The only artificial intelligence assisted medical writing service in the pharmaceutical industry. This transformative technology helps clients to better meet global transparency and disclosure requirements.
Submission Management - our suite of products consists of the solutions regulatory operations professionals need to efficiently manage and publish, validate and review eCTD submissions.
Regulatory Operations Services - submission and publishing services for marketing and pre-marketing applications as well as subsequent lifecycle submissions to support original applications.
Document Management - an intuitive, affordable document management system that reduces complexity form a user perspective while meeting the same robust standards for security and regulatory compliance
This combined knowledge makes Synchrogenix the consultancy of choice for life science and biotechnology companies worldwide.
Synchrogenix was named one of the INC 500/5000 Fastest Growing US Companies in 2012, 2013, and 2014 and has been named a Best Place to Work multiple times.
Synchrogenix was founded on the principles of ethical business practices and high-quality work. It is a learning-oriented organization with a strong commitment to the idea that every individual—regardless of experience level—has something to teach and something to learn.
Synchrogenix has built its culture on:
The European Sr. Director Regulatory Operations Services primary responsibility is to ensure the success of the Regulatory Operations Submission services within Synchrogenix from 3 perspectives: delivery, promotion, and process.
As the Regulatory Operations Services lead, serve on the Synchrogenix Services management team to structure the services team to be aligned with business objectives.
As a senior consultant, the Sr. Director, Regulatory Operations Services will provide expert Regulatory Operations Services to customers and serve as the lead consultant on projects. The incumbent can provide most professional services offerings of Synchrogenix, and will ensure project success.
As a subject matter expert (SME), the Sr. Director, Regulatory Operations Services is required to stay abreast of the latest regulatory changes and to ensure that information is disseminated throughout the organization. As an SME, the incumbent will promote Synchrogenix software and services and find new prospects and assist in closing new business. In addition, contributions to the success of promotional activities including proposal development, webinars, trade shows, training seminars, and other events is essential.
The Sr. Director, Regulatory Operations Services will use their experience to ensure SOP’s and best practices are developed, maintained and followed for professional services group. Key metrics will be developed, measured and monitored to detect performance and areas for improvement.
Lead Submission Publishing team within Synchrogenix Professional Services Department. Monitor team capacity and ensure department is staffed appropriately to meet Synchrogenix Professional Services Department goals, objectives and commitments
Serve as SME on service engagements ensuring timely delivery of services, mitigation of risks and client expectations are exceeded
Determine and manage work efforts to be completed and assist on completing work when required
Monitor trends, new information and changes in regulatory and disseminate information within the organization
Write newsletter articles, blog entries, and whitepapers to support marketing efforts
Serve as SME during sales calls, determine project scope and write proposals to support sales efforts
Present information at trade shows, training seminars, road shows, webinars, and other campaigns
Identify opportunities to penetrate client accounts for selling new products and services
Create processes, procedures, and best practices for all areas involved in professional services and its interactions with other departments
Seek ways to improve the regulatory operations function
Identify and maintain metrics to determine performance and ensure improvement
Provide contributive information to Synchrogenix products and services to lead to further development of offerings. This includes strategic planning to tactical activities, including tasks such as product positioning, pricing and promotion, product portfolio management, competitive strategy, making build/buy/partner decisions, and identifying and developing partnerships
Provide the sales team with the necessary technical expertise to enable them to sell services. This involves printed and electronic promotional material, services training, and relevant materials. Responsible for reviewing services data to ensure that the field force is kept up to date on new developments regarding the companies or competitors’ services.
Minimum experience of 10 years in regulatory operations; at least 5 years as a manager.
Proven track record of successfully implementing eCTD programs in companies and submitting all types of eCTD submission to major agencies.
Numerous speaking engagements on regulatory operation submission topics.
Technical competency to understand software, hardware, networks, etc.
Excellent written and oral communication skills.
Ability to quickly connect at a personal level and put people at ease.