Senior DRA project Leader
Location: United KingdomSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in City of London United Kingdom.
-Ensuring appropriate communication and correspondence from EMA/EU NCA to teams, management looking at communication routes.
- Leading the global submission planning processes
-EU labelling ( annexes, and documents) remain to be in compliance with CCDS, and EU/ICH regulations.
-Ensure that creation, reviews, finalisation of EU specific reg documents; i.e. IMPD, CHMP Scientific Advice and other meeting briefings, reports, drug applications, Module 1 Documents, PIP, are in order and contribute if needed.
-Providing consolidated interpretation of relevant Health Authority regulatory guidelines for the development and approval of new drugs as well as product life-cycle management.
- Lead regulatory sub teams at relevant points in development with communication of activities, and updates on a regular basis.
- Ensuring DRA projects and milestones are achieved and in line with project plans.
- Good knowledge of regulatory legislation and guidelines (ICH and EU) with global RA systems
- In depth knowledge and experience with EMA and NCA in EU and several types of EU submissions.
- Strong communication, negotiation, and project management skills.
- Familiarity with clinical trail methodology and statistics
- Strong project management skills related to the above area's
- Fluent in English
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Riko Arends.
The Company
We are currently looking for a Senior DRA project Leader in the greater London area and a medior DRA project leader for a large Pharmaceutical client of ours.Role Description
In this position you will be providing EU regulatory strategic input, including interpretation of guidelines relevant to the development and maintenance of assigned projects to the clinical teams, technical operations, global RA etc. There are several products that will be marketing within EU and they need someone that is able to coordinate and streamline this.Responsibilities
-You will be the liason with EMA as primary regulatory contact and other EU NCA in collaboration with some affiliates and partners for the assigned projects, this would include planning, coordination, preparation, and execution of the teleconferences and meetings.-Ensuring appropriate communication and correspondence from EMA/EU NCA to teams, management looking at communication routes.
- Leading the global submission planning processes
-EU labelling ( annexes, and documents) remain to be in compliance with CCDS, and EU/ICH regulations.
-Ensure that creation, reviews, finalisation of EU specific reg documents; i.e. IMPD, CHMP Scientific Advice and other meeting briefings, reports, drug applications, Module 1 Documents, PIP, are in order and contribute if needed.
-Providing consolidated interpretation of relevant Health Authority regulatory guidelines for the development and approval of new drugs as well as product life-cycle management.
- Lead regulatory sub teams at relevant points in development with communication of activities, and updates on a regular basis.
- Ensuring DRA projects and milestones are achieved and in line with project plans.
Requirements
- A minimum of 5+ years experience in regulatory affairs.- Good knowledge of regulatory legislation and guidelines (ICH and EU) with global RA systems
- In depth knowledge and experience with EMA and NCA in EU and several types of EU submissions.
- Strong communication, negotiation, and project management skills.
- Familiarity with clinical trail methodology and statistics
- Strong project management skills related to the above area's
- Fluent in English
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Riko Arends.
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