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Regulatory Affairs Manager, Midlands, UK
Senior Regulatory Affairs Officer/Experienced Regulatory Affairs Associate EMEA - Thames Valley, UK
Regulatory Project Manager, London, UK

Regulatory Affairs Manager, Midlands, UK
Company: Clinical Professionals Ltd
Location: Midlands, UK
Reference: J810117
Type: Permanent
Salary: Competitive
Expires: 28 February 2014

Job Summary:
Regulatory Affairs Manager - Midlands Are you looking to join a regulatory affairs department for world renowned company with both pharmaceutical, medical and generic products on their portfolio? This company have one of the largest generic and medical device product portfolio they have a large global presence and their offices are based in a picturesque location in one of the oldest towns in England.

Requirements:
Are you looking to join a regulatory affairs department for world renowned company with both pharmaceutical, medical and generic products on their portfolio?

This company have one of the largest generic and medical device product portfolio they have a large global presence and their offices are based in a picturesque location in one of the oldest towns in England. The company is a short walk away from a main line train station with links to Reading and London which is around one hour away.

Excellent Salary and benefits package
Free Car Parking onsite

The role has various duties including:
•Managing the regulatory affairs team
•Working with new licensing applications
•Preparing documents for registration
•Involvement in new product launches
•Reviewing and maintaining the department budget
•Reviewing promotional material, labelling and manufacturing
•At least five years experience of emerging markets experience
•Working knowledge of CMC and ability to review the regulatory dossier prior to submission to EU
•Experience of carrying out national, MRP, DCP and CP submissions

If you are a Regulatory Affairs professional looking for a challenge, please contact either Meera Chauhan on meera@clinicalprofessionals.co.uk Lorna Baker on lorna@clinicalprofessionals.co.uk or 01189594990

Senior Regulatory Affairs Officer/Experienced Regulatory Affairs Associate EMEA - Thames Valley, UK
Company: Meet
Location: London
Reference: REGG1EM
Type:Full Time
Salary: (£) 30,000 - 40,000
Expires: 27 February 2014

Job Summary:
This is a fantastic opportunity for a regulatory affairs associate with over 2 years’ experience working within a pharma/biotech/generics company. You will have plenty of opportunity to learn and progress within this organisation. You will be joining a regulatory team that provides support to activities outside of the UK/EU

Requirements:
You will be working with a range of specialist pharmaceutical products within EM regions, Middle East, Africa, CEE, Russia etc
- Provide regulatory support to this client’s markets outside the EU/UK: countries in the European, Middle East, Africa and West Asia (EMEA) region). The short term objectives of this role are to maintain existing licenses in the Emerging Markets region.
- Support new license applications within specific regions
- Liaises directly with local Affiliates, distributors or agents to define/clarify submission requirements, and follow up on submissions, requests for supplementary information and approvals

SKILLS DESIRED
- Must be authorised to work in the EU
- Should have a minimum of 2 years of regulatory experience within a Pharma or CRO
- Prior experience in regulatory submissions is desirable, or sound relevant industry experience.
- Must have experience of maintaining licences and new licence applications within international markets.

This position is dealt by Emily Gaffney at meet, on + 44 779 4411 452 or email directly at emily@peoplewithchemistry.com to discuss in confidence.

Regulatory Project Manager, London, UK
Company: Advanced Clinical Recruitment Ltd
Location: London
Reference: rapm_1
Type: Permanent
Salary: On Application
Expires: 28 February 2014

Job Summary:
This is a really niche regulatory project management opportunity based with a highly dynamic & evolving healthcare company. You will be responsible for leading regulatory projects for generic & specials products, line managing a team in the UK & India. If you are looking for an exciting & challenging project manager role, this will be the role for you!

Requirements:

Key Responsibilities will include:

To manage a Regulatory Team in India and UK on Module 2.
Prepare and review submission packages to the MHRA and IMB in a timely manner
Write and prepare responses to a high quality
To raise and action appropriate change control, maintaining compliance
To prepare and submit high quality submission for post approval activity to strict dead lines
Liaise with the Regulatory Authorities to ensure product approvals are received in a timely manner
Review artwork for national phase submission and prior to launch
Review health authority website for product safety updates and new requirements

The ideal Candidate will have:

MSc or BSc Pharmaceutical Science
Previous experience 6-10 years
Clinical Regulatory Organisation experience is preferable
Module 2 sign off ideal
Must have high attention to detail and proactive
Ability to prepare high quality regulatory applications and the ability to communicate effectively
Demonstrate excellent verbal and written English
Ability to handle multiple tasks in a fast-paced and constantly changing environment
Good knowledge of Microsoft word and excel
Ideally some knowledge of drug development
Ideally some knowledge of Decentralised procedures
Ideally a generics background
Experience working with Specials is highly desirable

Please get in touch with me Samuel Whyley-Smith on +44 (0)114 209 6321 or email me at ssmith@acr-uk.com

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