4 Open Positions


Regulatory Director

FULL-TIME
PETALUMA, CALIFORNIA

DESCRIPTION

FULL-TIME
WORK REMOTELY

DESCRIPTION

Regulatory representation and leadership to cross-functional product development teams, development of regulatory strategies and support for clinical and non-clinical development programs and marketing applications. 

Responsible for project timelines and management of 510K, PMA, IND, NDA and global regulatory submissions. 

Lead regulatory activities including planning and reviewing of CMC, clinical and nonclinical sections of regulatory submissions. 

Plan, direct and prepare regulatory submissions (IND, NDA, IDE, 510(k), PMA) to ensure compliance with FDA and international regulations and guidelines. 

Develop and maintain SOPs with an emphasis on drug and device regulations. 

Perform research regarding regulatory strategic recommendations, and new and revised governmental regulations. 

Conduct successful negotiations and interactions with domestic and foreign regulatory agencies on assigned projects. 

Provide regulatory guidance with regard to preparation, review and approval of labeling and promotional materials. 

Prepare and assist with applicable regulatory audits. 

Statistical techniques.  


EDUCATION REQUIREMENTS:  

Minimum of B.S. in life sciences, engineering, or equivalent required. 

Advanced degree preferred. 

EXPERIENCE REQUIREMENTS: 

Minimum 5-7 years of experience in regulatory affairs for pharmaceutical and medical device biopharmaceutical companies. 

Experience with successful FDA and international agency negotiations and audits. 

Experience in developing and submitting successful 510(k), PMA/IND/NDA submissions with a thorough understanding of the drug and device development processes, FDA regulations and ICH guidelines. 

Excellent verbal and written communication skills. 


OTHER QUALIFICATIONS: 

Detail oriented with well-developed organizational and analytical skills. 

Experience with submitting documents in CTD and eCTD format. 

Suited to working in a fast-paced, small company environment. 


Regulatory Specialist

FULL-TIME
PETALUMA, CALIFORNIA

DESCRIPTION

This position reports to the Director of Regulatory Affairs and supports regulatory activities by complying with GMP/QSR, and EPA requirements. The Regulatory Specialist is responsible for maintaining establishment registration, annual licenses, product listing, and CFG in addition to the following duties:

  • Provides leadership in evaluating, reviewing, analyzing and timely reporting of product complaints to agencies based on regulatory requirements (post market surveillance). 
  • Reviews and assesses product/process changes for regulatory impact (Impact Assessment). 
  • Identifies product labeling requirements and provides regulatory support for the development of labels, promotional and advertising materials. 
  • Performs research on regulations, standards and regulatory pathways as needed. 
  • Develops regulatory procedures and supports quality related activities as necessary. 
  • Assists in pre-audit activities for preparedness and provides support for internal/external audits. 
  • Prepares regulatory submission documents and change notifications.

EDUCATION REQUIREMENTS:  

  • Master’s degree in Regulatory Affairs with minimum of 1 year experience or Bachelor’s degree in a scientific discipline with 3 years of job related experience.

ADDITIONAL EXPERIENCE REQUIREMENTS: 

  • Experience in a regulated industry (Pharmaceuticals, or Cosmetics, Medical Devices, Veterinary or Dietary Supplements). 
  • Cosmetic industry experience is highly desired. 
  • Good understanding of 21CFR part 820, part 700, ISO 13485, ISO 22716 and ISO 14971. 
  • Proficiency in Microsoft Office Suites.
  • RAPS-RAC is desirable, but not required.

OTHER QUALIFICATIONS: 

  • Detail oriented with well-developed organizational and analytical skills. 
  • Ability to work in a team environment and positive attitude is a plus. 
  • Experience working in a fast-paced, start-up environment is a plus.

