Senior Regulatory Consultant (Eu Market Experience)

5+ years

Not Disclosed

Remote

10 Dec. 24, 2024

Job Description

Job Type: Full Time Education: BS/PhD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Regulatory Consultant (EU Market Experience)
Syneos Health® Overview
Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success. By leveraging unique clinical, medical affairs, and commercial insights, we aim to address the challenges of the modern healthcare landscape. Our Clinical Development model prioritizes the customer and the patient at the center of everything we do. We are continuously improving our processes to make Syneos Health easier to work with and an even better place to work.

Whether in a Functional Service Provider partnership or a Full-Service environment, our employees collaborate as passionate problem-solvers, working as a team to drive innovation and deliver successful therapeutic solutions. At Syneos Health, we are driven to make a difference because we believe in changing lives.

Why Syneos Health?

Growth and Development: We are passionate about developing our people through career progression, supportive management, technical and therapeutic training, and recognition programs.
Total Self Culture: Syneos Health fosters an inclusive environment where employees can be their authentic selves. Our diversity and unity drive our success as we work together to meet the needs of our customers.
Global Impact: Syneos Health’s global team of 29,000 employees across 110 countries drives meaningful change in healthcare. By bringing together diverse thoughts, perspectives, and expertise, we create a sense of belonging and support for all.

Job Responsibilities:

As a Senior Regulatory Consultant at Syneos Health, you will:

Regulatory Submissions & Gap Analysis: Conduct research on existing product data to prepare gap analyses, product development plans, and other regulatory submissions, focusing on both non-complex and complex regulatory requirements.
Submission Preparation: Contribute to the preparation of INDs, pre-approval submission packages, product registration applications, and post-approval maintenance submissions. Prepare briefing materials for regulatory agency meetings and support interactions with agencies.
Project Management & Compliance: Manage and operationalize regulatory activities for assigned projects, ensuring timelines, scope, and budgets are adhered to. Ensure compliance with global regulatory requirements and Syneos Health policies.
Team Support: Act as a subject matter expert to troubleshoot project-related issues and provide guidance to multidisciplinary teams. Offer insights on regulatory practices and standards, and assist in proposal preparation for regulatory services.
Training & Development: Develop training materials and share best practices for regulatory activities internally and externally. Contribute to the creation and maintenance of SOPs and other process-related documents.
Cross-Functional Support: Participate in project audits, cross-functional initiatives, and provide support in managing project responsibilities.

What We’re Looking For:

Experience: A minimum of 5 years of experience in CMC authoring and reviewing (specifically Module 3), with a strong focus on the EU market.
Educational Background: A BS or PhD degree in a science-related field, or equivalent experience in regulatory, medical writing, or a related discipline.
Regulatory Experience: Strong experience in preparing regulatory submissions such as INDs, PMAs, NDAs, MAAs, CTDs, and electronic submissions.
Skills:
- Proficiency in Microsoft Office applications and excellent communication skills (both written and verbal).
- Strong analytical abilities with attention to detail and the ability to handle multiple projects concurrently.
- Strong customer service skills, with the ability to work independently and in a team.
- Proactive, adaptable, and able to take initiative in a fast-paced environment.
Language Proficiency: Fluency in English (written and spoken) is required.

Syneos Health’s Global Impact:

Industry Leadership: Over the last 5 years, Syneos Health has worked on 94% of all Novel FDA-approved drugs and 95% of EMA-authorized products.
Global Reach: We have contributed to more than 200 studies across 73,000 sites, with over 675,000 trial patients globally.

Additional Information:
Syneos Health may assign additional tasks and responsibilities beyond those outlined in the job description. Equivalent experience, skills, or education will be considered. The company is committed to providing a diverse and inclusive work environment, in compliance with all relevant employment laws and the Americans with Disabilities Act. Reasonable accommodations will be provided as necessary to assist employees in performing their duties.

Join Syneos Health and be part of a global team that’s transforming the future of healthcare.

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Senior Regulatory Consultant (Eu Market Experience)

Job Description

Why Syneos Health?

Job Responsibilities:

What We’re Looking For:

Syneos Health’s Global Impact:

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