Regulatory & Compliance Support Consultant

1 month ago

Basking Ridge, United States Revolution Technologies Full time

Position Title: Regulatory & Compliance Support Consultant

Location: Basking Ridge, NJ (Mostly Remote)

  • This role has a Remote option, however, MUST be Local in the Area
  • Requires Onsite for at least 2 - 4 days per month (Can Fluctuate, but average of two days a month)
  • Must provide proof of local area location

Interview Mode: MS Teams Video Call

Approximate Duration: 12+ month contract


Mandatory skills:

  • Experience in pharmaceutical environment.
  • Experience in regulatory environment is required.
  • High level exposure or knowledge about FDA inspection and internal audit process.
  • Experience on Veeva RIM Submission/Archive, Publishing etc.


JD details :

  • Ensure compliance with company Standard Operating Procedures and regulatory agency regulations/guidance.
  • Represents Regulatory Affairs on cross-functional project teams.
  • Provide technical expertise to cross-functional teams on managing the lifecycle of submission-related documents.
  • Work with Veeva Submissions/Archive team, subject matter experts, and cross functional departments to support business needs.
  • Effectively communicate and work collaboratively with cross-functional teams, including regulatory affairs, clinical operations, and quality assurance & validation.
  • Gather and assemble information necessary for submissions in accordance with regulations/guidance.
  • Capable of reviewing documentation with a high degree of attention to detail. Proactive to identify issues and propose solutions, as necessary.
  • Conduct review of published submissions to ensure consistency and compliance with regulatory requirements.
  • Maintain knowledge of local and global regulatory submission requirements.
  • Maintain compliance with GxP, government regulations, industry standards, approved specifications, and Company procedures &directives.
  • Provide Regulatory Affairs support during internal and external audits and inspections.
  • Exposure in Change management process, requirement gathering, qualifying the changes etc.,
  • Actively participate in the development of Regulatory Operations processes like SOPs/GOPs, Work instructions, Checklist, templates etc.
  • Consistently support for regulatory systems access and change management.
  • Responsible for communicating business process improvements, business related issues, status updates or opportunities.


Qualifications:

  • Bachelors’ degree, preferably in a life science or a related field
  • 5 to 10 years of experience in pharmaceutical environment.
  • Experience in regulatory environment is required.
  • Excellent written, verbal communication and presentation skills.
  • High level exposure or knowledge about FDA inspection and internal audit process.
  • Knowledge or exposure on Veeva RIM Submission/Archive, Publishing etc.

  • Regulatory Support

    1 month ago

    Ridge, United States Axiom Software Solutions Limited Full time

    Job Title : Regulatory Support Location : Basking Ridge NJ Remote Option: Yes. But the candidate should be available to attend customer meetings twice in a month Mandatory skills: • experience in pharmaceutical environment. • Experience in regulatory environment is required. • High level exposure or knowledge about FDA...

  • Regulatory Support

    1 month ago

    Ridge, United States Magicforce Full time

    experience in pharmaceutical environment. Experience in regulatory environment is required. High level exposure or knowledge about FDA inspection and internal audit process. Knowledge or exposure on Veeva RIM Submission/Archive Publishing etc. Job Title: Consultant Qualifications: Bachelors degree preferably in a life science or a related field ...

  • Regulatory Support

    1 month ago

    Ridge, United States Magicforce Full time

    experiencein pharmaceuticalenvironment.Experiencein regulatory environment isrequired.Highlevel exposure or knowledge about FDA inspection and internal auditprocess.Knowledgeor exposure on Veeva RIM Submission/Archive Publishingetc. JobTitle:Consultant Qualifications:Bachelorsdegree preferably in a life science or a related field5to 10 years of experience...

  • Director, Global Regulatory Affairs

    4 weeks ago

    Basking Ridge, United States BioSpace, Inc. Full time

    Job Details Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise...

  • Associate Director, Global Regulatory Affairs Labeling

    4 weeks ago

    Basking Ridge, United States Daiichi Sankyo, Inc. Full time

    Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a...

