Regulatory Affairs EU Manager
Location: High Wycombe
Salary: up to £65,000 + 5% bonus
Hours: Monday to Friday 37.5hpw
Job Type: Permanent
The company is an established EU pharmaceutical company that specialises in manufacturing drug products for Pain, addiction, critical care, ophthalmics and hospital steriles.
The company vision is to become European leaders for the treatment of addiction, pain & critical care, helping patients around the world gain access to high quality, essential and affordable medicines.
Also, the company has an international presence in the following regions/markets outside of EU, including MENA, AFRICA, APAC, US, China, and Canada.
You will be reporting to Head of Regulatory Affairs, the function of role holder is to manage the day-to-day activities of EU regulatory affairs team and regulatory support for regulatory submissions, agency responses and internal informational queries associated with Company’s product portfolio.
You will be ensuring that new products are developed in line with the EU regulatory requirements of targeted countries, obtains expedient registration of these products in a cost effective, timely manner and maintains the registrations of existing products in compliance with applicable legislation.
Recruits, develops, motivates and retains appropriately skilled regulatory team to support company’s objectives.
Duties may include interfacing with regulatory agencies as well as multiple cross functional stakeholders and project teams in order to proactively plan, coordinate and procure specialty documentation required to support EU regulatory submissions.
This individual will be responsible for providing management reports, project related metrics, and monthly highlights.
Main Responsibilities and Duties
* Line Manage a team of 3-4 people (Senior/Regulatory Affairs Officers)
* Provide managerial support and training to employees by supervising establishing employee goals that align with business goals, maintaining job descriptions, creating employee development plans, providing performance feedback and recruiting, motivating and retaining team members
* Must be collaborative and able to influence change
* Must be flexible and strive for continuous improvement
* Able to work in a global environment with multiple and diverse cross functional teams and subject matter experts/ corporate partners
* Cross culturally competent and customer service oriented
* Able to work independently and proactively search out solutions to challenges, by obtaining data from multiple and diverse resources, required to support global regulatory submissions
* Requires minimal supervision for project oversight/ execution
* Demonstrates initiative by providing input with respect to continuous improvement opportunities for tools, systems and processes
* Able to identify risk, mitigations and resolutions to be presented to cross functional teams.
Experience and Qualifications
* Direct people management experience
* Minimum of 7 years Regulatory Affairs experience which includes the Preparation of modules for the regulatory dossier in eCTD format, submission of variations, renewals new licence application submissions using national country specific procedures, Good Knowledge of Regulatory European procedures and regulatory filings
* Proven experience in EU regulatory affairs within development and established products environments
* Sound knowledge of applicable EU Regulations, Directives and Guidance
* Experience of managing a product through the CP/DCP/MRP/National approval processes
* To have an organised, methodical approach to work in order to meet deadlines
* Excellent communication skills including the ability to influence by persuasion and, where appropriate, negotiation. With an ability to communicate complex information to all levels
* People skills are important for this role in terms of managing relationships within the business and with business partners and in terms of participating in cross-functional working
* Well-developed analytical and problem solving skills
* Meticulous attention to detail
* Computer literate in Microsoft Office and Adobe Acrobat
* Ability to multitask
* Exceptional organisational skills including the ability to prioritise effectively
* Educated to degree level, ideally in Pharmacy, chemistry or life sciences
* Membership of The Organisation of Professionals in Regulatory Affairs (or eligible to be a member) would be an advantage