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    Senior Regulatory Consultant (Eu Market Experience)

    Syneos Health
    5+ years
    Not Disclosed
    Remote
    10 Dec. 22, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/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

    Job Title: Senior Regulatory Consultant (EU Market Experience)
    Company: Syneos Health®

    About Syneos Health
    Syneos Health is a fully integrated global biopharmaceutical solutions organization that accelerates customer success by delivering unique clinical, medical, and commercial insights. We are committed to simplifying and streamlining processes to enhance collaboration and help bring therapies to market faster, all while keeping patients at the center of everything we do.

    Whether working in a Functional Service Provider partnership or a Full-Service environment, Syneos Health thrives on innovation, agility, and collaboration, with a mission to change lives.

    Why Syneos Health?

    • Career Development: We offer robust opportunities for career growth through ongoing training, development, and recognition.
    • Inclusive Culture: Our Total Self culture promotes authenticity and inclusion, creating a workplace where diversity is celebrated and everyone belongs.
    • Global Impact: Join a global workforce of 29,000 employees across 110 countries, making a tangible difference in the lives of patients around the world.

    Key Responsibilities:

    • Regulatory Submissions: Conduct research and contribute to the preparation of gap analyses, product development plans, and regulatory submissions for IND, MAA, PMA, NDA, and CTD, including electronic submissions.
    • Project Management: Lead and operationalize regulatory activities for assigned projects, ensuring adherence to timelines, budgets, and strategies.
    • Multidisciplinary Collaboration: Serve as regulatory support on multidisciplinary teams, including clinical and technical experts, to guide products through their life cycle.
    • Client Engagement: Prepare estimates, contribute to proposals, and engage with clients to discuss project statuses and future opportunities.
    • Regulatory Support: Provide expertise to troubleshoot project challenges, ensure compliance with global regulatory requirements, and support regulatory meetings and audits.
    • Training & SOP Development: Prepare training materials, contribute to best practice sharing, and support SOP creation or maintenance.
    • Team Leadership: Guide and mentor junior team members, ensuring they are equipped to fulfill project responsibilities effectively.

    Qualifications:

    • Experience: Minimum 5 years of experience in CMC authoring and reviewing (specifically Module 3) with EU market experience.
    • Education: BS or PhD in a science-related field or equivalent experience in regulatory/medical writing.
    • Regulatory Expertise: Proven experience with regulatory submissions including IND, NDA, MAA, PMA, and CTD.
    • Skills:
      • Strong communication skills, both written and verbal, including customer service skills.
      • Ability to interact effectively across departments and establish project standards.
      • Excellent analytical skills and attention to detail, with the ability to manage multiple projects concurrently.
      • Advanced proficiency in Microsoft Office Suite.
      • Ability to work independently and as part of a team in a dynamic, fast-paced environment.
    • Languages: Fluent in English (written and spoken).

    Get to Know Syneos Health
    Over the past 5 years, Syneos Health has worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and supported over 200 studies across 73,000 sites, with more than 675,000 trial patients.

    No matter your role, you'll be part of a team that challenges the status quo, drives change, and accelerates innovation in the biopharmaceutical industry.

    Additional Information:
    The duties and responsibilities outlined in this description are not exhaustive and may be subject to change. Syneos Health reserves the right to adjust tasks and responsibilities based on business needs. Equivalent experience, skills, or education may be considered in lieu of specific qualifications. The company is committed to compliance with the Americans with Disabilities Act, including providing reasonable accommodations when necessary.

    Apply today and be a part of the Syneos Health team, where your contributions will make a global impact!

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