Company: Pharmalink Consulting
Closing Date: 30 Nov 16
Type: Full Time
Salary (£): Competitive
Genpact Pharmlink is a highly specialized Regulatory Affairs Consultancy with a successful history. We have grown and developed our service offering through building relationships, listening to our clients’ needs and adapting our ways of working to meet the changing needs of regulatory markets around the world. It is this flexibility and adaptability that we look for in all of our Consultants.
Genpact Pharmalink is working on more client projects than ever before and they’re getting larger by the day. If you’re a Regulatory Affairs Project Manager, we’d love to talk to you!
The Regulatory Project Manager will work directly with some of the largest pharmaceutical companies in the world to drive regulatory projects forward and be accountable for deliverables.
As a regulatory affairs team representative, the Regulatory Project Manager may:
• ensure the project team understands requirements for new products, and regulatory implications with facility, product and process changes and improvements;
• Develop solutions to regulatory or business problems where no clear precedence exists.
• function independently as a decision-maker on regulatory issues; and must assure that deadlines are met;
• Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies.
• manage the various stages of a project lifecycle:
o Project Initiation – Compiles scope, resource, and cost information for project approval and tracks same through the project, reporting any scope changes related to timing, cost, or resources.
o Project Monitoring – Monitors project for timeliness (on-time) and financial adherence (budget/savings goals) and adherence to other project goals (improved quality, reduced complexity, etc.)
o Issue Management – When tracking behind, identify ideas to accelerate project and generate alternate solutions to project related issues.
o Escalation – Tracks major milestones and provides feedback to management when deviating and solicit management support when required for decisions or resolution of issues outside the control for the project manager.
o Project Close – Ensure smooth handover to appropriate participants at project end. Responsible to issue final project performances assessment and lead post launch review.
o Project Communication – Act as the key point of contact and project management both within the project team, across all project stakeholders, to the Senior Management Leadership Team and to the organization at large. Communication may take many forms including face-to-face meetings, web site updates, trainings, presentations, conference calls, etc.
o Promote Cross-functional Collaboration – Generally projects managed by the Regulatory Project Manager involve team members from a variety of functions within a client organization. It is pivotal that the Project Manager ensure that all necessary functions are aligned and involved in the right stages of a project.
• Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions
• Compile; prepare; review and submit regulatory submission to authorities
• Communicate application progress to internal stakeholders
• Evaluate proposed preclinical; clinical and manufacturing changes for regulatory filing strategies
• Provide strategic input and technical guidance on regulatory requirements to development teams
• Oversee processes involved with maintaining annual licenses; registrations; listings and patent information
• Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management
• Assist in the development of global regulatory strategy and update strategy based upon regulatory changes
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
• BS degree in health or science-related field
• Minimum 5 years’ experience with regulatory affairs project work within the pharmaceutical industry
• Excellent verbal, written and organizational skills.
• Strong Written and Verbal communication skills
• Ability to identify compliance risks and escalate when necessary
• Able to manage multiple priorities and projects and deadlines
• Team oriented individual with personal commitment to human relations, integrity, giving and receiving constructive feedback, adaptability, diversity working environment. Experience in third party contract operations is preferred.
• Preferred experience working in OTC, Pharma, consumer goods organization, managing cross functional teams, planning short and long term initiatives
Vanwall Business Park
|Tel:||+44 (0) 1628 860300|
|Fax:||+44 (0) 1628 860400|
|Website:||Visit Our Web Site|
PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.