Regulatory Consultant (CMC experience within LATAM or APAC region required)Updated: January 10, 2025
Location: Mexico-Latin America - MEX-Home-Based
Job ID:25001074
Regulatory Consultant (CMC experience within LATAM or APAC region required) 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.
Job responsibilities Execute commercial Lifecycle Management (LCM) strategy and submissionsReview CMC sections of regulatory submissions, as well as interactions and responses with regulatory agenciesWork with regulatory colleagues in the development of global regulatory CMC strategies and submissionsManage and operationalize the delivery of day-to-day regulatory activities for assigned projects according to agreed timelines, scope of contract, budgets, and strategies.Participate as regulatory support on multidisciplinary project teams, which may include clinical and other technical experts, to develop products throughout their life cycle.Act as a subject matter expert and help team members with day-to-day troubleshooting activities, presenting solutions to project-related problems.Prepare estimates for conducting regulatory services as part of single or multiple service proposals.Support meetings with clients to discuss proposals, the status of ongoing projects, and as part of general business development activities.Ensure compliance with appropriate global regulatory requirements and the company's policies and processes.Prepare training materials and share best practices in the regulatory area, both internally and externally.Participate as regulatory support in internal or external project audits.Participate as regulatory support on internal cross-functional initiatives.Contribute to the creation and/or maintenance of SOPs and other process-related documentation as required.Provide support in oversight to team members in the execution of their project responsibilities.Maintain individual training records (Syneos Health or client-related) and completion of all designated required training.Qualifications What we're looking for BS or PhD degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field.
Moderate pharmaceutical/medical device related experience.Proficiency in regulatory (FDA, EMA, Health Canada and ICH) guidelinesExcellent interpersonal / communication skills including excellent written and verbal communication skills.Excellent customer service skills, with the ability to work both as a team member and independently.Good quality management skills.Advanced skills in Microsoft Office Applications.Ability to interact with staff from multiple departments and offices to establish project standards.Good initiative, adaptability, and proactivity.Strong analytical skills, good attention to detail.Ability to work concurrently on projects, each with specific instructions that may differ from project to project.Fluent in speaking, writing, and reading English.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.
At Syneos Health, we are dedicated to building a diverse, inclusive and authentic workplace.
If your past experience doesn't align perfectly, we encourage you to apply anyway.
At times, we take into consideration transferable skills from previous roles.
We also encourage you to join our Talent Network to stay connected to additional career opportunities.
#J-18808-Ljbffr