regulatory affairs consultant in high wycombe

posted
job type
contract
salary
£ 100,000 per year
apply now

job details

posted
location
high wycombe, south east
job category
pharmaceutical
job type
contract
working hours
Full-Time
salary
£ 100,000 per year
reference number
RACJHW
apply now

job description

Are you an experienced Regulatory Affairs Consultant? Are you looking to take on a new challenge with a leading pharma client? If so we are looking for individuals just like you!

We have an opportunity for a Regulatory Affairs Consultant to join a leading client of ours to be responsible for advising the project team and/or regional therapeutic area leader on applicable regulatory issues, project-specific regulatory issues, and issues related to regional regulatory climates.

The therapeutic area for this role is Oncology.

This is a contract opportunity for 12 months initially, working 37 hours per week Mon-Fri.

Responsibilities:



* Drive understanding of central and national regulatory requirements
* Develop and ensure effective implementation of regional (central and national) regulatory strategy and tactics in support of the global development and life-cycle management plan
* Develop a deep understanding of the regional regulatory environment, competitor intelligence and therapeutic area
* Regulatory Agencies on product-specific labelling, study design, submissions content, and post approval commitments
* Ensure appropriate involvement and liaise with LOC regulatory affairs personnel to facilitate local Regulatory Agency meetings
* Determine timing and strategy for Regulatory Agency meetings and scientific advice
* Prepare team, manage, conduct and facilitate contacts/meetings with Regulatory Agencies.
* Define attendance in consultation with GRL and CDT. Issue minutes and contact reports and disseminate correspondence, faxes, contact reports from contacts with Regulatory Agencies
* Ensure that issues raised by Regulatory Agencies are promptly and adequately addressed
* Negotiate labeling with Regulatory Agencies, going through each of the back-up strategies if necessary
* Advise team on required documents and processes to support Regulatory Agency contacts and submission
* Plan and develop briefing documents for meetings with Regulatory Agencies, including determining content and review of documents
* Provide input to and review submission documents to ensure that they are fit for purpose and support labeling statements as appropriate
* Define, generate and submit appropriate data-driven (regional/local) responses to Regulatory Agency questions
* Ensure necessary regulatory activities are planned and adequately tracked in company systems
* Ensure protocols are developed in alignment with regional registration strategies to support registration, reimbursement and competitive labeling
* Advise team on required documents and submission strategies in preparation of CTA
* Ensure CTA submission packages are complete and available according to agreed timelines
* Provide regulatory support throughout registration process
* Provide regulatory support throughout life-cycle management
* Manage submissions, define submission plans, and advise team on required documents and submission strategies in preparation of MAAs (in collaboration with LOCs as appropriate)
* Ensure timely MAA availability, track critical path activities
* Responsible for submission and acceptance of MAA
* Ensure country-specific submission packages are made available to the LOCs

Qualifications and experience:



* University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience
* Breadth of regulatory experience in drug development and commercialization (e.g. experience in multiple products, multiple phases of development, multiple therapeutic areas)
* Experience with EU regulatory procedures (CP, MRP, national)
* Experience in working in project teams and/or a matrix organization
* Negotiating and conflict handling skills
* People management skills
* Complex project management skills
* Oral & written communication skills
* Organization & multi-tasking skills
* Knowledge of the applicable therapeutic area - Oncology
* In depth knowledge of the regulatory environment, guidelines and practice of EMEA regions

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.