Regulatory Project Manager (Portfolio Management - Remote US Only)

Description

Regulatory Project Manager (Portfolio Management)

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Job responsibilities

The Regulatory Project Manager role is responsible for providing regulatory project management support to the growing FSP Portfolio. This person will be a part of the Regulatory Project Management Function and will support Global Regulatory Affairs.

Essential Functions of the job:

Build and Develop Regulatory Project Management Capability:

• Establish a robust regulatory project management framework, incorporating industry best practices, tools, and processes.
• Work with FSP Regulatory resource management and planning to integrate resource planning capabilities in Regulatory Project Management to support scalability and project efficiency across the organization.
• Partner with the Client Product and Portfolio Management for appropriate integration into the Global Product Team strategy, timelines, and reporting
• Assist in creating RPM tools, templates, and best practices, contributing to RPM initiatives

Strategic Project Oversight

• Guide the team in defining and communicating regulatory project strategies across the portfolio of disease areas, ensuring alignment with company objectives and regulatory timelines.
• Synthesizes cross-portfolio submission plans and reports that would include major milestones and key dates
• Provides reports/dashboards on progress of Global Regulatory Affairs organizational initiatives and provides an impact analysis to the business of those initiatives
• Analyze regulatory filings (e.g., INDs, NDAs, MAAs) and provide high-level analysis and strategies for executing across the regulatory portfolio
• Proactively identify and manage potential risks and challenges to ensure portfolio success.
• Serve as an escalation point for complex regulatory challenges, providing direction to Disease Area and Global Regulatory Leadership as needed.

Regulatory Compliance And Best Practice Implementation

• Maintain knowledge of current regulatory guidelines and requirements.
• Ensure adherence to FDA, EMA, ICH, and other global regulatory standards across all projects.
• Drive the implementation of best practices for regulatory portfolio management, maintaining consistency and efficiency.
• Work with Regulatory Intelligence to communicate regulatory landscape changes, and their impacts on the portfolio.

Stakeholder Engagement And Communication

• Act as a liaison between the Global Regulatory Affairs team and other departments, ensuring clear communication and optimal collaboration.
• Fosters effective and productive communication among various Regulatory Affairs groups including Regional Regulatory Leads, Regulatory CMC, Labeling, Advertising and Promotion, Regulatory Operations, and representatives from other functional areas, as appropriate.
• Provide regular updates to senior management on project timelines, risks, and achievements.
• Lead cross-functional meetings to facilitate project progress and stakeholder alignment.

Experience Required:

• Bachelor's degree in life sciences, pharmacy, regulatory affairs, or related field; advanced degree preferred.
• Minimum of 8 years of experience in regulatory affairs or project management within the pharmaceutical/biotechnology industry
• Experience should include 7-10 years of participation in cross-functional project management activities.
• Expertise in global regulatory submissions and familiarity with FDA, EMA, and ICH guidelines.
• MUST have managed multiple Marketing Applications and/or LCM submissions at the same time and in multiple regions from submission to approval.
• MUST have pharmaceutical development and regulatory global submissions experience.
• MUST have prior experience with both small molecule and biologics.
• Strong organizational, communication, and problem-solving skills, with a focus on continuous improvement.
• Familiarity with the following regions for filing submission: Asia Pacific, Europe, United Kingdom, Switzerland, Russia, South America, Middle East, China, Japan, United States.
• Strong PM fundamentals (meeting facilitation & management, timeline management, critical path assessment, risk and issues management).

Other Qualifications:

• PMP or similar certification preferred.
• RAC or similar certification preferred.
• Working knowledge with common project management systems required.
• Ability to multi-task and determine appropriate priorities if conflicts arise.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and project management software (e.g., Smartsheet, ThinkCell, Office Timeline, MS Project)
• Proficiency with Lucid Chart or Visio (a bonus)
• Proficiency with Regulatory Information Management Systems, such as Veeva Vault RIM

Qualifications

Experience Required:

• Bachelor's degree in life sciences, pharmacy, regulatory affairs, or related field; advanced degree preferred.
• Minimum of 8 years of experience in regulatory affairs or project management within the pharmaceutical/biotechnology industry
• Experience should include 7-10 years of participation in cross-functional project management activities.
• Expertise in global regulatory submissions and familiarity with FDA, EMA, and ICH guidelines.
• MUST have managed multiple Marketing Applications and/or LCM submissions at the same time and in multiple regions from submission to approval.
• MUST have pharmaceutical development and regulatory global submissions experience.
• MUST have prior experience with both small molecule and biologics.
• Strong organizational, communication, and problem-solving skills, with a focus on continuous improvement.
• Familiarity with the following regions for filing submission: Asia Pacific, Europe, United Kingdom, Switzerland, Russia, South America, Middle East, China, Japan, United States.
• Strong PM fundamentals (meeting facilitation & management, timeline management, critical path assessment, risk and issues management).

Other Qualifications:

• PMP or similar certification preferred.
• RAC or similar certification preferred.
• Working knowledge with common project management systems required.
• Ability to multi-task and determine appropriate priorities if conflicts arise.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint) and project management software (e.g., Smartsheet, ThinkCell, Office Timeline, MS Project)
• Proficiency with Lucid Chart or Visio (a bonus)
• Proficiency with Regulatory Information Management Systems, such as Veeva Vault RIM

Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

AtSyneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

The annual base salary for this position ranges $79,800- 139,600 USD. The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.