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Senior Product Development Associate

Description

A fantastic opportunity is available for a Senior Product Development Associate to join on of our OTC team.  This role is responsible for our products in the US market and ensuring they adhere to the US FDA guidelines and requirements, agreed timelines, budget and quality standards. 

Responsibilities:
•    Management of the US portfolio and pipeline, ensuring the launch of a pipeline of products into the US market and the building of a strong 5 year + strategic pipeline. 
•    Through leadership skills and ownership of the pipeline ensure projects are delivered to the agreed timeline, budget and quality standards.
•    Proactively highlighting any budget or resource pinch points while contributing to the identification of solutions through solving project derived technical problems using experience, advice and technical support available.
•    Taking ownership of the entire product development (Analytical & Formulation) aspects of the products, performing gap analysis of the current data packages against US FDA guidelines and CMC requirements to ensure the products are suitable for registration through the US NDA process
•    Work collaboratively with the cross-functional team to build and leverage strong relationships with internal and external members to utilise when driving projects through to completion and overcoming roadblocks
•    Identify and drive the resolution of all issues, risks, risk dependencies and change management, and communicate effectively to senior management.
•    Use of metrics, systems and KPI’s to ensure Quality standards and practices are adhered to across the project

Qualifications/Experience

•    Educate to degree level such as chemistry, pharmacy, chemical engineering or other relevant science
•    Experience of product development process within an R&D Healthcare or FMCG or Medical Device environment, with a proven track record of delivering development projects
•    Experience working in an analytical/formulation environment with experience in trouble shooting day to day  challenges and work/resource planning 
•    Extensive knowledge of the US FDA guidelines and CMC requirements for registration of NDA
•    Previous experience of compiling an NDA submission and supporting the product through the registration process and to launch

Equality

All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law. 


Nearest Major Market: New York City
Nearest Secondary Market: Newark

Job Segment: Medical Device, Pharmacy, Healthcare

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