Current jobs related to Regulatory Affairs Specialist - Somerville New Jersey - VCLS

  • Regulatory Affairs Specialist

    4 days ago

    Somerville, New Jersey, United States Fladger Assoc. Inc. Full time

    Job Title: Regulatory Affairs SpecialistJob Summary:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Fladger Assoc. Inc. The ideal candidate will have a strong background in regulatory affairs, with experience working on medical device projects.Responsibilities:Represent Regulatory Affairs by attending project team meetings,...

  • Regulatory Affairs Specialist

    4 days ago

    Somerville, New Jersey, United States Fladger Assoc. Inc. Full time

    Job DescriptionFladger Assoc. Inc. is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our project team, you will be responsible for ensuring compliance with regulatory requirements for medical devices.Key Responsibilities:Represent Regulatory Affairs by attending project team meetings, providing regulatory...

  • Regulatory Affairs Specialist

    4 weeks ago

    New York, New York, United States Oscar Health Full time

    Job Title: Regulatory Affairs SpecialistOscar Health is seeking a highly skilled Regulatory Affairs Specialist to join our Regulatory Legal & Government Affairs team.About the RoleThe Regulatory Affairs Specialist will play a critical role in ensuring that Oscar Health complies with all relevant state and federal regulations. This includes tracking and...

  • Regulatory Affairs Specialist

    4 weeks ago

    New York, New York, United States SPCSHP Full time

    Job Title: Senior Specialist, Regulatory AffairsAbout the Role:We are seeking a highly skilled Senior Specialist, Regulatory Affairs to join our team at SPCSHP. As a key member of our Regulatory Affairs team, you will be responsible for managing all legal and regulatory submissions related to healthcare and pharmaceutical advertising campaigns.Key...

  • Regulatory Affairs Specialist

    3 weeks ago

    New York, New York, United States Intellectt Inc Full time

    Job Description:At Intellectt Inc, we are seeking an experienced Regulatory Affairs Specialist to join our team. The ideal candidate will have a strong background in managing regulatory processes for medical devices or pharmaceuticals.Key Responsibilities:Prepare, review, and submit regulatory documents to regulatory authorities to support product...

  • Regulatory Affairs Specialist

    3 days ago

    Somerville, Massachusetts, United States VCLS Full time

    Unlock Your Potential as a Regulatory ScientistVCLS is a dynamic team dedicated to providing exceptional support for our clients' regulatory needs. As a Regulatory Scientist, you will play a crucial role in shaping the future of life-changing therapies.Key Responsibilities:Develop and implement regulatory strategies for the development of new drugs and/or...

  • Senior Regulatory Affairs Specialist

    3 weeks ago

    New York, New York, United States Stryker Full time

    Senior Staff Regulatory Affairs SpecialistWe are seeking a highly skilled Senior Staff Regulatory Affairs Specialist to join our Joint Replacement Division based in Weston, FL or Mahwah, NJ.About the RoleThis is a key position that will support Stryker's Joint Replacement Robotics and Digital medical device hardware and software new product development and...

  • Regulatory Affairs Specialist

    4 weeks ago

    New York, New York, United States Randstad Life Sciences US Full time

    Randstad Life Sciences US is seeking a Senior Regulatory Affairs Consultant with 10-15 years of experience to join their dedicated Regulatory Affairs team. This role is pivotal in ensuring that the company's innovative products navigate the complex regulatory landscape efficiently and remain compliant with global regulatory requirements. The ideal candidate...

  • Regulatory Affairs Specialist

    4 weeks ago

    New York, New York, United States Barrington James Full time

    Senior Regulatory Associate - Hybrid, NJ (2-3 days a week)Barrington James is partnering with a global commercial pharmaceutical company that is passionate about bringing generic drugs to market across multiple formulations and dosage forms. They are seeking an Associate Manager or Manager to join their team in a hybrid role based in New Jersey (2-3 days a...

  • Senior Regulatory Affairs Specialist

    4 days ago

    New York, New York, United States Synchron LLC Full time

    About SynchronSynchron is a clinical-stage endovascular brain computer interface (BCI) company. Our mission is to develop a first-in-class commercial BCI for more than 100 million people worldwide with upper limb impairment. We are committed to bringing life-changing technologies to people.Job Title: Senior Regulatory Affairs SpecialistThe Senior Regulatory...

  • Regulatory Affairs Director

    4 days ago

    Jersey City, New Jersey, United States Mitsubishi Chemical Group Full time

    Job Summary:Mitsubishi Tanabe Pharma America, Inc. is seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory affairs department, you will be responsible for providing strategic global regulatory guidance to cross-functional project teams responsible for product development.Key Responsibilities:Develop and...

  • Regulatory Affairs Director

    2 weeks ago

    Jersey City, New Jersey, United States Mitsubishi Chemical Group Full time

    Job Title: Director, Regulatory Affairs (Early Development)Mitsubishi Tanabe Pharma America, Inc. is seeking a highly skilled Director, Regulatory Affairs (Early Development) to join our team. As a key member of our regulatory affairs department, you will be responsible for providing strategic global regulatory guidance to cross-functional project teams...

  • Head of Regulatory Affairs

    4 weeks ago

    Jersey City, New Jersey, United States Fairway Consulting Group Full time

    Regulatory Affairs ProfessionalFairway Consulting Group is seeking a highly skilled Regulatory Affairs professional to join our team. As a key member of our team, you will be responsible for developing and implementing regulatory strategies that align with business objectives, ensuring compliance with global regulations while driving sustainable growth and...

