Regulatory Consultant (CMC experience within LATAM or APAC region required) Updated: January 10, 2025 Location: Colombia-Latin America - COL-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.
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 Execute commercial Lifecycle Management (LCM) strategy and submissions Review CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies Work with regulatory colleagues in development of global regulatory CMC strategies and submissions Manage and/or operationalize the delivery of day-to-day regulatory activities for assigned project 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 the 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.
Capable of identifying when to ensure line support required to provide additional guidance and direction.
Maintain individual training records (Syneos Health or client related) and completion of all designated required training.
Qualifications 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) guidelines Excellent 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.
Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.
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.
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.
Discover what our 29,000 employees already know: work here matters everywhere.
We work hard, and smart, all in the name of getting much-needed therapies to those who need them most.
A career with Syneos Health means your everyday work improves patients' lives around the world.
Syneos Health is a leading 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.
Syneos Health is an Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability or any other legally protected status and will not be discriminated against.
If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, including the use of this website, please contact us at: Email: ****** One of our staff members will work with you to provide alternate means to submit your application.
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