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Adecco Healthcare & Life Sciences is seeking a skilled **CMC Regulatory Technical Writer II** to support a global pharmaceutical client in lifecycle management (LCM) programs. This role contributes to regulatory dossiers across US, EU, and other regions (e.g., NDA, MAA, IND, IMPD) by authoring and reviewing Chemistry, Manufacturing, and Controls (CMC) documentation. The ideal candidate works independently, collaborates across multiple teams, and ensures regulatory compliance while maintaining high-quality documentation standards.

**Pay:** $50- 56/hr based on education and relevant experience level

Key Responsibilities:

+ Author and develop CMC sections of regulatory dossiers (Modules 2 and 3) for development and post-approval submissions.

+ Draft responses to health authority inquiries, dossier amendments, supplements, variations, and annual reports.

+ Prepare and evaluate change controls for global regulatory impact; occasionally author technical reports, position papers, white papers, or SOPs.

+ Ensure all content aligns with regulatory guidelines, source documentation, and organizational templates.

+ Collaborate with cross-functional teams including Quality, Manufacturing, Global Regulatory Affairs, and Contract Manufacturing Organizations (CMOs).

+ Support regulatory risk mitigation strategies and maintain up-to-date knowledge of industry guidelines, SOPs, and regulatory requirements.

+ Manage timelines, priorities, and deliverables for regulatory submissions efficiently and independently.

Skills and Experience:

+ Minimum of 5 years’ experience in the pharmaceutical industry, with expertise in CMC documentation and CTD authoring.

+ Strong understanding of US pharmaceutical regulations; exposure to ex-US regulations is desirable.

+ Background in pharmaceutical manufacturing, quality control, or quality assurance is a plus.

+ Experience with document management systems (e.g., Veeva, Documentum) preferred.

+ Knowledge of cGMP requirements and small-molecule products; experience with aseptic or medical device products is a plus.

+ Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

+ Exceptional organizational skills, attention to detail, and ability to work independently with minimal supervision.

+ Strong interpersonal communication skills and proven ability to collaborate within multi-disciplinary teams.

Education:

+ BS/BA, MS, or PhD in a science or health-related field (e.g., Biology, Analytical Chemistry, Pharmacy, or related discipline).

Location:

+ Fully remote.

+ If local to Morristown, NJ, hybrid work is expected.

Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria.

**Pay Details:** $50.00 to $55.90 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://uat.adecco.com/en-us/candidate-privacy

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

+ The California Fair Chance Act

+ Los Angeles City Fair Chance Ordinance

+ Los Angeles County Fair Chance Ordinance for Employers

+ San Francisco Fair Chance Ordinance

**Massachusetts Candidates Only:** It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.