Manager, Regulatory Services
The Manager, Regulatory Services will be a team leader for document publishing projects, with a particular focus in the European region. He/she will perform eCTD publishing work and directly manage Regulatory Submission Specialists, as well as provide oversight and team guidance for publishing projects. The Manager, Regulatory Services will be responsible for ensuring publishing projects are delivered of high quality and on time. In addition, the Manager, Regulatory Services will directly interface with customers to manage aspects of the project including issue resolution and providing subject matter expertise for publishing related inquiries.
- Serve as a Subject Matter Expert for one or more specialty areas or submission types (e.g., EMA and Swiss eCTD applications, knowledge of EU Marketing Authorisation Procedures, Electronic Application Forms, Active Substance Master File (ASMF), Variations, Amendments, etc.).
- Independently perform eCTD publishing tasks and manage the publishing activities of Regulatory Submission Specialists.
- Manage, mentor, and evaluate the performance of Regulatory Submission Specialists. Promote and generate cooperation to achieve a collective outcome.
- Interacts with Clients to resolve issues, build relationships, and proactively anticipate future needs.
- Ensure documents are received and delivered according to timelines agreed upon with the Client’s representatives and that issues are resolved in a timely manner.
- Solve urgent submission problems independently. Manage submission-level issue on behalf of the Regulatory Submission Specialists.
- Utilize EMA Submission Gateway and Common Electronic Submission Portal; create media if required.
- Research and communicate industry best practices to internal and external audiences.
- Provide training on corporate policies, procedures, and best practices for team/Submission Specialists.
- Manage and support publishing project decisions.
- Proactively evaluate process work flows and software performance and actively define and implement improvements.
- Participate in the interpretation of new Regulatory Agency guidelines and rules.
- Represent Synchrogenix as a Subject Matter Expert at industry conferences and sales meetings with new and existing clients.
- Liaise with other departments and external vendors, managing deliverables and establishing strong relationships.
- Test and evaluate new software and operating systems to determine their capabilities and suitability for use by Regulatory Services.
- Ability to independently perform eCTD publishing tasks and manage the training and publishing activities of others.
- A proven track record of successful regulatory submissions and life-cycle management of regulatory applications.
- Understanding of regulatory and commercial landscape in the biotech/pharmaceutical industry.
- Experience with EMA and Swissmedic submissions; knowledge of US and ROW submissions; and an understanding of Regulatory Agency requirements.
- Expert knowledge of ICH/EMA/Swissmedic regulatory submission publishing standards and Guidance documents.
- Ability to serve as a Subject Matter Expert for one or more specialty areas or submission types (e.g., Marketing Authorisation, Amendments, Renewals, Variations, PSUR, ASMF, etc.).
- eCTD validation knowledge- EMA & Swissmedic.
- Excellent IT/computer skills.
- Strong attention to detail and organization skills.
- 5-7 years of relevant work experience.
- Undergraduate degree and/or equivalent experience.
- Occasional travel (~10%) may be required.
Synchrogenix, a Certara® company, is a global, multimillion-dollar regulatory and scientific writing company headquartered in Wilmington, DE, with US offices in Atlanta, GA; Thousand Oaks, CA; Cincinnati, OH; Philadelphia, PA; Raleigh, NC; Malvern, PA; Parsippany, NJ; San Diego, CA; Nashville, TN; Orlando, FL; Gaithersburg, MD; and Cambridge, MA. Synchrogenix has two wholly owned subsidiaries: Synchrogenix Europe Limited, headquartered in Daresbury, UK, with an additional office in London; and Synchrogenix Philippines Inc. (SPI), headquartered in Manila.
Founded in 1986, Synchrogenix takes a unique team approach to projects drawing from the varied skills and backgrounds of its writers and editors. This approach enables Synchrogenix to bridge all functional areas within drug development, with the singular focus on regulatory/medical documentation. Regulatory writing is truly an expertise, and Synchrogenix’s 150+ permanent writers and editors are among the best in the world.
Synchrogenix now offers additional technologies and services that expedite the regulatory process. These include:
• 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 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, 2014, 2016 and 2017 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:
• Being fast and flexible, non-hierarchical, apolitical, and non-defensive
• Active participation—nobody sits on the sidelines
• Teamwork—the company’s success is important to all of us
• Cross-functional communication (lots of it) and a high-tech culture that works to have everyone on the same page
• Disciplined leadership that inspires passion and commitment
• Personal accountability
• Strong peer and management support for those who want to learn