairs provides regulatory support and guidance for projects from inception through development and post-approval work for various submission types to ensure on time submissions.

The Manager, Regulatory Affairs compiles documentation and writes Module 2/Module 3 eCTD sections for ANADAs, PASs, and CBE-30s, develops CVM meeting requests, assists with launch initiatives, and assesses change controls for both drug substance and drug product.

The Manager, Regulatory Affairs utilizes a thorough understanding of FDA requirements and processes to support multiple products/projects simultaneously.

Key Responsibilities

  • Establish and create an ongoing working knowledge base of FDA/CVM requirements through CVM policy changes and learnings, from CVM feedback on submissions, and industry working groups.
  • Ensure that all project stakeholders (both internal and external) understand the regulatory requirements for their projects.
  • Work closely with the Senior Manager, Regulatory Affairs and Product Development teams to help identify and implement strategies needed to meet requirements for filings.
  • Ensure on-time submissions, critical databases are maintained, and that the RA workload is in alignment with project team needs (in control and run efficiently).

Your Knowledge and Experience

  • 5 – 8 years of experience with FDA regulations; CVM specific experience preferred.
  • Must have a working knowledge of pre and post approval submissions for solid oral and injectable dosage forms, APIs, cGMPs
  • Able to travel internationally (15%)
  • Self-motivated, detail orientated, collaborative, and able to support multiple tasks concurrently
  • Excellent written/verbal communication skills.
  • Familiarity with ADE/PQC (PV Works) regulations and electronic document publishing to support regulatory submissions is helpful.

The Company

Our client, Dechra, is an international specialist veterinary pharmaceuticals products business, with expertise in the development, manufacture, and sales and marketing of high quality products exclusively for veterinarians worldwide.

For further details contact Nick Farren – nick@allaboutthebrand.co.uk +44 7867 339009