$103K - $138K/yr
... and CMC Assist in developing and implementing strategies for the earliest possible approvals ... Work with external regulatory consultants/CRO's as required Qualifications: BA / BS in Health ...
$103K - $138K/yr
... and CMC Assist in developing and implementing strategies for the earliest possible approvals ... Work with external regulatory consultants/CRO's as required Qualifications: BA / BS in Health ...
$121K - $161K/yr
... CMC * Assist in developing and implementing strategies for the earliest possible approvals ... Work with external regulatory consultants/CRO's as required Qualifications: * 5+ years' related ...
$121K - $161K/yr
... CMC * Assist in developing and implementing strategies for the earliest possible approvals ... Work with external regulatory consultants/CRO's as required Qualifications: * 5+ years' related ...
$10.10 - $16.70
9% of jobs
$20.05 is the 25th percentile. Wages below this are outliers.
$16.70 - $23.30
31% of jobs
$23.30 - $29.90
9% of jobs
The median wage is $30.08 / hr.
$29.90 - $36.49
19% of jobs
$36.49 - $43.09
2% of jobs
$45.43 is the 75th percentile. Wages above this are outliers.
$43.09 - $49.69
13% of jobs
$49.69 - $56.29
3% of jobs
$56.29 - $62.89
0% of jobs
$62.89 - $69.49
0% of jobs
$69.49 - $76.09
5% of jobs
$76.09 - $82.69
8% of jobs
$10
$38
$82
| Aspect | Hourly Cmc Consultant | Contract Cmc Specialist |
|---|---|---|
| Credentials | Typically requires a degree in life sciences, with industry certifications | Similar credentials, often with additional specialized training |
| Work Environment | Consulting firms, biotech or pharma companies, project-based | Contract roles within biotech or pharma companies, project-specific |
| Employer & Industry Usage | Used by consulting firms and biotech companies for temporary expertise | Engaged directly by companies for specific projects |
Both roles involve working on CMC (Chemistry, Manufacturing, and Controls) projects in the biotech and pharmaceutical industries. The main difference lies in employment type: Hourly Cmc Consultants typically work on a flexible, hourly basis through consulting firms, while Contract Cmc Specialists are hired directly for specific projects on a contractual basis. Both require similar credentials and industry experience, but their work arrangements and employer relationships differ.
Cities with the most Hourly Cmc Consultant job openings:
The most popular types of Cmc Consultant jobs are:
States with the most job openings for Hourly Cmc Consultant jobs include:
The top searched job categories for Hourly Cmc Consultant jobs are:
$103K - $138K/yr
Full-time
Medical, Dental, Vision, Life, Retirement, PTO
Re-posted 4 days ago
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
General Description:
BeOne is seeking an experienced and energetic person to manage, evaluate, and complete regulatory projects consistent with company goals. This individual will be responsible for timely planning and coordination of regulatory submissions and provide guidance to cross-functional teams on regulatory strategy and tactics. The Sr Associate will assist the Regulatory Affairs team member on cross-functional project teams and will assist on authoring and preparation of annual reporting, and will manage regulatory submissions and regulatory archive.
Essential Functions of the job:
With minimal supervision, plan and manage regulatory activities related to assigned projects that span technical areas including clinical, non-clinical, and CMC
Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects
Manage the preparation, including writing as necessary, assembly, review, and timely submission of regulatory dossiers as required for investigation and registration of products in the US and abroad
Ensure regulatory submissions are maintained in compliance with regulatory requirements. Support and manage preparation of meeting requests and briefing documents
Manage the preparation, review, and submission of all components of regulatory submissions including INDs and amendments, BLAs/NDAs and supplements, annual reports, safety reports, etc. Participate on project teams and provide expertise on regulatory matters
Develop and maintain current regulatory knowledge and advise management of significant developments. Prepare and maintain regulatory archive. Work with external regulatory consultants/CRO's as required
Qualifications:
BA / BS in Health Science, preferred, with at least 4+ years' experience in the pharmaceutical industry
Experience and knowledge in preparation of INDs (required) and NDAs (desirable), and supportive amendments and supplements (manufacturing, nonclinical, clinical)
Experience with CTD/eCTD. Experience with publishing documents in Adobe Acrobat Professional. Working knowledge of FDA and ICH regulatory guidance and regulations
Understanding of FDA structure and function. Knowledge/experience with regulatory requirements for other regions also desirable
Working knowledge of GMP, GLP, and GCP regulations as well an understanding of the pharmaceutical product life cycle. Excellent oral and written communications skills are a must as are superior planning skills
The candidate should be detail-oriented, a self-starter, and be comfortable with broad responsibilities in an entrepreneurial, fast-paced, small company environment
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.