Reporting to the Director of R&D Business Systems Regulatory, Health Registration Management (HRM), the Associate Director of Regulatory Business Systems Oversight, HRM, is accountable for providing operations of business systems established for Regulatory. This role is accountable for ensuring regulatory systems are fully supporting all phases of product registration and lifecycle management for organon products. This role drives strategic activities for regulatory business system capabilities in an alignment with the Executive Director of R&D Business Systems Regulatory. This role collaborates with the many stakeholders and users of the regulatory capabilities to plan and execute the operational business system activities.
The Associate Director of Regulatory Business System Oversight, Health Registration Management (HRM) is accountable and responsible for the following activities:
- Leads projects and initiatives supporting the long-term vision and strategy for regulatory business systems, helping to drive business outcomes.
- Ensures that tools, systems and procedures are align with business process and information needs for Chemistry Manufacturing Controls (CMC) and Manufacturing customers.
- Collaborates with these functional area contacts, process owners and IT product/account managers to develop business-related SLC documentation.
- Interface with CMC and MANUFACTURING DIVISON to understand, support and communicate the strategy and needs of that team as it impacts HRM data, systems and processes
- Operates the business system capabilities of the regulatory organization focused on registration management, partnering with external parties and other internal R&D functions where appropriate.
- Provides industry expertise and practical knowledge of current and emerging technologies and processes approaches within regulatory, including, but not limited to, registration, dossier publishing, and produce lifecycle management.
- Influences leaders to see new opportunities for enhanced regulatory business system capabilities.
- Proactively identifies new capabilities and enhancements that will improve regulatory and broader R&D operations.
- Functions as a contributing member of initiative teams which represents the strategic operations organization at both internal and external forums on regulatory business system capabilities for product registration and publishing as a representative of HRM
- Investigate, analyse and document user requirements, including but not limited to requirements definition, solution design, configuration and administration plan.
- Support system validation activities such as producing user acceptance/performance qualification testing scripts, executing the test scripts and monitoring.
- Ensure high ethical standards and a culture that values honesty, integrity, and transparency.
Education Minimum Requirement:
- Bachelor’s degree with 6+years of industry experience within a research and development organization, with 3 years in CMC or Regulatory area and experience with technical systems in a regulated environment or Master’s Degree and a minimum of 4 years of industry experience with 3 years in CMC/Regulatory area and experience with technical systems in a regulated environment
Required Experience and Skills:
- 3+ years of experience in a regulated research and development environment, preferably in the regulatory affairs product registration and lifecycle management domain
- Broad range of knowledge of regulatory processes
- Knowledge of Regulatory Filing procedures and/or Health Authority Registration process
- Ability to lead and influence others outside of a direct reporting relationship
- Broad organizational awareness and knowledge of touchpoints/interdependencies
- Must have proven track record to be able to think critically, strategically, independently and problem solve
- Must have high level of motivation, drive, and demonstration of Organon leadership values
- Excellent written and verbal communication skills including ability to write clearly and concisely
- Top notch interpersonal skills in difficult situations
- Driver of change and innovation
- Ability to work seamlessly with all levels of personnel
- Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.