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Regulatory Affairs Officer

Experience Dependent
Job Reference: J5634642
Updated On: 17/03/2021
Status: Now Interviewing
Hyper Recruitment Solutions
Sectors: Pharmaceutical, Chemicals, Nutraceutical, Life Sciences, Cell & Gene Therapy

Skills: Regulatory Affairs - Permanent, Quality Assurance - GMP, Regulatory Affairs - EU, Regulatory Affairs - UK, Regulatory Affairs - Global, Regulatory Affairs - CMC, Regulatory Affairs - Registrations, Regulatory Affairs - Administrator, Regulatory Affairs - FMCG, Regulatory Affairs - OTC, Regulatory Affairs - Drug Safety, Regulatory Affairs - Entry Level, Regulatory Affairs - Generics, Regulatory Affairs - Biologics, Regulatory Affairs - ATMPs

Job Information

Role Overview

Are you an experienced Regulatory Affairs Officer looking for a new exciting job opportunity?

We are currently looking for a Regulatory Affairs Officer to join a growing, highly regulated contract manufacturing organisation supporting both the Pharmaceutical and Healthcare markets based in the Hertfordshire area.

As the RA Officer you will provide regulatory and technical support to the Technical, R&D, Business Development and Quality departments with specific focus on food safety and pharmaceutical regulations in the EU/non-EU and emerging markets.

Key Duties and Responsibilities

Your duties as the RA Officer will be varied however the key duties and responsibilities are as follows:

1. You will be responsible for the strategic development and creation of CMC submission documents and life cycle activities as well as work across multiple teams and secure support from the department leads (R&D, Quality and Production, etc) to ensure that company products, which are developed, manufactured and distributed meet the required standards and legislations and regulatory commitments are met.

2.You will manage the generation, review, approval and submission of product dossiers and Chemical Manufacturing Control (CMC) regulatory activities for herbal products. This includes Active Substance Master Files (ASMF) and Drug Master Files (DMF) for products approved by BD Pipeline & Projects committee against the agreed timelines (as per the guidelines of each country) and in Common Technical Document (CTD) format.

3. Additionally, as the Regulatory Affairs Officer, you will be responsible for initiating proactive discussions with regulatory authorities to resolve technical regulatory queries relating to product submission and act as the regulatory contract to understand, interpret and advise teams on regulations, guidelines, procedures and policies relating to development, registration and manufacture of a new pharmaceutical substances, to expedite submission, review and approval of global CMC applications.

4. You will also be responsible for market surveillance for changes in regulatory legislation and guidelines in the pharmaceutical, cosmetic, and food and drinks industries, maintaining records where required.

Role Requirements

To be successful in your application to this exciting opportunity as the RA Officer we are looking to identify the following on your profile and past history:

1. Relevant degree in science, and/or extensive regulatory experience within a GMP regulated environment, preferably pharmaceutical. Regulatory experience in active substances or herbal substances is highly desirable.

2. Experience of quality management systems, preferably in a GMP regulated environment and knowledge of cGMP and food safety requirements is essential.

3. Capable of working with large volumes of data, with a focus on data checking, bulk uploading and electronic submission with great accuracy.
Debra Fong
Your Recruitment ConsultantDebra
DisclaimerHyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.