Associate Director Of Regulatory Services

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 Associate Director of Regulatory Services to lead and grow the regulatory project management, regulatory publishing/operations, and regulatory intelligence functional areas within Synterex. This role may manage and mentor direct reports within some or all the various functional areas on the global team.

The Associate Director or Regulatory Services reports into the Executive Director of Medical Writing and Quality Assurance and will partner cross-functionally with client teams in Clinical Development, Clinical Operations, Biostatistics, Regulatory, and Program Management in planning, preparation, and/or oversight of high-quality submission dossiers in CTD format. The Associate Director or Regulatory Services also will be responsible for oversight and review of dossier publishing and planning components or intelligence reports prepared by team members and vendors/contractors.

This is a full-time exempt role.

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 position will be responsible for the management and oversight of the following areas:

Regulatory Project Management

• Work with internal stakeholders and clients to ensure clearly identified project scope and deliverables
• Identify and recommend solutions for timeline risks and obstacles; engage appropriate stakeholders and ensure that all issues arrive at a conclusion or recommendation
• Ensure that clients have appropriate project management support for regulatory submissions such as an original IND, NDA, or MAA or with daily type submissions (briefing books, annual reports, etc.)
• Review project tasks to confirm they are appropriately identified and resourced, processes are well defined, and tools are implemented to facilitate team success
• Generate periodic status updates, reports, dashboards, and presentations on projects as appropriate

Regulatory Publishing/Operations

• Facilitate the compilation of regulatory submissions and, if applicable, submission to appropriate health authorities such as the FDA
• Oversee document-level publishing to ensure the technical preparation of regulatory source documentation (eg, MS Word formatting, PDF creation of hyperlinks and bookmarks) is eCTD compliant
• Ensure delivery of high-quality, timely, and compliant regulatory submission documents based upon client requests and applicable health authority regulations and guidances
• Supervise the internal archiving of regulatory submissions that have been sent to the health authority

Regulatory Intelligence

• Lead regulatory intelligence initiatives and projects as assigned
• Grow the regulatory intelligence capabilities within the organization

General

• Perform other related tasks or duties as assigned
• Cultivate a collaborative environment and growth mindset
• Facilitate cross-functional communication to support timely sharing of information and changes to client requests
• Develop and measure key performance indicators (KPI) for the functional areas

Requirements

• BS degree in a scientific field, with 8 years of experience in a biotechnology or pharmaceutical setting; Advanced degree preferred.
• Ability to work seamlessly with all levels of personnel
• Excellent written and verbal communication skills
• Excellent word processing, SharePoint, Excel, E-mail and online meeting tool skills
• Strong interpersonal and leadership skills to influence without authority, motivate others, and manage conflicts
• Regulatory experience within the biopharmaceutical industry or relevant experience, including a proven track record of successful regulatory project management and regulatory operations experience

For further information or to apply, please reach out to [email protected].

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.