senior regulatory affairs manager in high wycombe

posted
03 January 2019
contact
ruby willard, randstad cpe
job type
contract
salary
£ 80,000 - £ 105,000 per year
apply now

posted
location
high wycombe, south east
specialism
pharmaceutical
sub specialism
Quality
job type
contract
working hours
Full-Time
salary
£ 80,000 - £ 105,000 per year
reference number
SRAMANJHW
contact
ruby willard, randstad cpe
apply now

job description

Are you an experienced Senior Regulatory Affairs Manager? Are you looking to take on a new challenge with a leading Pharma giant? If so we are looking for individuals just like you!

We are looking for a Senior Regulatory Affairs Manager to be responsible for the management of processes to ensure compliance with regulatory requirements and an inspection ready culture.

This opportunity is a 6 month contract role working 37 hours per week Mon-Fri.

Responsibilities:



* Provide Regulatory support for a portfolio of promoted and non-promoted products
* Prepares and submits regulatory documentation with support from RSMO as required
* Monitors deadlines for different projects to ensure they are met or escalated to a Senior Regulatory manager and/or Head of RA
* Responsible for the content of the local labelling documents released to prescribers and patients
* Prepares and distributes local labelling documents within stipulated timelines followingreceipt of relevant approvals from RRR
* Prepares for and manages local procedures following the EMEA Regulatory Affairs strategic plan, assuring timely execution and compliance
* Partner with allocated CVT to provide RA expertise and support Implements of Risk
* Management Plans and when required co-ordinates cross functional team to implement/update Risk Management Educational Material
* Develops and maintain in depth knowledge of regulations/legislation
* Supports EMEA with collection of RA competitive intelligence as required
* Support other departments based on their needs (e.g. Supply Chain, Quality, Medical, and Commercial) by providing documentation and information in response to requests
* Support and contribute to GRA-EMEA initiatives as requested by Head of RA
* Contribute to initiatives around lessons learnt and change management to ensure efficiency gains
* Actively contribute to increasing the regulatory expertise of the team by mentoring of junior regulatory colleagues

Experience/Qualifications Required:



* Direct experience and strong knowledge of general regulatory requirements and guidelines
* Strong data gathering and analytical skills are essential
* Strong persuading/ influencing, negotiating skills are required
* Regulatory Affairs experience at operational level

Qualifications



* University Degree in Pharmacy, Biology, Chemistry or related Life Science
* Registration with official governing bodies e.g. General Medical Council, Royal Society of Pharmacists
* Member of The Organisation for Professionals in Regulatory Affairs
* Other special requirements
* Occasionally flexible work hours
* SOPs relevant to this role

If this role is of interest to yourself, and matches your skills sets and experience then please click apply below to submit your CV. Please ensure your up to date contact details are on your CV before applying. If your application is shortlisted, we will call you and discuss the role in further detail to ensure this role is what you are looking for and meets our clients needs.

Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.

Candidates must be eligible to live and work in the UK.

For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.