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    Senior Regulatory Consultant (Eu Market Experience)

    Syneos Health
    2+ years
    Not Disclosed
    Remote
    10 Dec. 30, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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)
    Updated: December 18, 2024
    Location: India-Asia Pacific - IND-Home-Based, India
    Job ID: 24006532

    Job Description

    Senior Regulatory Consultant (EU Market Experience)

    Syneos Health® is a leading fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes that address modern market realities.

    Our Clinical Development model puts the customer and patient at the heart of everything we do. We’re continually looking for ways to simplify and streamline our operations to make Syneos Health easier to work with and a better place to work for.

    Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you will collaborate with passionate problem solvers and innovators to help our customers achieve their goals. We are agile, driven, and committed to accelerating the delivery of therapies because we are passionate about changing lives.

    Discover why our 29,000 employees across 110 countries 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 a comprehensive rewards program. Our Total Self culture unites us globally, fostering authenticity and creating a place where everyone feels like they belong.

    Job Responsibilities

    • Independently manage both non-complex and complex submissions, ensuring alignment with global or regional regulatory requirements.
    • Conduct research on existing product data to prepare gap analyses, product development plans, and regulatory submissions.
    • Contribute to or prepare administrative and technical components of regulatory agency submissions, including IND, pre-approval submission packages, product registration applications, and post-approval maintenance.
    • Prepare briefing packages for regulatory agency meetings or scientific advice and actively support agency interactions.
    • Manage day-to-day regulatory activities for assigned projects, ensuring timely delivery, adherence to budget, and alignment with project strategies.
    • Serve as regulatory support on multidisciplinary project teams, working alongside clinical and technical experts to develop products throughout their lifecycle.
    • Act as a subject matter expert, providing day-to-day troubleshooting and presenting solutions to project-related issues.
    • Prepare estimates for regulatory services as part of single or multiple service proposals.
    • Support meetings with clients to discuss proposals, project status, and business development activities.
    • Ensure compliance with global regulatory requirements and Syneos Health’s policies and processes.
    • Prepare training materials and share best practices internally and externally.
    • Participate as regulatory support in internal or external project audits and cross-functional initiatives.
    • Contribute to the creation and maintenance of SOPs and other process-related documentation.
    • Support oversight of team members in executing their project responsibilities, ensuring additional guidance when necessary.
    • Maintain training records and complete required training in a timely manner.

    Qualifications

    What We’re Looking For:

    • Minimum of 5 years of experience in CMC authoring and reviewing (specifically Module 3).
    • EU market experience is required.
    • BS or PhD degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing.
    • Experience contributing to regulatory submissions, including IND, PMA, NDA, MAA, and CTD (including electronic submissions).
    • Excellent interpersonal and communication skills, both written and verbal.
    • Strong customer service skills and the ability to work effectively as part of a team or independently.
    • Good quality management skills.
    • Advanced proficiency in Microsoft Office applications.
    • Ability to interact with staff across multiple departments to establish project standards.
    • Strong initiative, adaptability, and proactivity.
    • Analytical skills with strong attention to detail.
    • Ability to manage multiple projects, each with different instructions.
    • Fluency in English, both written and spoken.

    Get to Know Syneos Health

    Over the past five years, Syneos Health has worked with 94% of all Novel FDA-approved drugs, 95% of EMA-authorized products, and conducted over 200 studies across 73,000 sites with 675,000+ trial patients.

    We encourage initiative and challenge the status quo in a highly competitive, ever-evolving environment. Learn more about Syneos Health and the difference we’re making in the world of biopharmaceuticals.

    Additional Information

    The tasks, duties, and responsibilities listed in this job description are not exhaustive. The company may, at its discretion, assign other tasks or responsibilities. Equivalent experience, skills, and/or education will also be considered. All job descriptions are intended to comply with applicable legislation and promote equal opportunities in recruitment and employment practices.

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