Description

Senior Regulatory Associate (CMC - EU,APAC, gulf countries.)

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

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 deliver - for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

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 building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life.
. We are continuously building the company we all want to work for and our customers want to work with. Why Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

.

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.
Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training.

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 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.

Summary

Job Description Summary 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 authorisation transfers (MATs) and other lifecycle maintenance activities