Associate Regulatory Affairs

4 weeks ago

Thousand Oaks, United States Aditi Consulting Full time
Responsibilities:
  • Maintain Regulatory document management and tracking systems
  • Create/archive Clinical Trial and Marketing Application submissions/Health Authority correspondence
  • Responsible for maintaining the on-site US Certificate of Pharmaceutical Product (CPP) responsibilities, as well as hard copy pickup at company and mailings.
  • Point of contact between Regulatory Representatives/CMC and publishing teams
  • Ensuring Regulatory compliance with SOPs and Regulatory authorities
  • Provide support to RDA team members and other functional areas, including vendors
  • Collaboration with external partners/outsourced CROs
  • Responsible for creating, running, and analyzing report data for potential Veeva RIM system clean-up

Top 3 Must Have Skill Sets:
  • Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance, including familiarity with US Certificate of Pharmaceutical Product (CPP) process.
  • Basic understanding of the Veeva RIM Vault system
  • Good written and verbal communication skills
  • Independent time management and prioritization skills and detail oriented
  • Critical thinking skills

Requirements:
  • Works well collaboratively, as there is a lot of teamwork involved in what we do.
  • Detail oriented, to be able to monitor data quality.
  • Comfortable learning new systems/processes. Someone who is able to follow instructions/guides, since we work in a framework based on rules/compliance.
  • Education background preferred for this role:
  • Science/Technology-based degrees are preferred OR industry-specific experience.
  • If the candidate has experience in performing our team's tasks and would be able to do this job, the type of degree would not necessarily matter.
  • Top 3 qualities of the hiring manager's ideal candidate:
  • Good communication skills (verbal & written), resourceful critical thinker, detailed.
  • (Overall, we'd need someone who understands the importance of details, since we work so much with monitoring Data Quality and someone who is able to communicate clearly with internal and external teams.
  • Once training is completed, this individual must then understand how to utilize the tools provided to complete needed tasks, which requires resourcefulness and critical thinking skills.)


Compensation:
The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate's qualifications, skills, competencies, competencies, experience, location and end client requirements).

Benefits and Ancillaries:
Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.

  • Senior Manufacturing Associate

    13 hours ago

    Thousand Oaks, United States Astrix Full time

    Our client, a renowned leader in the field of biotechnology, is revolutionizing the use of living cells to create groundbreaking biologic medicines. As a guiding force in the biotech industry, they set the bar for innovation and advancement. We are excited to announce a fantastic opportunity to join the team as a Sr. Manufacturing Associate We are seeking a...

  • Senior Manufacturing Associate

    18 hours ago

    Thousand Oaks, United States Astrix Full time

    Our client, a renowned leader in the field of biotechnology, is revolutionizing the use of living cells to create groundbreaking biologic medicines. As a guiding force in the biotech industry, they set the bar for innovation and advancement. We are excited to announce a fantastic opportunity to join the team as a Sr. Manufacturing Associate We are seeking a...

  • Regulatory Writing Mgr

    4 weeks ago

    Thousand Oaks, United States Aditi Consulting Full time

    Responsibilities: Write or lead all aspects of the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phases 1-4) Write CTD sections including the Summary of Clinical Efficacy, Summary of Clinical Safety, Summary of Clinical Pharmacology, Summary of Biopharmaceutics, Clinical Overview, Table of...

  • Quality Assurance Manager

    2 days ago

    Thousand Oaks, United States Accordance Search Group Full time

    Responsibilities Manage the Quality Affairs team Develop/improve/maintain processes and procedures to ensure the most robust product designs and product quality is consistently manufactured. Ensure timely and robust incoming inspection; partner with suppliers to drive quality improvements. Develop strong partnerships with R&D, manufacturing, marketing,...

  • Quality Assurance Manager

    3 days ago

    Thousand Oaks, United States Accordance Search Group Full time

    ResponsibilitiesManage the Quality Affairs teamDevelop/improve/maintain processes and procedures to ensure the most robust product designs and product quality is consistently manufactured. Ensure timely and robust incoming inspection; partner with suppliers to drive quality improvements. Develop strong partnerships with R&D, manufacturing, marketing, sales...

  • Quality Assurance Manager

    3 days ago

    Thousand Oaks, United States Accordance Search Group Full time

    ResponsibilitiesManage the Quality Affairs teamDevelop/improve/maintain processes and procedures to ensure the most robust product designs and product quality is consistently manufactured. Ensure timely and robust incoming inspection; partner with suppliers to drive quality improvements. Develop strong partnerships with R&D, manufacturing, marketing, sales...

  • Quality Assurance Manager

    18 hours ago

    Thousand Oaks, United States Accordance Search Group Full time

    Responsibilities Manage the Quality Affairs team Develop/improve/maintain processes and procedures to ensure the most robust product designs and product quality is consistently manufactured. Ensure timely and robust incoming inspection; partner with suppliers to drive quality improvements. Develop strong partnerships with R&D, manufacturing, marketing,...

