Are you looking for a regulatory affairs leadership role where you will have the opportunity to maximize the value of systems investments in Global Regulatory Affairs, and be accountable for driving technology capabilities? If so, this Sr. Director- Regulatory Innovations Solutions Architect role could be an exciting opportunity to explore.
As Sr Director, you will maximize value of systems investments in Global Regulatory Affairs (GRA) by ensuring the function has optimized its process enabling systems to deliver timely submissions, improve the availability of information to drive faster decisions making, achieve best in class compliance, and increase business value by strengthening our interoperability with other systems and functions where appropriate.
This role will serve as a catalyst for GRA by driving forward solutions identified by the LT that enable the GRA process and systems transversally and to ensure the function possesses the right tech and capabilities to achieve optimal output from RIM and other related systems/processes.
This critical function will be accountable for driving technology and embedding technical capabilities across GRA and related domains that enables the function(s) to support current and future portfolio needs and optimize business capabilities.
You will be able to help reshape the GRA tech landscape to further align and enable optimized business processes as well as define new opportunities for further optimization that has a demonstrated value back toward upper quartile performance in the areas of efficiencies, cost savings and compliance.
This role will provide/gives YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…
- Prepare staff to strengthen technical capabilities for modernized ways of working and ensure these capabilities are appropriately embedded throughout the org.
- Closely partner with the VP of Regulatory Platforms and Systems (RP&S), as well as the Head of Regulatory Systems and Process, to deliver simplified solutions across the RA ecosystem and leverage expertise in systems, business process, and data movement by leveraging support learnings to further optimize:
- Regulatory Submissions Planning and Tracking
- Regulatory Submissions Content creation and EDMS
- Regulatory Publishing
- Archive and Retention
- Partner/consult with the Head of Regulatory Information Management to build better tools for critical information management and visualization (e,g, Correspondence Chronologies, Ever-Ready materials for inspections/due diligence, tools for tech transfer support, methods for legal holds).
- Partner with vendors, the Head of Submission Production and MSRs teams to design/implement and integrate updates and/or replacements to the Regulatory publishing and viewing system
- Consult the Master Data Management/IDMP lead to ensure systems related opportunities and tools to ultimately measure value beyond compliance.
- Partner/consult with the Head of Regulatory Systems and Process to streamline system/process training materials and prepare staff for a robust ‘train-the-trainer' program.
- Partner/consult across the RP&S Leadership team, along with Tech, to ensure Upper Quartile enabling technologies are in place (e.g. Setting up and leading POCs for Structured Content Management, Robotic Process Automation, Artificial Intelligence and Machine Learning capabilities) and demonstrate value for management.
- Leverage external networks to ensure GSK is working in line with industry standard or better.
- Provide expert consult to the Regulatory Policy and Advocacy team toward future data driven submission activities.
- Influence and rally stakeholders toward solutions to complex issues and render Regulatory Platforms and Systems vision into actions on the Global Regulatory roadmap.
We are looking for professionals with these required skills to achieve our goals:
- BSc/Bachelors or equivalent.
- 15+ yrs experience of regulatory affairs and the requirements for information management and exchange globally.
- Expertise in various Regulatory Information Management related solutions (EDMS, Publishing, Registrations data and archives).
- Expert level problem solving and interpretation of regulatory and business requirements, as well as deep understanding of technology offerings and IT architecture.
If you have the following characteristics, it would be a plus:
- 5+ yrs experience with Agile and similar frameworks
- 2+ Experience with data standards (e.g. ISO IDMP)
- Proven capability as a senior, global leader with advanced knowledge of development and life cycle processes and laws and regulations affecting the pharmaceutical industry in key jurisdictions, particularly European regulations and key non EU markets
- Proven track record of effective collaboration with regulatory agencies and a history of success in gaining product approvals and maintaining established products
- Excellent communication skills both oral and written. Proven ability to communicate with clarity, impact and passion. Commands attention and interest through use of appropriate communication techniques.
- Ability to work with remote teams/individuals and manage these teams through influencing skills while exhibiting sensitivity to and an understanding of different working styles.
Our values and expectationsare at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigour and risk, governance and control, managing ambiguity and paradox.
- Managing individual performance.
- Creating a performance culture and driving results, prioritization, execution, delivering performance.
- Setting strategic direction and leading on-going organizational transformation.
- Building strong relationships and collaboration in service of common goals, engaging the organization and building trusted external networks for mutual benefit.
- Managing P&L and capital allocation.
In return for your expertise, GSK will offer you the opportunity to showcase your skill set with a leadership that values, recognizes and rewards talent!
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