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Job Title: CMC Senior Manager
Primary Skills : CMC regulatory, project management, Sterile Injectable experience
Location: Short Hills, NJ,
Duration : 12 Months
Job Description:
Job Description: Regulatory & Medical Affairs - Regulatory Studio - CMC Senior Manager
PREREQUISITES BS/BA degree in Scientific Discipline (Masters or higher preferred) with
5 years in the pharmaceutical industry, preferably with 3 years CMC regulatory experience, Sterile Injectable experience preferred.
Responsibilities will include, but are not limited to, the following:
1. Participate in the development of the CMC regulatory strategy for post-approval small molecule product submissions, including global supplements/variations and responses to health authority queries.
2. Prepare and review CMC submission documents, registration dossiers, and responses to health authorities through collaborations with relevant line functions and with minimal supervision.
3. May be responsible for the global regulatory evaluation of CMC change controls with supervision.
4. Work with CMC cross-functional teams and Regulatory Affairs teams.
5. Develop and maintain knowledge of regulatory environment, regulations and procedures.
Skills/Knowledge Required:
- Experience with CMC regulatory documents (global registrations, including NDAs, MAAs and others, responses and supplements/variations)
- Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations
- Experience in post-approval requirements
- Experience in developing CMC regulatory strategy
- Experience in project management
- Have a solution-oriented approach to problem solving
- Ability to plan/prioritize work of group members and guide/develop others.
- Ability to work on complex projects and within cross-functional teams with supervision
- Excellent communication skills, both written and oral
- Excellent computer skills
Thanks & Regards
Shaik Sadeq
Infobahn Soft world Inc.
Email: Sadeq@infobahnsw.com
Contractor
IT Outsourcing & Consulting
$94k-126k (estimate)
06/10/2024
07/07/2024
infobahnsw.com
SAN JOSE, CA
25 - 50
1996
Private
MANEESHA CHANDRA
$5M - $10M
IT Outsourcing & Consulting
The following is the career advancement route for Regulatory Manager positions, which can be used as a reference in future career path planning. As a Regulatory Manager, it can be promoted into senior positions as a Regulatory Affairs Senior Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Manager. You can explore the career advancement for a Regulatory Manager below and select your interested title to get hiring information.