  • Supply Chain Sr. Associate

    1 week ago

    Thousand Oaks, United States Donatech Full time

    Position would require the candidate to be a W2 employee of Donatech. US Citizenship/Permanent Resident Required. Support business processes related to NA-TO Back Office and process improvements with minimum supervision Act as a team lead or -member in cross functional projects Provide appropriate and accurate information and analysis for effective decision...

  • Supply Chain Sr. Associate

    1 week ago

    Thousand Oaks, United States Donatech Full time

    Position would require the candidate to be a W2 employee of Donatech. US Citizenship/Permanent Resident Required. Support business processes related to NA-TO Back Office and process improvements with minimum supervision Act as a team lead or -member in cross functional projects Provide appropriate and accurate information and analysis for effective decision...

  • Supply Chain Sr. Associate

    1 week ago

    Thousand Oaks, United States Ampcus Full time

    Fully Remote - Flexible hours Ideal Candidate: 3+ years of experience in a supply chain role, previous employment, strong knowledge of SAP, GMP/ GDP experience, and standard operation procedures (SOP) experience. Accountabilities Support business processes related to NA-TO Back Office and process improvements with minimum supervision Act as a team lead or...

  • Supply Chain Sr. Associate

    1 week ago

    Thousand Oaks, United States Aequor Technologies Full time

    Fully Remote - Flexible hours Ideal Candidate: 3+ years of experience in a supply chain role, previous *** employment, strong knowledge of SAP, GMP/ GDP experience, and standard operation procedures (SOP) experience. Accountabilities Support business processes related to NA-TO Back Office and process improvements with minimum supervision Act as a team lead...

  • Supply Chain Sr. Associate

    1 week ago

    Thousand Oaks, United States Ampcus Full time

    Fully Remote - Flexible hours Ideal Candidate: 3+ years of experience in a supply chain role, previous employment, strong knowledge of SAP, GMP/ GDP experience, and standard operation procedures (SOP) experience. Accountabilities Support business processes related to NA-TO Back Office and process improvements with minimum supervision Act as a team lead or...

  • Supply Chain Sr. Associate

    1 week ago

    Thousand Oaks, United States Aequor Technologies Full time

    Fully Remote - Flexible hours Ideal Candidate: 3+ years of experience in a supply chain role, previous *** employment, strong knowledge of SAP, GMP/ GDP experience, and standard operation procedures (SOP) experience. Accountabilities Support business processes related to NA-TO Back Office and process improvements with minimum supervision Act as a team lead...

  • Quality Control Associate, Microbiology

    1 month ago

    Thousand Oaks, United States FUJIFILM Diosynth Biotechnologies Full time

    The QC Associate, Microbiology is responsible for partnering with management in supporting and maintaining QC microbiological functions for new and existing GMP manufacturing operations. This position will also support facility qualification operations for new GMP manufacturing areas including Environmental Monitoring Performance Qualification (EMPQ) and GMP...

  • Quality Control Associate, Microbiology

    4 weeks ago

    Thousand Oaks, United States FUJIFILM Diosynth Biotechnologies Full time

    The QC Associate, Microbiology is responsible for partnering with management in supporting and maintaining QC microbiological functions for new and existing GMP manufacturing operations. This position will also support facility qualification operations for new GMP manufacturing areas including Environmental Monitoring Performance Qualification (EMPQ) and GMP...

  • Sr Associate IS Prog Analyst

    2 weeks ago

    Thousand Oaks, United States Aditi Consulting Full time

    Summary: This role employs entry level programming and design techniques that ensure adherence to software development standards, performance efficiency, reliable and maintainable code, and self-documenting programs. Must have a basic understanding of application development methodologies and techniques. Drafts and updates detailed project plans for small...

  • Supply Chain Sr. Associate

    1 week ago

    Thousand Oaks, United States ADVANCED BIO-LOGIC SOLUTIONS Full time

    Description: Note: Fully Remote - Flexible hours Ideal candidate: 3+ years of experience in a supply chain role, previous employment, strong knowledge of SAP, GMP/ GDP experience, and standard operation procedures (SOP) experience. Accountabilities ?Support business processes related to NA-TO Back Office and process improvements with minimum supervision?...

  • Sr Associate

    4 weeks ago

    Thousand Oaks, United States Collabera Full time

    Job DescriptionJob DescriptionDescription:Lab based position, analytical and processing work lots of varibility. not a routine postiion lost of documentation, lab reports, computer skills is a must, microsoft, data analysis. communication skills, comfortable with technical writing. lots of teamwork with 7-8 supports the entire department. very driven and...

  • Synthetics Principal Product Quality Leader

    7 days ago

    Thousand Oaks, United States Amgen Full time

    **HOW MIGHT YOU DEFY IMAGINATION?** If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering...

  • Scientist Senior Associate

    4 weeks ago

    Thousand Oaks, United States Collabera Full time

    Job DescriptionJob DescriptionDescription: Bachelors in Analytical chemistry.Top 3 Must Have Skill Sets:1. Degree in r Analytical Chemistry; experience in a Biopharmaceutical working environment2. HPLC method Development3. GC, GC-MS and KF Analyseshighly desired: 2 years industry outside of collegeJob Details:Bachelors' degree & 2-3 YOETo perform...