  • Director, US Regulatory Affairs Strategy

    4 weeks ago

    Basking Ridge, United States BioSpace, Inc. Full time

    Job Details Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise...

  • Associate Director, US Regulatory Affairs Strategy

    4 weeks ago

    Basking Ridge, United States BioSpace, Inc. Full time

    Job Details Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise...

  • Associate Director, US Regulatory Affairs Strategy

    4 weeks ago

    Basking Ridge, United States Daiichi Sankyo, Inc. Full time

    Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a...

  • Senior Solution Architect/CTO- Pharma experience

    3 weeks ago

    Basking Ridge, United States JSR Tech Consulting Full time

    Role Overview As a Senior Solutions Architect or CTO at JSR, you will lead and shape digital transformation strategies across client engagements, particularly in healthcare and life sciences. This role demands a forward-thinking, strategic leader who can design and implement cutting-edge technology solutions-including Generative AI-while managing a team of...

  • Proposals Consultant

    2 weeks ago

    Basking Ridge, United States Verizon Communications, Inc. Full time

    The Project Specialist plays a crucial role in supporting our sales teams on customer driven questionnaires, ensuring an efficient process and accurate information. This entry-level position offers an opportunity to learn and grow within the Global B Proposal, Consultant, Project Management, Business Services

  • Manager, Regulatory Affairs

    3 weeks ago

    Basking Ridge, NJ, United States Daiichi Sankyo, Inc. Full time

    Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 125 years of scientific expertise and a...

  • Executive Director, Research QA

    4 weeks ago

    Basking Ridge, United States BioSpace, Inc. Full time

    Job Details Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise...

  • Senior Business Risk Consultant

    4 weeks ago

    Park Ridge, United States The LaSalle Group Full time

    LaSalle Network has partnered with a leading consulting firm looking to hire on a new Senior Business Risk Consultant to join their team in developing and implementing comprehensive risk management strategies for Fortune 500 clients. The ideal candidate will bring deep expertise in enterprise risk management, regulatory compliance and business continuity...

  • Director, Labeling

    4 weeks ago

    Basking Ridge, United States BioSpace, Inc. Full time

    Job Details Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise...

  • Director, Labeling

    4 weeks ago

    Basking Ridge, United States Daiichi Sankyo, Inc. Full time

    Join a Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a...

  • Veeva Solutions Architect

    3 weeks ago

    Basking Ridge, United States Futran Tech Solutions Pvt. Ltd. Full time

    Job Title: Veeva Solutions Architect Job Function: Solutions Architecture Job Type: W2 to G3 Tech Consultants (No other benefit than hourly rate) Only GC or Citizen Location: Basking Ridge, NJ 07920 (Hybrid- on site as required) Contract: 12 months Note: Candidate needs to Sign Non-Compete and agree to work with the contract duration. Scope of Job • The...

  • Board Certified Behavior Analyst BCBA Case Supervisor Position

    4 weeks ago

    Basking Ridge, New Jersey, United States Behavior Analysis and Support Services (BASS ABA) Full time

    Job Title: Board Certified Behavior Analyst BCBA Case SupervisorBehavior Analysis and Support Services (BASS ABA) is seeking a highly skilled Board Certified Behavior Analyst (BCBA) to serve as a Case Supervisor in our team. As a BCBA Case Supervisor, you will be responsible for overseeing the implementation of behavioral assessment measures, developing...

  • Associate Director, Global Regulatory Affairs Labeling

    3 weeks ago

    Basking Ridge, NJ, United States Daiichi Sankyo, Inc. Full time

    Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a...

  • Release Coordinator

    4 days ago

    Basking Ridge, United States Verizon Full time

    Must-haves: 5+ years of SDLC release management/coordinationExperience with Content related Releases – this team does many small releases every weekRelease management as it pertains to governance & complianceRetail experience, understanding fast paced environments, and ability to communicate well with teammates and leadershipDay-to-Day: This consultant...

  • Associate Director, Informatics

    3 weeks ago

    Basking Ridge, United States Daiichi Sankyo, Inc. Full time

    **Join a Legacy of Innovation 110 Years and Counting!**Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a...