Sr. Principal Consultant, Regulatory Strategy and Advisory
Posted 1,463 days ago, which is unusual. The employer's own board was still carrying it when we last read it, just now.
This is the employer's own posting, not a copy on a job board.
What we know
Is it still open?
Confirmed still open
Last checked 2d ago — checked against the employer's own applicant tracking system, which is the company answering directly.
We re-read the employer's own applicant tracking system and the posting was still there. That is the company answering directly.
How old is it?
Posted 1463d ago
The date the source published, not the day we noticed it (2022-09-13). Last seen at its source just now.
Is it remote?
Marked remote on the employer's board
Their board carries a remote setting on this posting — a field they filled in, not wording we read. The location field names somewhere specific, which is usually where the team or the entity sits.
Who may apply?
Germany
The description states no restriction of its own. This is the source's own tag.
Skills named in the ad
Recognised terms only, from a fixed vocabulary — this is what CV matching compares against.
Carried by 1 source
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workable employer's own board first seen 11d ago · last seen just now
The listing
All candidates should have a passion for helping our clients navigate transformational change; We are looking for smart, self-driven, high-energy people with top-notch communication skills, intellectual curiosity.
The Candidate should have a rare blend of industry domain, process, technical and consulting skills. Industry domain expertise can be in one or more areas of Life sciences. Consulting skills should entail client relationship management, effective executive communication, critical thinking in a consultative approach with our clients. Additional skills that are highly desirable include value realization, process re-engineering, design thinking and agile delivery experienced
Role Summary, Core Expectations
- In depth knowledge of Pharma Regulatory Operations and Regulatory IT Systems aligned to core Functional and Technical competencies
- Expert in Regulatory and Clinical area with ability to drive futuristic IT solutions and experience in client facing and agency thought leadership.
- Understanding and knowledge of processes related to health authority submissions, content authoring, labeling, lifecycle management of CMC, regulatory intelligence, and country-specific regulatory requirements – keenly aware of industry trends, needs and business requirements expected from clients
- Able to strategize and advise on the product roadmap and should work closely with the client in delivering solutions.
- An empathic people manager responsible to mentor and guide a team for progressive outcomes
Technical Credentials:
- Should have master’s degree in a Life Science, Medical or Related discipline. Master’s in Business Administration would be an added advantage.
- Minimum 12-15 years’ experience in Drug development, Regulatory, Clinical Operation and Medical Devices.
- Deep understanding of RIM systems i.e., Veeva Vault, PARAXEL/LIQUENT InSight, CSC Regulatory Tracker, ArisGlobal Register, OpenText, SharePoint, Documentum, FirstDoc / FirstPoint, NextDocs, CARA, Extedo eCTD Manager, Trackwise, or other regulatory information management systems Submission and publishing tools.
- Knowledge of regulatory IT systems landscape and implementation experience inclusive of integration and Migration aspects
Responsibility of / Expectations from the Role:
- Work with Business Regulatory experts and IT Experts globally to analyze, develop, and implement Regulatory processes and provide solutions to business problems and support business in implementing innovative Regulatory Platform solutions, in the most agile ways of working.
- Design innovative product features based upon industry requirements for Health Authority submission management, content authoring, labeling, regulatory intelligence, country-specific regulatory requirements, and emerging standards.
- Formulate recommendations for improvement in business processes and system configuration, developing user requirements to facilitate solutions to achieve the business vision and address key use cases.
- Coordinate with the implementation team across multiple phases and workstreams (e.g., solution design and configuration, systems integration, data migration, validation, and training).
- Primary customer liaison managing communication between the project team, customer, and internal stakeholders and vendors.