Company Info

Job Description

As the Senior Manager CMC, Regulatory Affairs (Specialty Products - Biologics) you will be responsible for developing, coordinating, and supporting the CMC aspects of regulatory submissions to global Health Authorities for new specialty products and marketed product registrations as well as licensing opportunities.  You may also be required to serve as the global regulatory project leader (GRPL).

You will lead and implement regional and/or global CMC strategy & submission activities, including planning, writing, review, coordination and submission of CMC sections of Briefing Packages, meeting requests, INDs, NDAs/ BLAs, CTAs, MAAs and other regulatory filings for assigned development projects and marketed products. In addition, you will arrange for, coordinate and lead the team in planning, preparation, and execution (lead facilitator) of meetings or teleconferences with Health Authorities (e.g., FDA, EMA).

Able to travel domestically (10%) and internationally (5%) when needed.

Other duties and responsibilities: 

• Anticipates and understands the needs of internal and external customers.
• Able to identify current key issues and anticipate key future issues and take them in consideration in the planning and management of projects.  Able to challenge the status quo to achieve continuous improvement.
• Able to influence through communication based on logic and reason and to respond constructively to the needs of others. Able to negotiate effectively.  
• Demonstrates the ability to evaluate critical data in order to identify the cause of a problem, seek appropriate expertise, and resolve or facilitate resolution.  Thinks through consequences of different courses of action.  
• Working knowledge of relevant drug and biologic laws regulations and guidances / guidelines
• Knowledge of pharmaceutical drug development process
• Proficient in project management. Demonstrates and encourages collective responsibility in teams. 

Qualifications

What you will bring to the role:

• Bachelors degree in scientific field of study such as Biochemistry, Biotechnology, Cell Biology or equivalent
• Minimum 7 years of pharmaceutical industry experience in new drug related product strategy and submissions 

Preferred Qualifications:

• Masters degree or PhD, PharmD
• Minimum 8 years of experience in regulatory affairs with proven experience in successful filing and defense of major submissionIND/NDA/BLA/CTA/MAA
• Strong background in pharmaceutical development with focus on CMC aspects
• Experience in implementing principles embodied in ICH Guidances Q8, 9, 10 including ObD

Function

Sub Function

Reports To

Director, Regulatory Affairs CMC

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