Synterex, Inc. is a global consortium of highly experienced clinical development professionals specializing in medical writing, submission publishing, and clinical science and operations support. Synterex offers remote or on-site services, with a focus on providing clear, concise, accurate, and fully compliant documentation, from early drug development through post-approval.
Synterex is seeking an organized, motivated, and collaborative individual as the Manager of Regulatory Publishing and Operations to help grow the regulatory publishing and operations functional areas within Synterex. This role may engage within some or all the various functional areas on the global team.
The Manager of Regulatory Publishing and Operations will report into the Associate Director of Regulatory Services and may partner cross-functionally with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management in planning and/or preparation of high-quality submission dossiers in eCTD format. In addition to regulatory publishing and operations, the individual may also have opportunities to grow within the regulatory intelligence and regulatory project management areas.
Location:
Fully remote but must be able to attend key (e.g., business development, trade show, or roundtable or kickoff) meetings on site with clients as requested.
Essential Duties & Responsibilities:
The Manager of Regulatory Publishing and Operations will be responsible for:
- Prepare and execute document-level publishing of regulatory submission documents (e.g., MS Word formatting, PDF creation, PDF hyperlinks and bookmarks) according to health authority regulations/guidances, Synterex requirements, and client standards
- Compile and QC documents in regulatory submissions and, if applicable, submit to appropriate health authorities such as the FDA and EMA. Submissions may include but are not limited to IND/BLA/NDA/MAA/CTA, IND amendments, meeting requests, briefing books, and other standard- type submissions
- Responsible for routine management of Synterex’s regulatory information management tool, including setting up accounts, creating new applications, building submissions, and troubleshooting user issues
- Manage the internal archiving for regulatory submissions that have been sent to the health authority
- Has knowledge in appropriate ICH and FDA regulations pertaining to regulatory and technical requirements for electronic submissions; keeps up to date on the changing regulatory landscape
- Creates and manages submission timelines
- Cultivates a collaborative environment and growth mindset
- Facilitates cross-functional communication to support timely sharing of rapidly changing information and changes to client requests
- Participates in department growth initiatives, including but not limited to creation of department templates or job aids, metric displays, and lunch-n-learn presentations
- Performs other related tasks or duties as assigned
Qualifications:
- Bachelor’s degree in a scientific field
- A minimum of 3 years of pharmaceutical and/or medical device industry experience
- A minimum of 3 years of regulatory affairs experience in FDA-regulated products
- Knowledgeable of eCTD templates and structure of Modules 1 through 5
- Excellent word processing, SharePoint, Excel, E-mail, online meeting tool, and Adobe Acrobat skills; knowledge and/or experience with Adobe Acrobat add-ins preferred
- Knowledge of and some experience in regulatory information management tools
- Strong attention to detail
- Excellent interpersonal skills and solution/teamwork-oriented; able to work cross-functionally to share project information including status, results, project risks, etc.
- Ability to pivot and be flexible when new information is provided
- Excellent written and verbal communication skills. Flexible work schedule to accommodate periodic direct collaboration in various time zones for time-sensitive deliverables
- Common European Framework of Reference self-assessment English Level C1 or equivalent preferred
Synterex provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.