Query SELECT `session_id` FROM `user_session_data_storage` WHERE `session_id` = ? : 
Statement could not be executed (HY000 - 145 - Table './db05/user_session_data_storage' is marked as crashed and should be repaired)
Query INSERT INTO `user_session_data_storage` SET `last_activity` = NOW(), `session_id` = ? : 
Statement could not be executed (HY000 - 145 - Table './db05/user_session_data_storage' is marked as crashed and should be repaired)
Associate Director, Regulatory Affairs (Biologics CMC). Job in Kenilworth, New Jersey, United States in Merck & Co., Inc.. Nelest.com
Home  |  Contact  |  About Us
|   Register  |  Sign In

Associate Director, Regulatory Affairs (Biologics CMC)

col-narrow-left   

Job ID:

22110

Location:

Kenilworth, NJ 

Job function:

Legal Services
col-narrow-right   

Posted:

03.05.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Associate Director, Regulatory Affairs (Biologics CMC)

Job Description:

Description Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. As an individual contributor uses facilitative leadership skills to lead team within CMC Biologics responsible for the preparation of new filing applications and maintenance of chemistry, manufacturing and control (CMC) documentation for worldwide registration. Provides an in-depth breadth of experience in regulatory affairs, both domestically and internationally, in support of development of pipeline biological product development throughout various phases (IND/IMPD/Information Amendment), new product product global registration (BLA/MAA), life-cycle management and post-approval change supplements/variations to existing biologics product license applications (BLAs) or marketing authorization applications (MAAs) worldwide. Participates in and/or leads cross-functional and functional teams, including but not limited to, IDST, functional working groups, global regulatory team, submission team, product development team. Provide sound regulatory guidance and strategy to support the product development/registration/lifecycle management. Assures that filed information on the current manufacturing and testing procedures is kept updated for each product using appropriate departmental systems Ensures consistency in practices, champions best practices and promotes operational excellence

Travel: Yes, 10 % of the Time Description Associate Director, Regulatory Affairs (Biologics CMC)-REG002222 Description Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. As an individual contributor uses facilitative leadership skills to lead team within CMC Biologics responsible for the preparation of new filing applications and maintenance of chemistry, manufacturing and control (CMC) documentation for worldwide registration. Provides an in-depth breadth of experience in regulatory affairs, both domestically and internationally, in support of development of pipeline biological product development throughout various phases (IND/IMPD/Information Amendment), new product product global registration (BLA/MAA), life-cycle management and post-approval change supplements/variations to existing biologics product license applications (BLAs) or marketing authorization applications (MAAs) worldwide. Participates in and/or leads cross-functional and functional teams, including but not limited to, IDST, functional working groups, global regulatory team, submission team, product development team. Provide sound regulatory guidance and strategy to support the product development/registration/lifecycle management. Assures that filed information on the current manufacturing and testing procedures is kept updated for each product using appropriate departmental systems Ensures consistency in practices, champions best practices and promotes operational excellence
Qualifications Education:
  • The candidate must possess an advanced degree in science (Ph.D. preferred)

Job Requirements:

Qualifications Education:
  • The candidate must possess an advanced degree in science (Ph.D. preferred)


Required:
  • At least 5 years biologics experience within the pharmaceutical industry.
  • The ideal candidate will have strong experience in Regulatory CMC, as well as development, manufacturing or quality assurance experience .
  • Prior Biologics License Application (BLA) or Investigational New Drug (IND) experience in a leadership role. Demonstrated sound understanding of related fields (e.g., manufacturing, process development, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
  • Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
  • Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills.
  • Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
  • Demonstrated effective leadership, project management, communication, interpersonal and negotiating skills.
  • Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.
  • The candidate must be proficient in English, additional language skills are a plus. The candidate may be required to travel on a periodic basis.


Preferred:
  • At least seven (7) years of relevant experience in support of biologics
  • Preferred fields of study include Biochemistry, Molecular Biology, Engineering, Microbiology, or Virology


Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at staffingaadar@merck.com. Search Firm Representatives Please Read Carefully: Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. Visa sponsorship is not available for this position. For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement? Merck is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.

