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Regulatory Consultant Cmc

hace 2 semanas

Bogotá, Colombia Syneos - Clinical and Corporate - Prod A tiempo completo

**Description**

Regulatory Consultant CMC - Biologics

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.

**Responsibilities**

  • Previous CMC with Biologics is required
  • Veeva Vault RIM experience is required
  • Open to NA and LATAM - must work EST hours.

For non-complex and complex submissions, independently fulfill the following responsibilities:

  • Conduct research of existing product data relative to global or regional regulatory requirements for the preparation of gap analyses, product development plans, and other regulatory submissions.
  • Manage and/or operationalize the delivery of day-today 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.
  • 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.
  • Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training.

At Syneos 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.

Salary Range

**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. Learn more about Syneos Health.

**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