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Associate Principal Scientist, Regulatory Affairs DEPARTMENT: Global Regulatory Affairs - CMC LOCATION: Rahway, NJ USA Pay Rate: $70/HR on W2 Must Hv: Seeking R&D background experience along with the ...
Rahway, NJ · On-site
$70/hr
Associate Principal Scientist, Regulatory Affairs DEPARTMENT: Global Regulatory Affairs - CMC LOCATION: Rahway, NJ USA Pay Rate: $70/HR on W2 Must Hv: Seeking R&D background experience along with the ...
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South San Francisco, CA · On-site
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Somerville, NJ · On-site
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$35 - $38/hr
Perform analysis of materials and determine optimum safety stock." "Bachelor's Degree (preferred) or Associates Degree in Sciences, Engineering, Supply Chain Management, Business, or applicable.
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Product Surveillance Associate Pay Rate: 24-26/HR on W2 Location: Sturtevant, WI 53177 The Product ... scientific terminology. • Highly organized with attention to detail. • Strong ability to ...
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Boston, MA · On-site
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Boston, MA · On-site
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Scientist II - Assay development and compound profiling Rate: $32/HR Education Requirement: • BS/BA degree in biochemistry, biophysics or a related discipline with a minimum of 3-5 years industry ...
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... Associate degree in the field of entomology, crop protection, agriculture, biology, toxicology or related disciplinary sciences - Must be knowledgeable in the fundamental aspects of experimental ...
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No PHD or Associate degree. Education Minimum Requirement: • B.S. degree in a science field required, preferably biology, microbiology, or biological sciences. (Microbiology preferred) • M.S ...
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Collegeville, PA · On-site
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Collegeville, PA · On-site
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Lansdale, PA · On-site
$29/hr
Educational background at a minimum - Associate's Degree in the sciences or related field with 4 years in the pharmaceutical or related industry / Bachelor's Degree in the sciences or related field ...
Lansdale, PA · On-site
$29/hr
Educational background at a minimum - Associate's Degree in the sciences or related field with 4 years in the pharmaceutical or related industry / Bachelor's Degree in the sciences or related field ...
Educational background at a minimum - Associate's Degree in the sciences or related field with 4 years in the pharmaceutical or related industry / Bachelor's Degree in the sciences or related field ...
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West Point, PA · Remote
The Associate Principal Scientist will work closely with individuals from PaCES, Clinical Research, Regulatory Affairs, Biostatistics, Outcomes Research, and Operations to ensure COA endpoint ...
West Point, PA · Remote
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$18 - $23.75/hr
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$18 - $23.75/hr
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Florham Park, NJ · On-site
$20/hr
Preferred Associate's/Technical degree in Agronomy, Agricultural Sciences, or related fields. - Experience working in the field and greenhouse is desired.
Florham Park, NJ · On-site
$20/hr
Preferred Associate's/Technical degree in Agronomy, Agricultural Sciences, or related fields. - Experience working in the field and greenhouse is desired.
$24.50/hr
Minimum Associates of Science in Chemistry or a related technical field. Preferred Bachelors of Science in Chemistry or a related technical field. (for example, Chemistry, Chemical Technology ...
$24.50/hr
Minimum Associates of Science in Chemistry or a related technical field. Preferred Bachelors of Science in Chemistry or a related technical field. (for example, Chemistry, Chemical Technology ...
$70/hr
Full-time
Re-posted 4 days ago
JOB TITLE / VERSION: Associate Principal Scientist, Regulatory Affairs
DEPARTMENT: Global Regulatory Affairs - CMC
LOCATION: Rahway, NJ USA
Pay Rate: $70/HR on W2
Must Hv: Seeking R&D background experience along with the Regulatory Affairs background
Education:
Ph.D. with > 4 years, M.S. with > 7 years, or B.S with >10 years relevant industry experience in related R&D sciences discipline (engineering, chemistry, biological sciences, pharmacy, veterinary, regulatory)
Skills Required:
• Required: minimum of 2 years authoring CMC sections for regulatory submissions.
• Preferred: experience and skills in a supervisory role and metrics development.
Competencies Required:
• Hands on experience in R&D pharmaceutical development (formulations- development pharmaceutics, process technology, analytical method development and validation, and/or packaging development)
• Experience authoring technical reports and regulatory submissions, experience reviewing scientific information, with sound judgement and attention to detail
• Demonstrated understanding of cross-functional relationships across the business (manufacturing, packaging, quality control and assurance as well market demands and supply chain)
• Strong Leadership skills (problem-solver), communication and interpersonal skills with high level of professionalism to collaborate with internal partners and to liaise with regulatory authorities (CVM/FDA, EMA)
• Proficient in English, both written and oral
• Ability to manage multiple projects and products, with high level of organizational skills for prioritization planning, and with flexibility and technical acumen to shift roles on short notice.
Software:
• Experience with Veeva Vault is nice to have
• Experience with ETQ is nice to have
Notes:
• 1 Year assignment with a possibility of extension.
• Hybrid - 3days onsite(Tues and Wed is must)
Responsibilities:
The Associate Principal Scientist is responsible for developing CMC regulatory submission strategies and timelines for assigned pharmaceutical projects/products in accordance with global regulations and guidance. The Associate Principal Scientist is also responsible for the preparation and review of information required for development of regulatory CMC dossiers for new and existing commercial products.
MAJOR ACTIVITIES AND RESPONSIBILITIES
60% to 80%:
• Work independently and effectively to manage and author regulatory CMC dossiers, renewals/annual reports, variations/supplements, and responses to authority questions as required in each country in order to gain new and maintain existing product registrations.
• Review technical reports and scientific information provided to support regulatory submissions
• Identify potential risks and propose mitigation strategies; communicate potential regulatory issues to management, as needed.
• Critically evaluate health authority questions with the respective CORA and lead the answer team of cross-functional SMEs to compile the responses in order to author and submit the responses timely to meet health authority deadlines
• Actively participate on new product development teams as well as other project teams and initiatives and deliver on all assigned regulatory milestones.
10% to 20%:
• Change Management Regulatory Impact Assessment: Provide regulatory assessments for post approval change proposals, filing strategies and timelines
• Renewals and Geo-Expansions: Support license renewals and geo-expansion activities by supporting CORA requests for dossiers and GMP documentation
• Maintain regulatory information in accordance with processes and procedures to support regulatory compliance
• Continuously build and share knowledge of CMC-related global regulations and guidelines, authority expectations, as well as current industry standard, while also helping to coach others in a collaborative manner, using good communication
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11 - 50 Employees
Sugar Land, TX, US