Overview
On Site
$DOE
Accepts corp to corp applications
Skills
regulatory
CMC
Job Details
Job Title: Regulatory Studio CMS Senior Manager
Work location: New Brunswick (preferred), Lawrenceville
Monday thru Friday - Normal business hours, with some flexibility
50% onsite - Team is onsite Monday thru Thursday
Top 3 to 5 skills/Must Haves:
Small Molecule Drug development experience (2 to 3 years)
Good communications skills (written/verbal)
Experience with Veeva System
PREREQUISITES BS/BA degree in Scientific Discipline (master's 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
The highlights are as below:
- Experience with Veeva System, documentam is must for the candidates
- Small Molecule (marketed products) Drug development experience (2 to 3 years)
- Expert in post approval submissions globally (mainly amendments for FDA, variations EU)
- Able to answer HA questions directly, direct coordination with HAs
- Exp in initial submission for MAA, NDA/IND/ANDAs will be brownie points
Work location: New Brunswick (preferred), Lawrenceville
Monday thru Friday - Normal business hours, with some flexibility
50% onsite - Team is onsite Monday thru Thursday
Top 3 to 5 skills/Must Haves:
Small Molecule Drug development experience (2 to 3 years)
Good communications skills (written/verbal)
Experience with Veeva System
PREREQUISITES BS/BA degree in Scientific Discipline (master's 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
The highlights are as below:
- Experience with Veeva System, documentam is must for the candidates
- Small Molecule (marketed products) Drug development experience (2 to 3 years)
- Expert in post approval submissions globally (mainly amendments for FDA, variations EU)
- Able to answer HA questions directly, direct coordination with HAs
- Exp in initial submission for MAA, NDA/IND/ANDAs will be brownie points
Accliive, is an IT Consulting Company working with Fortune 500 clients and is based out of Boston, MA. Accliive works extensively in all the major industries like BFSI, Oil and Gas, Utilities, Healthcare and many more. Acclive is focused on providing customer centric solutions and career centric solutions.
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