Regulatory Senior Manager - Brexit
- Experience Level
A leading pharmaceutical client is searching for a Regulatory Senior Manager - Brexit to join their team in Hertfordshire. The company specialises in various therapy areas including oncology, neurology, and gastroenterology and employs several thousand across the globe.
The Senior Manager will report to a Director, and support one of the company's key assets. The role will be responsible for life cycle maintenance for this asset and providing strategic support for the activities. They will represent the team with regards to these activities at project teams and at senior management updates, as required.
- Develops and implements regulatory strategy for own functional area and region.
- Leads issue resolution of regulatory risks by identifying, escalating and monitoring issues.
- Organises resources and processes across multiple teams/functions to develop and deliver complete regulatory submissions within agreed timeframes.
- Provides regulatory support to project teams for allocated projects.
- Contributes to the planning, execution, and assessment of product life cycle management activities and strategies.
- Contributes to, and implements, strategy for interactions and negotiations with health authorities.
- May autonomously handle routine communications with regulatory authorities.
- Enhances the capabilities of current resources (tools, systems, vendors, etc.), technologies, and processes for the team.
- May manage contractors and ensure that contractors, consultants and vendors complete assigned work according to agreed timelines.
- Resolves expense issues and manages costs of work teams before issues arise.
- Manages team finances in compliance with financial standards and guidelines.
- Assist the review of 3rd party (contractors, consultants and vendors) work product and deliverables to recommend approval of payment of invoices or escalate issues when appropriate.
- Provides feedback, sets clear tasks and objectives and coaches team members on a periodic basis.
- May support employees by providing input into recruitment, selection, performance, succession, and transition activities.
- Trains team members on processes and/or systems.
- Manages individual contributors.
- Manages all employee-related activities throughout the year, including performance management and development.
- Identifies and communicates the skills, behaviours, and experiences required to develop employees.
- Sets goals, reviews performance, and provides feedback on a regular basis.
- Assists or Leads training of junior staff.
- Complies with all applicable laws/regulations of each country in which we do business.
- Demonstrates high ethical behaviour at all times, whether dealing with colleagues, vendors, patients, or physicians.
- Reports legal, compliance and ethical violations in a timely manner.
Skills and Requirements:
- BS/MS in relevant field.
- Experience in regulatory methods and processes in industry setting required.
- Proven knowledge of UK regulations including clinical trial regulations.
- Experience in liaising with regulatory authorities (both in writing and verbally).
- Life cycle management for Centralised products, including Type I and Type 2 license variations, line extensions, and negotiating labelling with regulatory authorities.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Robert Esposito at +44 203 761 5702 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.