Regulatory Affairs

1 week ago

Hemel Hempstead, United Kingdom PLATINUM RECRUITMENT CONSULTANCY LIMITED Full time

**Role**:Regulatory Affairs
**Location**:Hemel Hempstead, Hertfordshire

**Salary / Rate of pay**:£75,000

Platinum Recruitment is working in partnership with a niche pharmaceutical company, and we have a fantastic opportunity for a Regulatory Affairs to join their team.

**What's in it for you?**

My client is a fun, young, dynamic company with a rapidly growing team. As part of our growth plan, they now recruiting for a Regulatory Affairs
- Competitive salary
- A full time and permanent role
- Parking onsite
- Progression and development

**Package**
- £75,000

**Why choose our Client?**

A pioneering niche pharmaceutical company currently undergoing rapid expansion.

There are many opportunities for personal & career development in this fast-growing company. My client place great emphasis on developing staff, and strongly believe in an open, empowered friendly team culture.

Work closely with the medical profession, leading healthcare professionals and our international partners to ensure we provide outstanding service and quality

**The Role**

Responsibilities will involve:

- Working alongside the commercial department to determine the viability of entering new markets, and the regulatory requirements, timelines and conditions in these markets.
- Working alongside regulatory colleagues to transfer MAs worldwide back from the current MA holder.
- Reviewing and submitting artwork and labelling changes, including management of third-party artwork house.
- Managing external pharmacovigilance, medical information 3rd party agent, local translators, trademark providers, publishing, and consular service providers..
- Gap analysis of regulatory documentation, identification of potential challenges and proposal of solutions.
- Developing and maintaining strong working knowledge of regulatory guidelines.
- Liaising with regulatory authorities for advice and guidance when necessary, and to resolve issues to achieve the best possible outcome for the business.
- Ensuring all processes are carried out according to guidelines and standard operating procedures (SOPs).
- Knowledge/experience of submission portals i.e., MHRA Portal & CESP etc.
- Perform Global Regulatory assessment once a change is initiated and plan the submissions.
- Initiate, review, close and implement QMS related activities i.e., Change control, deviations & CAPA etc.
- Work along with logistic team and CMO to review and maintain the artwork and SKU log.
- Review of prescribing information as per ABPI/PMCPA code.
- Review and submissions of PSUR, RMP and CCDS.
- Support for the Annual Product Quality Review (APQR) for relevant product responsibilities.

**Essential Requirements**:

- Bachelor's degree equivalent or higher qualification within life science
- Strong knowledge of MHRA regulations
- Strong knowledge of GXP requirements
- Strong knowledge of ICH guidelines
- Knowledge of EU DCP/National and lifecycle maintenance
- Authoring & preparation of regulatory packages and documents for submissions
- Direct, hands-on experience of MA transfers
- Reviewing/annotating and approving artworks and labelling
- Experience working with regulatory agencies to clarify and resolve regulatory matters
- Ability to project manage and prioritise workload
- Attention to detail
- Positive can-do attitude
- Proficient in Excel and Word

**Preferred Requirements/Experience**:

- Change Control, Corrective and Preventive Actions (CAPA) & Deviation procedures.
- Knowledge of EU, Asia and MENA regulations and post approval procedures
- Conducting gap analysis and review of dossiers
- Implementing falsified medicines directive
- Creating and authoring SOPs
- Consolidation of dossiers into eCTD

**Sound like the role for you?**Then we would love to hear from you

**_Don't forget to speak to your consultant about our "Recommend a Friend" referral scheme and find out how you could earn up to £250 per recommendation._**

**Consultant**:Lisa

**Job Number**:919331/ **INDCOMM**

**Job Role**:Regulatory Affairs

**Location**:Hemel Hempstead, Hertfordshire

Platinum Recruitment is acting as an Employment Agency in relation to this vacancy.

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