  • Head of Regulatory Affairs

    2 weeks ago

    Jersey City, New Jersey, United States Fairway Consulting Group Full time

    Job Title: Head of Regulatory AffairsOur client, a rapidly growing clinical-stage biotechnology company, is seeking a seasoned professional to lead their Regulatory Affairs team. As Head of Regulatory Affairs, you will be responsible for developing and implementing regulatory strategies that align with corporate goals and ensure compliance with global...

  • Regulatory Affairs Specialist

    3 days ago

    New York, New York, United States Synchron LLC Full time

    Regulatory Affairs SpecialistSynchron LLC is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for planning and executing regulatory submissions and ensuring regulatory compliance.Key Responsibilities:Provide regulatory strategy and guidance on medical devices throughout...

  • Principal Regulatory Affairs Specialist

    2 weeks ago

    New Bedford, Massachusetts, United States Werfen Full time

    Job SummaryThe Principal Regulatory Specialist is responsible for ensuring compliance with regulatory requirements for software as a medical device (SaMD) products. This role involves developing and executing regulatory strategies, preparing regulatory plans and submissions, and collaborating with cross-functional teams to ensure regulatory compliance.Key...

  • Regulatory Affairs Specialist

    2 weeks ago

    New York, New York, United States Oscar Health Full time

    Job SummaryOscar Health is seeking a highly skilled Attorney to join our Regulatory Legal & Government Affairs team. As a key contributor to the development of our state and legal department, you will leverage your expertise in state legislative and regulatory processes to drive business growth and ensure compliance with industry regulations.Key...

  • Regulatory Affairs Specialist

    4 days ago

    New Providence, New Jersey, United States Globus Medical Full time

    Job Summary:The Regulatory Specialist at Globus Medical is responsible for drafting, submitting, and gaining clearance for 510(k) submissions and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products.This role entails developing FDA submissions, requiring working knowledge of products under review and...

  • Regulatory Affairs Manager

    3 weeks ago

    New York, New York, United States Willson International Limited Full time

    Job Title: Regulatory Affairs ManagerWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Willson International Limited. As a key member of our organization, you will be responsible for managing provisions of broker regulations set forth in 19 CFR 111 and various participating government agencies to ensure requirements are met or...

  • Medical and Regulatory Affairs Specialist

    2 weeks ago

    Jersey City, New Jersey, United States Omni Inclusive Full time

    Job SummaryWe are seeking a highly skilled Medical and Regulatory Affairs professional to join our team at Omni Inclusive. The successful candidate will be responsible for managing daily operations of MI vendors, navigating matrix partnerships, and ensuring accurate resources are available to execute on stakeholder needs.Key ResponsibilitiesManage daily...

Regulatory Affairs Specialist

2 months ago

Somerville New Jersey, United States VCLS Full time

About VCLS
Are you a dedicated regulatory professional looking to impact the healthcare sector? At VCLS (formerly B&H Consulting Services), we pride ourselves on delivering outstanding support for our clients' regulatory requirements.

Our Services:
We provide a full range of services, from developing effective regulatory strategies to managing electronic submissions and coaching clients for successful interactions with regulatory bodies.

The Opportunity:
As a Regulatory Scientist, you will play a crucial role in influencing the future of transformative therapies. This hybrid position allows for both in-office and remote work, promoting a collaborative atmosphere while ensuring a balanced work-life experience.

Key Responsibilities:

  • Regulatory Strategy: Collaborate with domestic and international clients to formulate and execute regulatory and CMC strategies for the development of new pharmaceuticals and combination products.
  • Regulatory Submissions: Prepare and evaluate regulatory documents to meet the highest standards, assembling dossiers for FDA and global submissions.
  • Consulting and Client Success: Guide clients on regulatory strategies and submissions in accordance with the latest guidelines from regulatory agencies.
  • Project Management: Oversee multiple projects, ensuring clear communication and adherence to timelines.
  • Collaboration: Benefit from mentorship by senior regulatory experts and work closely with our document management team to achieve exceptional outcomes.

Who You Are:

  • Proven Expertise: A committed regulatory affairs professional with a strong background in eCTD submissions and a comprehensive understanding of health authority regulations.
  • Education: A degree in Regulatory Sciences or Life Sciences.
  • Values: Uphold our core values of People, Innovation, Passion, and Excellence.
  • Detail-Oriented: Possess a keen eye for detail and exceptional organizational abilities.
  • Team Player: Excel in a collaborative setting and demonstrate outstanding communication skills.

Preferred Qualifications:
RAC certification and/or an advanced degree in a relevant field. Experience in a consulting environment and familiarity with eDRLS submissions are advantageous.

Why VCLS:

  • Make a Difference: Play a vital role in the development of life-saving therapies.
  • Learn and Grow: Collaborate with industry veterans and gain invaluable insights.
  • Hybrid Flexibility: Enjoy a work-life balance that empowers you.
  • Dynamic Environment: Be part of a passionate team focused on client success and innovation.
  • Growth Potential: Advance your career in a company that encourages continuous learning and development.

VCLS is committed to creating a diverse and inclusive workplace. We are an equal opportunity employer and value the unique contributions of all individuals.