(US-Michigan-Grand Rapids) This position will be responsible for the analysis and interpretation of regulations as well as development and approval of test methodologies in domestic and international markets to ensure the company's numerous and varied products are safe for customer use. Working in a fast paced, collaborative, team based environment, act as an active, influential, contributing, and recognized authority in the field of product safety and risk assessment to help the business make savvy, rational and sound decisions regarding new and existing products. Primary focus will be skin, personal care and oral nutritional products. Research and clearly communicate findings and make recommendations to a variety of technical and non-technical audiences. Also, lead, develop and monitor test methodologies and results of contract test suppliers in U.S. and Japan. Position offers opportunity for research in skin care. Some travel is required. QUALIFICATIONS A Master’s or Doctorate in Toxicology or related discipline along with several years of related commercial toxicology experience is required. Possess strong skills and experience in domestic and international product safety and risk assessment. Experience in assessment of products used in skin care and nutritionals is preferred. Demonstrated skills in written and oral communications, teamwork, leadership, analysis, planning and organization, ingenuity and creativity, judgment and display an understanding of business.
(Canada-British Columbia-Vancouver) Recruiting a Senior Director, Regulatory Affairs for a company in Vancouver, British Columbia. They are dedicated to developing cancer treatments that are more effective and have fewer side effects for many types of cancer. They provide a supportive work environment for their employees - recognizing and rewarding outstanding performance. They treat each other with mutual respect and consideration. This position offers excellent opportunities for career growth and outstanding financial rewards. Job Description: Drawing on your extensive, hands-on experience, you will strategize, develop and direct Technical Regulatory Affairs programs and activities to ensure that submissions, reports and filings meet North American and European regulatory requirements. You are an enthusiastic communicator, team player and coach, able to guide and direct multidisciplinary technical departments to deliver programs and documents that are acceptable for regulatory approval. Requirements: A degree in chemistry, chemical engineering, or a biological or pharmaceutical discipline is required. A PhD is a plus. Experience in managing agency relationships, ideally the FDA, is required. Must have a minimum of 5 years of regulatory experience in the pharmaceutical industry that has focused on Chemistry, Manufacturing and Controls and has spanned Pre-Clinical research to post approval activities. Experience in preparation and submission of regulatory documents such as IND's and NDA's is required. Expertise in European regulatory requirements and parenteral products are assets.
(US-Massachusetts) Supervisory experience, small molecules, method development, Mass Spec. If you possess these attributes, you should read on! Responsibilities: An opportunity currently exists to manage and lead a team of scientists (10-15) focused on analytical method development and HT characterization of synthesis products. You and your group will work closely with peers from synthetic chemistry and parallel synthesis operations to assure an efficient process and productive work flow. Education: PhD with Post-Doc. Requirements: You should have 10+ years of biotech/pharma industry experience. A strong background in separation science or mass spectroscopy combined with quality control/characterization of small organic molecules.
(US-Massachusetts) Direct the daily operations and management of a growing biotechnology facility, including buildings, campus, safety and services. Actively ensure Company compliance with all permits, licensure, GCP, GLP, GMP and safety regulations. Create, drive, support and foster an environment that matches Company philosophy. Drive the development of current as well as future facilities, buildings, services and environment. Direct the management of internal services and vendors. Strategically drive and source Facility Maintenance functions as needed through a combination of staff, contractors, leased employees and temps. Education: Bachelor’s degree required, additional certifications a plus. Requirements: Minimum of 10 – 15 years of facilities experience, including at least 5 years in GLP, GCP and GMP environment and at least 5 years management experience. Biopharmaceutical or biotech background required. Strong working knowledge of OSHA standards and building codes required. Certification and/or significant and relevant experience in HVAC, steam, water systems, electrical and piping preferred. Through understanding of GMP, GLP, and GCP is essential. Proven ability to read, understand technical manuals, schematics, and plans required. Experience in an FDA regulated industry is preferred. Ability to create and build the Facilities Management team. Ability to interact and related with all levels of management as well as employee population. Prepare and deliver PowerPoint presentations on Facilities.
(US-Massachusetts) Reporting to the CMO you will be charged with managing and driving all aspects of an oncology clinical development program. Responsible for all aspects of Phase 1-4 development including but not limited to site selection, protocol development, trial initiation, clinical regulatory submissions, monitoring oversight, and data analysis. Manage all aspects of external vendor contracts including CROs. In this position, you will assist in developing clinical trial protocols; manage, train, and mentor clinical trial managers; research, write, and edit clinical reports; work with internal and external stakeholders to design clinically sound development strategies; ensure completeness, accuracy and validity of clinical data; assure compliance with internal SOPs, FDA regulations and GCP; and participate in clinical regulatory submissions. Participation in regulatory submission including INDs, IND safety reports, BLAs, product labeling package inserts, and other reports as necessary. Manage all aspects of clinical program budget. Sound exciting?? Read on to see if you qualify! Qualifications: Masters degree (Ph.D. preferred) and 5+ years of clinical research and clinical program management experience in an industry setting. Oncology and biologics experience strongly preferred. Experience in developing clinical development plans (pivotal trial experience highly preferred), clinical trial design, protocol development, managing the writing of clinical sections of regulatory submissions, and management of industry-sponsored clinical trials required. Comprehensive knowledge of drug clinical development processes (Phase I – III), policies, and regulations. Extensive CRO management experience required. Participation in preparation and management of major regulatory submissions.
