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Manager, Regulatory Affairs CMC in Waltham, MA at Integrated Resources, Inc

Date Posted: 10/24/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Waltham, MA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    10/24/2018

Job Description

Job Title: Manager, Regulatory Affairs CMC
Location: Waltham, MA
Duration: 12 Months (Contract To Hire)

Job Description:
This position is responsible for preparation of CMC submissions for Biologics products. This position will also assist the Regulatory CMC team with special projects as assigned.
Looking for someone who is senior. Role will be considered a Manager position

II. Duties and Responsibilities:

Responsible for implementing regulatory strategies, including filing of all appropriate regulatory submissions for assigned programs.
Responsible for coordinating all aspects of regulatory CMC submissions relevant to assigned projects or programs
Identify and assess regulatory risks associated with product development for assigned programs. Assist in defining strategies to mitigate risks
Guide the organization and preparation of clear and effective submissions.
Ensures completion of high-quality submissions, adhering to regulatory guidelines, regional specifications, and company standards
Monitor and analyse appropriate regulatory agency activities in areas of interest to the company. Assess impact on specific projects
Assess compliance of CMC document with the current Guidelines and Regulations
Assess regulatory impact of proposed CMC changes to licenses or clinical trial applications

III. Qualifications:

BA/BS/University degree required, Life/Health Sciences preferred.
A minimum of 7 years in the Pharmaceutical Industry, and a minimum 5 years regulatory CMC experience (Biologics)
Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload.
Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals.
Demonstrate excellent communication skills.
Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload.
Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.
Demonstrate effective cross-cultural awareness and capabilities.
Some direct experience in interfacing with relevant regulatory authorities.
Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
Good knowledge and understanding of applicable regulations.
Experience in interpretation of regulations, guidelines, policy statements, etc.
Computer literate.
Sensitivity for a multicultural/multinational environment.
Some International regulatory experience preferred.
Knowledge of biotech manufacturing and analytical technology.
Good knowledge of CMC change control guidance.
Good knowledge of local and international GMP requirements.
Direct and broad experience in cross-functional CMC biopharmaceutical product development is required
Experience with early-stage CMC development and clinical manufacturing of biologics is strongly preferred
Experience leading global and/or virtual teams is preferred
Direct experience with CMC technical content for regulatory submissions is preferred Skills/Knowledge/Competencies