Sr Regulatory Associate PM (US or LATAM Based Only)
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
**Fully Remote in US and LATAM Only. Must be eligible to work in US or LATAM without Visa sponsorship in order to be considered.
-Under limited supervision, performs detailed and confidential project-related duties directly related to regulatory submissions and regulatory compliance.
-May also perform limited general project administrative
duties.
-Responsibilities typically include creating and editing regulatory reports,
summarization of data in the public domain, conduct quality control review of documents, and may also include collection and analysis of data to produce reports to support investigational new drug applications(INDs), new drug applications or new marketing applications (NDAs/MAAs), drug master files (DMFs),
variations, renewals, marketing authorization transfers (MATs) and other lifecycle maintenance activities.
JOB RESPONSIBILITIES
Essential Functions:
For non-complex submissions, independently fulfill the following responsibilities. For complex submissions, fulfill the following responsibilities under supervision and with guidance from more senior regulatory colleagues:
-Prepares and submits full application or components of IND, marketing and lifecycle maintenance
applications to ensure compliance with government acts and regulations.
-Undertakes information processing activities with extremely high reliability at high quality and in tight timelines according to standard processes and operating procedures.
-Undertake project specific activities with minimal supervision from senior colleagues within cost and time estimates/contracts.
- Preparation of records and/or logs and maintenance or update of regulatory databases as per Syneos Health and/or client requirements.
-Conducts Quality Control reviews of documents and sends out for review, tracks until final submission or delivery to client.
-Attends client meetings as needed and builds client relationship in support of projects and deliverables.
-Systematically reviews Regulatory Associates or other Senior Associate's work, performance, and productivity tracking, coordinating with project manager and director for coordination of the project.
-Identifies risks to project delivery related to own workload and appropriate escalation. For identified non-complex issues, provide proposals for issue resolution.
- Assists in training and mentoring of team members depending upon project requirements.
Create and Maintain Content Plans within Veeva Vault RIM
Translating Smartsheet timelines into Microsoft Project and Veeva Vault RIM
Assist with planning, managing, and tracking of regulatory submissions
Qualifications - External
QUALIFICATION REQUIREMENTS:
3-5 years of Regulatory Experience within Industry
BS/BA degree or equivalent practical experience.
Experience in a work-related area preferred.
Excellent interpersonal / communication skills.
Advanced skills in Microsoft Office Applications.
Strong analytical skills.
Ability to work independently and to understand and carry out detailed instructions.
Ability to interact with staff from multiple departments.
Ability to work concurrently on projects, each with specific instructions that may differ from project to
project.
Fluent in speaking, writing, and reading English.
In-depth understanding of regulatory requirements and guidelines including FDA regulations, EMA guidelines and ICH standards. Keywords: eCTD, NDA, IND, EU CTA, MAA, EU CTR, NDS
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... For full info follow application link.
