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Regulatory Consultant US based 2-3 years of Submissions Project Management

Lifelancer
Bridgewater, NJ Full Time
POSTED ON 4/15/2025
AVAILABLE BEFORE 5/7/2025

Job Title : Regulatory Consultant US based 23 years of Submissions & Project Management

Job Location : United States

Job Location Type : Remote

Job Contract Type : Fulltime

Job Seniority Level : MidSenior level

Description

Regulatory Consultant US Submissions experience & Project Management experience required

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

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a FullService 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 accelerate the delivery of therapies because we are passionate to change lives.

Discover what our 29000 employees across 110 countries already 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 total rewards program.
  • We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally and we are dedicated to taking care of our people.
  • We are continuously building the company we all want to work for and our customers want to work with. Why Because when we bring together diversity of thoughts backgrounds cultures and perspectives – we’re able to create a place where everyone feels like they belong.

Job Responsibilities

For noncomplex and complex submissions independently fulfill the following responsibilities :

  • Create and Maintain Content Plans within Veeva Vault RIM
  • Translating Smartsheet timelines into Microsoft Project and Veeva Vault RIM
  • Assist with planning managing and tracking of regulatory submissions
  • Support Global Submission Managers with project management activities tasks and tracking
  • Assist with coordination and communication of regulatory submissions to Publishing
  • Ability to work with firm deadlines and adapt quickly to changing requirements and priorities.
  • Excellent organization written / verbal communication to explain difficult information and attention to detail.
  • Submission Technology : Proficiency in electronic submission tools and software such as eCTD and regulatory information management systems. Keywords : Insight Publisher Lorenz Publisher Veeva Vault RIM Content Planning eCTD Viewers DXC (ISI) Toolbox
  • Project Management Technology : Experience and proficiency with project management tools and software. Keywords : Smartsheet Microsoft Project Excel Office timeline Pro
  • Maintenance of individual training records (Syneos Health or client related) and completion of all designated required training.
  • Qualifications

    What we’re looking for

  • B.S. (or equivalent experience) and 5 years of Regulatory Affairs Work Experience with a focus on publishing and / or submissions
  • M.S. (or equivalent experience) and 3 years of Regulatory Affairs Work Experience with a focus on publishing and / or submissions
  • Indepth understanding of regulatory requirements and guidelines including FDA regulations EMA guidelines and ICH standards. Keywords : eCTD NDA IND EU CTA MAA EU CTR NDS
  • Strong analytical skills good attention to detail.
  • Ability to work concurrently on projects each with specific instructions that may differ from project to project.
  • Fluent in speaking writing and reading English.
  • 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 73000 Sites and 675000 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 everchanging 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.

    Lifelancer ( ) is a talenthiring platform in Life Sciences Pharma and IT. The platform connects talent with opportunities in pharma biotech health sciences healthtech and IT domains.

    For more details and to find similar roles please check out the below Lifelancer link.

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    Key Skills

    Law Enforcement,ABB,CMS,Information Technology Sales,Insurance Management,Client Services

    Employment Type : Full Time

    Vacancy : 1

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