Regulatory Affairs Manager (OTC) - Reading - 12mnth - £600/£700

  • Location

    Reading, Berkshire

  • Sector:

    Healthcare

  • Job type:

    Contract

  • Salary:

    £600 - £700 per day

  • Contact:

    Christopher Hague

  • Contact email:

    christopher.hague@experis.co.uk

  • Job ref:

    BBBH118678_1581526482

  • Published:

    about 2 months ago

  • Expiry date:

    2020-03-13

  • Start date:

    ASAP

  • Client:

    #

Regulatory Affairs Manager (OTC) - Reading - 12 Months - £600/£700 Per Day

Regulatory Affairs Manager (OTC) - Reading - 12 Months - £600/£700 Per Day

The work location is based in Reading on a 12 month contact duration.

Pay rate is between £600 - £700 per day

Qualifications and Require Skillset

  • Degree or equivalent in life sciences, chemistry or pharmacy
  • Sound knowledge of European regulatory requirements and specifically the UK regulatory environment
  • At least two years' experience in Regulatory Affairs, with experience in managing projects
  • Preferable, but not necessary, to have previous knowledge and experience of OTC products
  • Along with experience of regulatory affairs for medicines, it would be desirable to have some knowledge or experience in other legal categories (cosmetics, medical devices and food supplements)
  • Demonstrable ability to prepare high quality regulatory submissions
  • The role requires a person who is a self-starter with a positive outlook who possesses knowledge in dossier compilation activities and application of good regulatory practice in provision of advice and strategy to internal partners
  • Ability to communicate effectively and assertively with sound negotiating skills. Communication skills are pivotal to the role both for the internal and external interfaces. Ability to be able to communicate complex information to all levels
  • Customer focused and team spirited
  • Requires good attention to detail, presentation skills and problem-solving abilities
  • The ability to manage several projects at the same time by applying project management skills
  • Process driven. Able to make recommendations for improvement to existing processes or construct new processes with input from cross functional groups

Major tasks and responsibilities of position

Portfolio Maintenance:

  • To recommend and devise regulatory strategy, advise line management and seek agreement, then prepare and submit submission for responsible portfolio for extension applications, variation applications and article 61(3) (Directive 2001/83/EC) submissions in order to maintain current portfolio of products on the market compliant with regulatory requirements
  • In collaboration with Regulatory Assistant ensure that renewal applications and PSURs are prepared and submitted to meet statutory time frames
  • Complete review of Product Quality Reviews in accordance with regulatory requirements and internal process
  • Responsibility for product information (label and leaflet), SmPC, VMS review sheets and cosmetic PIF within agreed portfolio, in order to ensure they are maintained to statutory requirements and are fit for purpose by preparing the documents and co-ordinating their internal review and approval

Npd:

  • To contribute to the development process by identifying, then recommending (following agreement with line management) regulatory strategy for local projects in order to get new products on to the market in the shortest time by evaluating options and making clear recommendation to line management and then the relevant internal partners, highlighting the potential risks and benefits of the various options
  • To coordinate the preparation of submissions (e.g. marketing authorisation applications (MAA), switch applications, variations) with internal Partners as appropriate, e.g. Marketing, International Regulatory Affairs, R&D and local Quality functions
  • Support preparation for Health Authority scientific advice meetings when required
  • Submit MAAs to Health Authority ensuring agreed timeframes are met and all components of submissions meet agreed internal quality standards. Communicate with Regulatory Authorities on the status of applications and respond to and discuss requests for further information

Global Projects:

  • To input into the development of the regulatory strategy and data requirements for global projects where UK and/or Malta are featured as target markets
  • Provide regulatory support in the preparation of health authority scientific advice meetings

Regulatory Knowledge And Intelligence:

  • To keep fully abreast of on-going project activities within the area of product responsibility in order to keep line management aware of all developments (by communicating projects on an ongoing basis as required and via a monthly status report)
  • To provide regulatory advice to internal partners including Medical, Marketing, Quality, Business Development, International Regulatory Affairs and other R&D functions in order to contribute to development and marketing processes by actively participating in discussions relating to projects
  • Keep abreast of national and European regulatory requirements relating to the portfolio (medicines, food supplements, cosmetics and medical devices) including legislation, guidelines and best practice.

If you are relevant or interested don't delay, contact me on 0161 924 1416 or email me at