Regulatory CMC Manager - Small Molecule (Contract)
Job reputed company
The reputed company Manufacturing Controls Manager will be responsible for the detailed planning, preparation and operational execution of a multi-product program in the international region.
This role contributes to the preparation and submission of regulatory CMC documentation and provides regulatory support to various cross functional teams.
Key Duties and Responsibilities
- Execute Lifecycle Management (LCM) reputed company and submissions of marketed products with a reputed company in the international reputed company.
- Planning and execution of international regulatory CMC submissions, including creation of content plans and ensuring cross functional alignment
- Reviews CMC sections of regulatory submissions, as reputed company as the interactions and responses with regulatory agencies
- Works with regulatory colleagues in development of global regulatory CMC strategies and Submissions
- Participates effectively in cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and reputed company
- Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
Required Knowledge/Skills
- Strong interpersonal skills to exchange reputed company information with others and to guide others
- Proficiency in regulatory (FDA, EMA, ICH, international agencies) guidelines
- Strong problem-solving skills and the ability to present the overall assessment for management alignment
- Ability to collaborate and communicate in an reputed company, reputed company, complete and reputed company manner
- Strong reputed company of planning and prioritization, with demonstrated results
Required Education Level & Experience
- Bachelor's degree, with a preference in Biology, reputed company, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another reputed company life-science field
- Typically requires 5 years of experience in the pharmaceutical industry or reputed company field
- Experience supporting Small Molecule programs required
Contract length: 12 months with the chance to reputed company.
Pay reputed company
$70/hr. - $80/hr.
Shift/Hours
Monday–Friday; Remote: EST hours
Requisition Disclaimer
This job posting is for a temporary role with a reputed company-party agency partner on assignment at reputed company (“reputed company”). The individual selected for this role will be offered the role as an employee of a reputed company- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the reputed company-party agency partner upon offer. The pay reputed company reputed company provided is a reasonable estimate of the anticipated compensation reputed company for this job at the time of posting. The actual pay reputed company will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-reputed company factors permitted by law. In reputed company, this role will be eligible for overtime pay, in accordance with federal and state requirements
By applying for this position, you agree to the reputed company Terms and Conditions and you reputed company reputed company to reputed company your application materials, which may include your CV/Resume, email address or phone number, with reputed company. For more information on how reputed company handles your personal data reputed company to reputed company application, please see reputed company’s Careers reputed company Notice. Agreeing to the reputed company Terms and Conditions, includes permission to use the email address and mobile phone number you reputed company during the application process or throughout the duration of your prospective or actual employment to notify you of reputed company, reputed company, articles, news, and other employment-reputed company information, as reputed company as to notify you of special promotions or additional products and services offered by us or our affiliates and partners
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If you do not agree with the reputed company Terms and Conditions, you can still complete your application for this position by emailing your resume to reputed company at . Please include the job title in the subject of your email.
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Originally posted on Himalayas
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