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Associate Director, Regulatory Affairs Job. Job in Berkeley Heights, New Jersey, United States in Celgene Corporation. Nelest.com
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Associate Director, Regulatory Affairs Job

col-narrow-left   

Job ID:

23217

Location:

Berkeley Heights, NJ 

Job function:

Rotational / Leadership Development Program
col-narrow-right   

Posted:

03.11.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Associate Director, Regulatory Affairs Job

Job Description:

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing we look for talented people to grow our business, advance our science and contribute to our unique culture.

Responsibilities will include, but are not limited to, the following:
1. Develop and direct implementation of global regulatory strategy for assigned projects, along with Regional Regulatory Affairs representatives and Regulatory CMC
2. Lead global and/or regional regulatory team on assigned projects
3. Develop and execute US regulatory strategy and contingencies for assigned projects
4. Serve as the primary interface for FDA on assigned projects
5. Lead the preparation of submissions, which may include INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications, etc. Work with functional groups to define contributions to submissions. Lead regulatory submission teams for projects assigned. Serve as the primary interface with Regulatory CROs for coordination and preparation of submissions
6. Prepare company team for FDA and other Health Authority meetings, as required
7. In collaboration with the Celgene Risk Evaluation and Mitigation Strategies (REMS) Department, provide Regulatory leadership and strategic input for REMS programs
8. Participate in and may lead FDA meetings focused on REMS policy and strategy
9. Represent Regulatory Affairs on various cross-functional teams, including Project Teams, Clinical Teams and Study Teams
10. Communicate project regulatory strategies and plans to management, cross-functional teams and any partners/collaborators to establish alignment
11. Be a strategic partner and team player in the various governance committees within the company
12. Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidance's
13. Contribute to the development and maintenance of Regulatory Affairs practices and procedures

*LI-SH1

Job Requirements:


Skills/Knowledge Required:

- Bachelor's degree in scientific discipline, Advanced scientific degree preferred
- Experience in multiple phases of development in various therapeutic areas. Experience in Oncology or Inflammatory and Immune diseases preferred.
- 7-10 years pharmaceutical industry experience, including 5-7 years in Regulatory Affairs. Global experience desirable.
- Knowledge of global regulations and guidances as they relate to the overall global regulatory strategy
- Thorough knowledge of the drug development process and global submission process
- Demonstrated experience in working with the FDA
- Inter-dependant partnering skills, team-oriented with demonstrated ability to influence outcomes are necessary skills in the environment
- Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.
- Must be able to innovate, analyze and solve problems with minimal supervision and attention to detail
- Domestic and occasional International travel may be necessary
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

C

Travel: Yes, 20 % of the Time

Zip Code:

07922

Company Info
Celgene Corporation
86 Morris Avenue
Summit, NJ, United States

Phone: +1-908-673-9000, +41 32 729 85 00, 1-908-673-9800, 1-908-673-9800
Web Site: www.celgene.com

Company Profile

Company Info


Celgene Corporation
86 Morris Avenue
Summit, NJ, United States
Phone: +1-908-673-9000, +41 32 729 85 00, 1-908-673-9800, 1-908-673-9800
Web Site: www.celgene.com

Associate Director, Regulatory Affairs Job

col-narrow-left   

Job ID:

23217

Location:

Berkeley Heights, NJ 

Job function:

Rotational / Leadership Development Program
col-narrow-right   

Posted:

03.11.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Associate Director, Regulatory Affairs Job

Job Description:

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries - and growing we look for talented people to grow our business, advance our science and contribute to our unique culture.

Responsibilities will include, but are not limited to, the following:
1. Develop and direct implementation of global regulatory strategy for assigned projects, along with Regional Regulatory Affairs representatives and Regulatory CMC
2. Lead global and/or regional regulatory team on assigned projects
3. Develop and execute US regulatory strategy and contingencies for assigned projects
4. Serve as the primary interface for FDA on assigned projects
5. Lead the preparation of submissions, which may include INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications, etc. Work with functional groups to define contributions to submissions. Lead regulatory submission teams for projects assigned. Serve as the primary interface with Regulatory CROs for coordination and preparation of submissions
6. Prepare company team for FDA and other Health Authority meetings, as required
7. In collaboration with the Celgene Risk Evaluation and Mitigation Strategies (REMS) Department, provide Regulatory leadership and strategic input for REMS programs
8. Participate in and may lead FDA meetings focused on REMS policy and strategy
9. Represent Regulatory Affairs on various cross-functional teams, including Project Teams, Clinical Teams and Study Teams
10. Communicate project regulatory strategies and plans to management, cross-functional teams and any partners/collaborators to establish alignment
11. Be a strategic partner and team player in the various governance committees within the company
12. Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidance's
13. Contribute to the development and maintenance of Regulatory Affairs practices and procedures

*LI-SH1

Job Requirements:


Skills/Knowledge Required:

- Bachelor's degree in scientific discipline, Advanced scientific degree preferred
- Experience in multiple phases of development in various therapeutic areas. Experience in Oncology or Inflammatory and Immune diseases preferred.
- 7-10 years pharmaceutical industry experience, including 5-7 years in Regulatory Affairs. Global experience desirable.
- Knowledge of global regulations and guidances as they relate to the overall global regulatory strategy
- Thorough knowledge of the drug development process and global submission process
- Demonstrated experience in working with the FDA
- Inter-dependant partnering skills, team-oriented with demonstrated ability to influence outcomes are necessary skills in the environment
- Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.
- Must be able to innovate, analyze and solve problems with minimal supervision and attention to detail
- Domestic and occasional International travel may be necessary
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.

C

Travel: Yes, 20 % of the Time

Zip Code:

07922
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