job title: regulatory associate (syneos)

Job Responsibilities

• Minimum 1 year of experience in Global Regulatory Affairs.

• Hands-on experience in the preparation and review of global CMC dossiers, variation applications, and post-approval changes.

• Solid understanding of regulatory markets and authorization dossier applications across regions including: EU, US, LATAM, APAC, Middle East, Africa, and China.

• Proven ability to work effectively in a fast-paced, team-oriented environment.

• Strong aptitude and attitude to learn and grow within the regulatory domain.

• Candidates with internship experience in Regulatory Affairs (CMC) will be given preference.

• ​Assists with preparation of product development documents including gap analyses and clinical development plans.

• ​Assists with preparation of regulatory submission documents including components of 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, according to current government regulations and guidelines.

• ​Conducts regulatory research to identify regulatory precedents and to support the preparation of orphan drug designation requests.

• ​Performs quality checks on related documents.

• ​Assists with submissions of other regulatory documents and other regulatory research as needed.

• ​Assists clients, customers, or others with general information

• ​Gathers, compiles, analyzes, and reports information.

• ​Gathers information, searches files and records, and makes personal contacts to obtain specific information in order to prepare detailed reports and compose routine correspondence.

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​QUALIFICATION REQUIREMENTS: ​

• ​Masters in Pharmacy (Preferred)or Masters in science/healthcare field, or equivalent combination of education and experience.

• ​Excellent interpersonal / communication skills.

• ​Advanced skills in Microsoft Office Applications.

• ​Good time and project management skills, preferred.

• ​Strong analytical skills and attention to detail.

• ​Ability to work both as a team member and 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 preferred.

• ​Fluent in speaking, writing, and reading English.