Zip Code:

7033

Company Info
Merck & Co., Inc.

Kenilworth, NJ, United States

Phone:
Web Site: merck.com

Company Profile

Company Info


Merck & Co., Inc.
Kenilworth, NJ, United States
Phone:
Web Site: merck.com

Associate Director, Regulatory Affairs (Biologics CMC)

col-narrow-left   

Job ID:

22110

Location:

Kenilworth, NJ 

Job function:

Legal Services
col-narrow-right   

Posted:

03.05.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Associate Director, Regulatory Affairs (Biologics CMC)

Job Description:

Description Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. As an individual contributor uses facilitative leadership skills to lead team within CMC Biologics responsible for the preparation of new filing applications and maintenance of chemistry, manufacturing and control (CMC) documentation for worldwide registration. Provides an in-depth breadth of experience in regulatory affairs, both domestically and internationally, in support of development of pipeline biological product development throughout various phases (IND/IMPD/Information Amendment), new product product global registration (BLA/MAA), life-cycle management and post-approval change supplements/variations to existing biologics product license applications (BLAs) or marketing authorization applications (MAAs) worldwide. Participates in and/or leads cross-functional and functional teams, including but not limited to, IDST, functional working groups, global regulatory team, submission team, product development team. Provide sound regulatory guidance and strategy to support the product development/registration/lifecycle management. Assures that filed information on the current manufacturing and testing procedures is kept updated for each product using appropriate departmental systems Ensures consistency in practices, champions best practices and promotes operational excellence

Travel: Yes, 10 % of the Time Description Associate Director, Regulatory Affairs (Biologics CMC)-REG002222 Description Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company - one that is ready to help create a healthier future for all of us. Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. As an individual contributor uses facilitative leadership skills to lead team within CMC Biologics responsible for the preparation of new filing applications and maintenance of chemistry, manufacturing and control (CMC) documentation for worldwide registration. Provides an in-depth breadth of experience in regulatory affairs, both domestically and internationally, in support of development of pipeline biological product development throughout various phases (IND/IMPD/Information Amendment), new product product global registration (BLA/MAA), life-cycle management and post-approval change supplements/variations to existing biologics product license applications (BLAs) or marketing authorization applications (MAAs) worldwide. Participates in and/or leads cross-functional and functional teams, including but not limited to, IDST, functional working groups, global regulatory team, submission team, product development team. Provide sound regulatory guidance and strategy to support the product development/registration/lifecycle management. Assures that filed information on the current manufacturing and testing procedures is kept updated for each product using appropriate departmental systems Ensures consistency in practices, champions best practices and promotes operational excellence
Qualifications Education:
  • The candidate must possess an advanced degree in science (Ph.D. preferred)

Job Requirements:

Qualifications Education:
  • The candidate must possess an advanced degree in science (Ph.D. preferred)


Required:
  • At least 5 years biologics experience within the pharmaceutical industry.
  • The ideal candidate will have strong experience in Regulatory CMC, as well as development, manufacturing or quality assurance experience .
  • Prior Biologics License Application (BLA) or Investigational New Drug (IND) experience in a leadership role. Demonstrated sound understanding of related fields (e.g., manufacturing, process development, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
  • Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
  • Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills.
  • Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
  • Demonstrated effective leadership, project management, communication, interpersonal and negotiating skills.
  • Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.
  • The candidate must be proficient in English, additional language skills are a plus. The candidate may be required to travel on a periodic basis.


Preferred:
  • At least seven (7) years of relevant experience in support of biologics
  • Preferred fields of study include Biochemistry, Molecular Biology, Engineering, Microbiology, or Virology


Our employees are the key to our company's success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company's benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at staffingaadar@merck.com. Search Firm Representatives Please Read Carefully: Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. Visa sponsorship is not available for this position. For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement? Merck is an equal opportunity employer, Minority/Female/Disability/Veteran - proudly embracing diversity in all of its manifestations.

Zip Code:

7033
Copyright © 2016 NELEST.COM All rights reserved