CTG CMC Regulatory Associate in Morristown, New Jersey
Title: CMC Regulatory Associate
Job Number: 19206273
CTG Inc. has been a highly respected provider of contract personnel throughout the United States for more than fifty years.
Currently, our valued client in Morristown, NJ has an opening for an CMC Regulatory Associate. This position is a 12-month contract, with the potential for continuation after the initial contract.
The maximum W2 hourly pay rate is $37.50/hr., based on experience and ability.
The CMC Documentation Team is responsible for the development of Chemistry, Manufacturing and Control (Module 3) documentation for the commercial products within the portfolio.
Under the broad guidance of the CMC product leads, the job entails supporting the CMC Documentation team in the preparation of CMC registration documents. The person will be responsible for the creation and maintenance of regulatory CMC documents in the controlled document management repository.
The job purpose is to prepare technical CMC registration documents in order to
maintain the existing marketing authorization (i.e. dossier updates, variations, renewals, response to deficiency letters, compliance gap closures) in various countries where business is being conducted.
POSITION DUTIES & RESPONSIBILITIES
Create/edit technical documents to ensure the on-time compilation of high quality CTD Module 3 and QOS documents that are ready for submission
Discuss and align with project team on strategy for maintenance activities for
products under his or her responsibility
Evaluate change requests with a goal of defining technical requirements according to guidelines, evaluate and provide input on technical data to support product changes
Create or update the technical registration dossiers (CTD Module 3 and QOS or equivalent) of pharmaceutical/OTC products
Maintain knowledge of current industry requirements and standards for CTD Module 3 and QOS or equivalent
Work cross functionally to coordinate the preparation of draft responses to technical regulatory questions from health authorities
Bachelor’s degree with 1 or more years of proven experience, or
Associate’s degree with 3 or more years of proven experience
Skill & Competency Requirements:
Experience in global CMC regulatory
Experience in creating CTD sections (Module 3)
Excellent writing skills
Demonstrated ability/experience managing IT based scientific systems
Experienced in the US regulatory environment
Experience in post-approval CMC changes
Fluent in English (German and/or French speaking is a plus)
If interested, apply below or send your resume to Gary Mcafee at email@example.com. Please reference job #19206273 in the subject line.
CTG’s Benefits Plan allows you to select insurance coverage that best suits your lifestyle, and take part in our savings programs and educational plans. We offer Flexible Spending Accounts, a 401(k) Retirement Plan, and an Employee Stock Purchase plan. Our educational plan comprises access to more than 2,000 web-based technical, professional and business development courses.
CTG (NASDAQ: CTG) provides industry-specific IT services and solutions that address the business needs and challenges of clients in high-growth industries in North America and Western Europe. CTG also provides strategic staffing services for major technology companies and large corporations. Backed by more than 50 years of experience and proprietary methodologies, CTG has a proven track record of reliably delivering high-value, industry-specific staffing services and solutions to its clients. CTG has operations in North America, Western Europe, and India.
CTG's greatest asset is its people, and as such, we are committed to providing employees programs and processes to support their performance, hone their skills, and advance in their careers. This commitment is reflected by CTG being named a Best Places to Work in Healthcare company by Modern Healthcare (2013-2016) in North America, and a Best Workplace in the United Kingdom (2013), Belgium (since 2007), and Luxembourg (since 2011).
CTG will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of all applicable local, state, and federal laws.
CTG is an Equal Opportunity/Affirmative Action Employer and strong advocate of workforce diversity. Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran.
Job: Documentation Management