Manufacturing Quality Engineer

FULL-TIME
PETALUMA, CALIFORNIA

DESCRIPTION

This position reports to the Director of Quality and supports the manufacturing quality activities by complying with GMP requirements. The incumbent is responsible for verification, validation, qualification, implementation of manufacturing process equipment, and the following duties:

  • Provides leadership in developing processes, methods, and criteria for inspections (incoming, in- process, and final product).
  • Reviews controlled documents including batch records, QC data, results, and master batch record for accuracy.
  • Identifies and resolves production and manufacturing problems or issues using quality tools and techniques such as root cause analysis, statistical analysis, and CAPA.
  • Performs calibration (Gauges, Timers, Meters, Calipers) of tools and equipment; conducts tests on installed automation-based process equipment (robotic systems).
  • Initiates, and reviews change orders, deviations, and manages control of non-conforming products.
  • Develops engineering specifications, sampling plans, test protocols, manufacturing floor process flows, work instructions, test methods, master validation plans, and performs any other quality related activities as assigned.
  • Determines conformance of products by following internal procedures and Quality System Regulation.
  • Regularly monitors product quality by gathering and maintaining manufacturing quality metrics.

EDUCATION REQUIREMENTS:  

  • Master’s degree in Mechanical Engineering with minimum of 2 years of experience in manufacturing environment or Bachelor’s degree in Mechanical Engineering with 4 years of experience in manufacturing environment.

ADDITIONAL EXPERIENCE REQUIREMENTS: 

  • Experience in manufacturing/production and process control in a regulated industry (Pharmaceuticals, Medical Devices, or Cosmetics or Dietary Supplements).
  • Good understanding of 21CFR part 820, part 700, part 11, GAMP, ISO 9001, ISO 13485 and ISO 14971.
  • Familiarity with automations systems, and PLC; Gage R&R, FMEA.
  • Sound knowledge of Quality Control, Statistical Process Control, & Capability Analysis and tools.
  • Proficiency in Minitab, Microsoft Office Suites and CAD Software/Solid Works.
  • ASQ-CQE is desirable but not required.

OTHER QUALIFICATIONS: 

  • Detail oriented with well-developed organizational and analytical skills. 
  • Ability to work in a team environment and positive attitude is a plus. 
  • Experience working in a fast-paced, start-up environment is a plus.

12-week Internship

12-WEEK INTERNSHIP
Petaluma, CALIFORNIA

DESCRIPTION

Collidion, Inc.’s internship program has two positions available for students seeking to develop laboratory-based research experience in the areas of pharmaceutical and medical device. We are looking for passionate chemists who are capable and excited about formulating products that meet the challenges facing global healthcare. Our regulatory, research & development, operations and creative teams work together to identify and build technologies that can improve the future of patients worldwide.

These positions will focus on laboratory-based research and product formulation opportunities in our Petaluma, CA facility. 

Research and Development

The R&D program provides an opportunity for students to work closely with senior scientists to improve technical skills and experience corporate laboratory structure while developing goal-oriented research programs. Students will be introduced to general aspects of product development and formulation. Each internship position focuses on translational (patent-oriented) basic laboratory research applicable for developing pharmaceutical products in the industrial setting. Students will learn about project planning based on U.S. Food and Drug Administration (FDA) requirements, project executing based on Standard Operating Procedure (SOP). Interns will be encouraged to take initiative, where appropriate. Interns will have the opportunity to participate in and present work during roundtable discussions with company management and executives. Experience will encompass: all phases of research, including, planning, writing protocols, preparation, calibration, organization, testing, data generation and documentation, data analysis / interpretation, and data presentation. 

Education Requirements

Currently pursuing an advanced degree in Chemistry or Organic Chemistry or a related field preferred. Students will be graduating between winter 2017 and spring 2020 school terms. A minimum completion of upper-division coursework in chemistry, organic chemistry, or equivalent area is required. Interns should have practical experience in the safe-handling of chemicals, operating laboratory equipment, generating and manipulating data, as well as relevant computer skills. 

  • Internship applications are due on November 30, 2016.
  • Internship positions are for 12 weeks, ability to start immediately.
  • Casual dress code.
  • Will be compensated at an hourly rate.
  • Extension will be considered on a case-by-case basis and at the sole discretion of the company.
  • Students must meet all laboratory, production safety, and compliance training programs at Collidion Inc. 

OTHER QUALIFICATIONS: 

  • Passionate work ethic. 
  • Strong interpersonal skills. 
  • Organizational and time management skills. 
  • Proficiency in Microsoft Suite.
  • Must be legally eligible to work in the U.S.