Regulatory Affairs Officer

2 months ago

Cheadle, United Kingdom Recipharm Full time

**Regulatory Affairs Officer **(37.5h/p)
- (Flexible working hours and remote working options available)_
**_Location: _**_ Manchester, UK_
Recipharm offers its expertise and facilities in the development, production and supply of pharmaceuticals to demanding customers for global use. Our mission is to be acknowledged as the best provider of contract development and manufacturing solutions to the pharmaceutical industry by our customers, employees and other stakeholders.
RPH Pharmaceuticals AB (RPP) is an operating company within Recipharm. Our rapidly growing and ambitious group seek you; an experienced and skilled regulatory affairs professional to join an expanding team. With offices in the UK, Sweden, India and Italy, you will be part of a fortunate team whose role will be to support the company’s product portfolio, as well as a strong and exciting product pipeline. You will be exposed to the challenging EU regulatory arena for human medicine via a wide variety of therapeutic areas and pharmaceutical forms including immediate oral release, parenteral preparations, drops, creams and ointments. Our company, with core values of tenacity, reliability, professionalism and entrepreneurship, has high expectations with an insatiable drive for success.

You will be confident in your ability to learn fast; operate under pressure; manage multiple projects simultaneously; deliver on tight deadlines; function well alone and within a multidiscipline team. You will have an exceptional eye for detail; robust verbal and written communication skills; confidence working with a wide range of IT software and programs.

This role would suit someone looking to take the next step in developing their career by immersing themselves in our friendly and supportive workspace with the abundance of new skills and experience on offer.

We look forward to meeting you
**The Role**
- Prepare, update, review and authorise CMC (Module 3) documents using primary source manufacturing records, protocols and reports (BMR, BPR, Test Methods, Stability Reports, etc.)
- Prepare, review and publish, in eCTD, New MA Applications (MAAs) for UK and EU territories as part of National, Decentralised or Mutual Recognition procedures
- Update product information (SmPC and Labelling) in line with current EU guidelines/requirements (e.g. excipient warnings, QRD etc.)
- For National, Decentralised or Mutual Recognition procedures; prepare, review, publish (in eCTD) and submit;
- Quality and Safety variations (Type 1A, Type 1B and Type II)
- Artwork (Labelling) changes, in accordance with Article 61.3
- Renewals
- Batch Specific Variations/Release (BSV/R), where applicable
- Prepare, review, publish and submit responses to authority questions
- Record and maintain licence particulars (Name, MA Number, Active, Manufacturer, ATC code, Excipient List, etc.) on Regulatory Information Management System
- Define new MA and Post Approval regulatory strategy; including prescription of supportive data and documentation
- General administrative duties pertinent to the function of the department

**Skills and Experience**
- Two or more years of relevant Regulatory Affairs experience
- Good working knowledge of CMC (Module 3)
- Experience in post-approval activities
- Knowledge and familiarisation with current UK and EU regulatory legislation/guidelines/requirements; ability to swiftly locate, digest and use information from primary online sources (e.g. EMA, CMDh, EDQM, MHRA, HPRA, FDA)
- Provide regulatory advice to support UK and EU strategy
- Ability to work autonomously or as part of a team
- High organisational skills and time management
- Ability to manage multiple tasks in balance
- Excellent IT skills

**Qualifications**
- Life Sciences Degree

**Other**
- Some European travel required as per business needs

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