Description:
Location: Belgium

Schedule: Contract - Full Time - Office based

TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for an Regulatory Affairs Program Manager for one of the most innovative pharmaceutical company in the world.

As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

The Regulatory Program Manager (RPM) functions as a regulatory submission leader driving projects forward through the translation of regulatory and compound strategy to executable plans and coordination of cross-functional team efforts. The RPM is accountable to both the Global Regulatory Leader and PMO leadership for planning, executing, controlling, and reporting the functional regulatory pathway. This individual provides operational and program management leadership to therapeutic product and platform development programs from approximately phase 2B until all major submissions are completed.

Main Job Tasks and Responsibilities:

• Empower teams to deliver the highest possible impact for our programs, business, and patients around the world
• Lead operations with Global Regulatory Team, including management of worldwide submissions, pre and post-submission activities, preparations for health authority meetings and additional major regulatory milestones
• Translate regulatory requirements and strategy into an executable plan at a level of detail that allows teams to understand what is critical at any one time, proactively identify and mitigate risks, and exploit meaningful opportunities for acceleration
• Submission Leader tasked with driving project management of the submission team by setting direction, raising issues, establishing team R&Rs, developing detailed submission plans, and maintaining a close eye on critical path and associated analytics
• Support GRT in a manner that fosters and maintains a high-performance team culture, chairing GRT, Submission Working Group, Rapid Response Team meetings, and similar, as required
• Ensure coordination of critical GRT information and team communications to ensure timely and accurate dissemination of the GRT strategy and operational status throughout the team and between co-development partners and/or other external partners, as required
• Provide global, cross-functional, operational leadership and management to drive risk management, prioritization, and decision-making, challenging the status quo and driving innovation
• Serve as primary PMO point of contact to ensure GRT/CDT functional plans are aligned with compound/program objectives and commitments
• Ensure the development and tracking of key messages and indication specific submission content maximizing the use of the Global Regulatory Strategy Plan and ensuring alignment with overall compound strategy
• Drive process improvements and embed best practices from across programs, TA's and functions into supported teams
• Work across functions and organizational boundaries to establish processes and procedures and new innovative methods that improve overall delivery
• As required, work with standard budgeting and forecasting process and reporting tools to build and maintain the regulatory components and health authority budget to an overall coordinated project plan in Planisware
• Support and facilitate activity, resource and cost planning across the R&D project portfolio, as required

Education and Experience:

• A minimum of a Bachelor's degree is required
• Post-graduate degree in life sciences, business management, regulatory affairs or related field is highly preferred
• Regulatory certification (RAC) is preferred
• A minimum of 5 years of industry/business experience, including a minimum of three years in pharmaceutical R&D or comparable R&D sector
• Experience in strategic planning, development of regulatory strategy, and cross functional management of global regulatory submissions and processes (e.g. NDA, MAA, and lifecycle documents)
• Demonstrated experience conducting business process, scenario, and critical path analysis
• Demonstrated understanding of Global Regulatory Affairs processes
• Knowledge of global regulations, guidelines and regulatory requirements
• Experience with clinical trial conduct, Phase I-Phase III

Skills:

• Leadership and management of global submission teams in a matrixed setting, with demonstrated ability to drive and expedite team decision making and translate strategy to clear, executable action plan
• Proficiency in the application of project management standards, planning and visualization tools (MSP experience highly preferred)
• Demonstrated ability to resolve controversy and influence teams without formal authority
• Proficient in written and spoken English
• Minimal local travel between sites
• Ability to work virtually

The Application Process

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002562

please contact Rocio.EgeaMota@cromsource.com for more information.

Who will you be working for?

About CROMSOURCE

CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

Our Company Ethos

Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates.

About TalentSource Life Sciences

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.

CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

Keywords: Regulatory Program Manager, Freelance, Regulatory
Skills: Freelance, Phase I, Regulatory Location: Belgium Share:

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