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Sr Manager, Regulatory Affairs. Job in Cambridge, Massachusetts, United States in Biogen. Nelest.com
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Sr Manager, Regulatory Affairs

col-narrow-left   

Job ID:

23122

Location:

Cambridge, MA 

Job function:

Business Development, Legal Services
col-narrow-right   

Posted:

03.11.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Sr Manager, Regulatory Affairs

Job Description:

Position Summary:
Responsible for actively contributing to the development and implementation of regulatory strategy for specific projects, serving as the regulatory representative on relevant project teams, and serving as the regulatory contact with relevant regulatory authorities, as appropriate.

Duties and Responsibilities:
  • Responsible for actively contributing to the development and implementation of regulatory strategy for assigned projects and programs.
  • Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects or programs.
  • Identify and assess regulatory risks for assigned projects or programs.
  • Prepare and deliver effective presentations for external and internal audiences.
  • Contact regulatory agencies relevant to assigned projects or programs, as appropriate.
  • Participate and contribute in Health Authority meetings.
  • Represent regulatory on relevant project teams.
  • Mentor other Regulatory staff members.
  • Contribute to the development and implementation of clinical and pre-clinical regulatory strategy for projects in all stages of development (pre-IND/IMPD through commercial).
  • Contribute to life-cycle management of products.
  • Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals.
  • Represent the department in project teams.

    *LI-RD1
  • Job Requirements:

    Qualifications
  • Demonstrate excellent communication and influencing skills internally and externally at all levels of the organization.
  • Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload.
  • Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.
  • Demonstrate effective cross functional and cross cultural skills including influence at external industry meetings.
  • Demonstrate strategic thinking, change agent leadership and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and communicate these effectively.
  • Experience in interfacing with relevant regulatory authorities.
  • Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
  • Knowledge and understanding of applicable regulations.
  • Experience in interpretation of regulations, guidelines, policy statements, etc.
  • Experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project.
  • Good knowledge of GCPs and GLPs.
  • Education
  • BA/BS/University degree required, Life/Health Sciences preferred.
  • Ideal candidate will have a minimum of 7 years regulatory or relevant industry experience.
  • About BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic conditions and autoimmune diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.

    Founded in 1978, Biogen is one of the world's oldest biotechnology companies. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for secondary progressive MS, Alzheimer's Disease, spinal muscular atrophy, lupus and amyotrophic lateral sclerosis (ALS), amongst others.

    With approximately 7,500 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

    Please be advised that all legitimate correspondence from a Biogen employee will come from '@biogen.com' or '@biogenidec.com' email accounts.

    Zip Code:

    02142

    Company Info
    Biogen

    Cambridge, MA, United States

    Phone: +1 781-464-3260, +1 781-464-3260
    Web Site: www.biogene.com

    Company Profile

    Company Info


    Biogen
    Cambridge, MA, United States
    Phone: +1 781-464-3260, +1 781-464-3260
    Web Site: www.biogene.com

    Sr Manager, Regulatory Affairs

    col-narrow-left   

    Job ID:

    23122

    Location:

    Cambridge, MA 

    Job function:

    Business Development, Legal Services
    col-narrow-right   

    Posted:

    03.11.2016

    Employment Type:

    Full time

    Industry:

    Healthcare / Pharma
    col-wide   

    Title:

    Sr Manager, Regulatory Affairs

    Job Description:

    Position Summary:
    Responsible for actively contributing to the development and implementation of regulatory strategy for specific projects, serving as the regulatory representative on relevant project teams, and serving as the regulatory contact with relevant regulatory authorities, as appropriate.

    Duties and Responsibilities:
  • Responsible for actively contributing to the development and implementation of regulatory strategy for assigned projects and programs.
  • Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects or programs.
  • Identify and assess regulatory risks for assigned projects or programs.
  • Prepare and deliver effective presentations for external and internal audiences.
  • Contact regulatory agencies relevant to assigned projects or programs, as appropriate.
  • Participate and contribute in Health Authority meetings.
  • Represent regulatory on relevant project teams.
  • Mentor other Regulatory staff members.
  • Contribute to the development and implementation of clinical and pre-clinical regulatory strategy for projects in all stages of development (pre-IND/IMPD through commercial).
  • Contribute to life-cycle management of products.
  • Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals.
  • Represent the department in project teams.

    *LI-RD1
  • Job Requirements:

    Qualifications
  • Demonstrate excellent communication and influencing skills internally and externally at all levels of the organization.
  • Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload.
  • Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.
  • Demonstrate effective cross functional and cross cultural skills including influence at external industry meetings.
  • Demonstrate strategic thinking, change agent leadership and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and communicate these effectively.
  • Experience in interfacing with relevant regulatory authorities.
  • Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
  • Knowledge and understanding of applicable regulations.
  • Experience in interpretation of regulations, guidelines, policy statements, etc.
  • Experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project.
  • Good knowledge of GCPs and GLPs.
  • Education
  • BA/BS/University degree required, Life/Health Sciences preferred.
  • Ideal candidate will have a minimum of 7 years regulatory or relevant industry experience.
  • About BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic conditions and autoimmune diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.

    Founded in 1978, Biogen is one of the world's oldest biotechnology companies. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for secondary progressive MS, Alzheimer's Disease, spinal muscular atrophy, lupus and amyotrophic lateral sclerosis (ALS), amongst others.

    With approximately 7,500 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

    Please be advised that all legitimate correspondence from a Biogen employee will come from '@biogen.com' or '@biogenidec.com' email accounts.

    Zip Code:

    02142
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