Thursday, 13 June 2024

Immediately Needed==CMC Senior Manager, 100% Remote

Posted On

Hi,

Pleasure mailing you. Please go through the below requirement and let me know if you are comfortable for the position.

Please send me your updated resume along with the best hourly rate, work authorization status and availability.

An early response is really appreciated.

Job Title: CMC Senior Manager

Location: 100% Remote

Duration: Contract

Job Description:

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:

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.
Prepare and review CMC submission documents, registration dossiers, and responses to health authorities through collaborations with relevant line functions and with minimal supervision.
May be responsible for the global regulatory evaluation of CMC change controls with supervision.
Work with CMC cross-functional teams and Regulatory Affairs teams.
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