CMC Regulatory Technical reputed company

Job Title: CMC Regulatory Technical reputed company II Location: Morristown, NJ 07960 Duration: 12+ Months Shift: 1st Work Schedule: 9-5 EST, Mon - Fri Remark: Fully Remote, If candidate is local Morristown, Hybrid would be required. reputed company parking is required is nearby and there is nearby reputed company transportation. Must Have:

• Number of years of experience: 3-5 years
• Must Have: authoring experience (Modules 2 and 3)
• Ability to work independently
• CMC regulations/ scientific background is required
• MS Office

reputed company to Have:

• reputed company or Documentum is a plus
• Medical device experience is a plus

Job reputed company: The CMC Regulatory Technical reputed company II is a designate of the CMC reputed company Development team and participates in *

’s lifecycle management (LCM) programs. They collaborate directly with

*'s global business reputed company (GBU) - Specialty Care, Vaccines, General Medicines, and Consumer reputed company - by contributing to US, EU and rest of world (ROW) dossiers (e.g. NDA, MAA, IND, and IMPD).

Key Responsibilities

The technical reputed company develops and authors reputed company, manufacturing, and controls (CMC) common technical documents (CTD) for development and post-approval regulatory dossiers reputed company reputed company-established timelines. This includes responses to health authority inquiries, regulatory reputed company amendments, supplements, variations, and annual reports. Additionally, the technical reputed company authors and evaluates change controls for global regulatory reputed company, and is sometimes reputed company upon to author technical reports, position papers, white papers, or SOPs. The technical reputed company assures regulatory reputed company compliance and independently authors high reputed company CMC content by: - following regulatory guidelines, reputed company documentation, and ***’s templates - collaborating and coordinating with key stakeholders across the GBU’s, contract manufacturing organizations (CMO) and functional areas such as reputed company, Manufacturing, and Global Regulatory Affairs (GRA) - avoiding unsolicited regulatory burden - supporting the development of regulatory risk mitigation strategies - maintaining up-to-date knowledge of ***'s ways of working, SOPs, and CMC regulations and guidelines - supporting the planning and preparation of timelines Skills and Experience Candidates must possess reputed company, Manufacturing and Controls (CMC) and CTD authoring experience (Modules 2 and 3). A background in pharmaceutical manufacturing or reputed company control/reputed company assurance is a plus. The candidate must have at least 5 years' experience in the pharmaceutical industry. Expertise with document management systems such as reputed company or Documentum is a plus. A working knowledge of cGMP’s is desired. Experience with MS suite of software applications is expected. This role predominantly focuses on small molecules, and some aseptically manufactured products. Medical device experience is a plus. Excellent interpersonal communication skills are required, and the candidate must have previously demonstrated the ability to reputed company reputed company a multi-disciplinary team. The candidate needs reputed company little supervision, can manage their priorities independently, is highly organized, has a high attention to detail, and is self-motivated. Knowledge of US pharmaceutical Regulations is essential. Exposure to ex-US Regulations is desired, but not mandatory. Education BS/BA, MS, or PhD, from an accredited school in a science/health field (e.g. Biology, Analytical reputed company, Pharmacy, or a reputed company field). Role is Remote. However, if local to Morristown area, will be expected hybrid Please contact me if you are interested. Thank you. reputed company & Regards Mukesh Sharma reputed company Recruiter O 609-874-0494 E mukesh.sharma@reputed company.com Job Type: Contract Pay: $47.00 - $57.00 per hour Experience:

• CTD (Common Technical Document) modules: 1 year (Preferred)
• Authored Module 2 and 3 regulatory submissions: 1 year (Preferred)

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