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Associate Director, Regulatory Affairs. Job in Cambridge, Massachusetts, United States in Biogen. Nelest.com
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Associate Director, Regulatory Affairs

col-narrow-left   

Job ID:

23120

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:

Associate Director, Regulatory Affairs

Job Description:

This position is in the Regulatory Development group and is focused on pre-approval products. Responsibilities include directing innovative global regulatory strategies for product development and approval. Compiling and managing regulatory documents, submissions, and compliance issues, representing the company with domestic and international regulatory authorities, contractors and corporate partners and providing regulatory support for various departments, projects, and teams/committees. May manage direct reports.


  • Responsible for directing global regulatory strategies for assigned projects and programs.
  • Identify and assess regulatory risks associated with product development. Define strategies to mitigate risks.
  • Provide regulatory guidance to company personnel throughout the research and development process.
  • Direct the organization and preparation of clear and effective submissions.
  • Prepare and deliver effective presentations for external and internal audiences.
  • Monitor and analyze appropriate regulatory agency activities in areas of interest to the company.
  • Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position.
  • Provide leadership on project teams and subcommittees in all areas of regulatory affairs and product development.
  • Allocate representation on relevant project teams
  • Provide input to Regulatory Senior Management teams.
  • Foster a global view as part of the whole regulatory team.


    Additional Functions:

  • Take steps to actively improve interdepartmental communications.
  • Actively participate in and contribute to outside relevant conferences, including organizing and delivering presentations.
  • Is likely to have presence on external regulatory committees/trade associations.
  • Direct global clinical and pre-clinical regulatory strategies.
  • Direct global life cycle management of products.
  • Develop and maintain highly capable and dedicated regulatory staff.
  • Guide subordinates in carrying out responsibilities.
  • Responsible for coordinating subordinate activities and career development.


    *LI-RD1
  • Job Requirements:

    Qualifications
    Experience
  • 8 years pharmaceutical/biotechnology industry experience with technical management experience, Minimum of 6 years in RA
  • Experience in interpretation of regulations, guidelines, policy statements, etc.,
  • Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements,
  • Experience in interfacing with relevant regulatory authorities
    Skills
  • Foster effective, positive interactions with regulatory agencies, and corporate partners.
  • Ability to lead and influence project teams, committees, etc. to attain group goals,
  • Demonstrate excellent leadership and communication skills,
  • Ability to represent the department in project teams, committees and external meetings.
  • Demonstrate strong organizational skills, including the ability to prioritize personal workload,
  • Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff,
  • Strong sensitivity for a multicultural/multinational environment.
  • Experience leading multi-disciplinary teams,
  • Well organized, detail oriented, effective written and oral communication skills,
  • Education
  • B.S. degree required, science degree preferred
  • 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

    Associate Director, Regulatory Affairs

    col-narrow-left   

    Job ID:

    23120

    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:

    Associate Director, Regulatory Affairs

    Job Description:

    This position is in the Regulatory Development group and is focused on pre-approval products. Responsibilities include directing innovative global regulatory strategies for product development and approval. Compiling and managing regulatory documents, submissions, and compliance issues, representing the company with domestic and international regulatory authorities, contractors and corporate partners and providing regulatory support for various departments, projects, and teams/committees. May manage direct reports.


  • Responsible for directing global regulatory strategies for assigned projects and programs.
  • Identify and assess regulatory risks associated with product development. Define strategies to mitigate risks.
  • Provide regulatory guidance to company personnel throughout the research and development process.
  • Direct the organization and preparation of clear and effective submissions.
  • Prepare and deliver effective presentations for external and internal audiences.
  • Monitor and analyze appropriate regulatory agency activities in areas of interest to the company.
  • Build and maintain excellent relationships with relevant regulatory agencies, contractors and corporate partners while negotiating company position.
  • Provide leadership on project teams and subcommittees in all areas of regulatory affairs and product development.
  • Allocate representation on relevant project teams
  • Provide input to Regulatory Senior Management teams.
  • Foster a global view as part of the whole regulatory team.


    Additional Functions:

  • Take steps to actively improve interdepartmental communications.
  • Actively participate in and contribute to outside relevant conferences, including organizing and delivering presentations.
  • Is likely to have presence on external regulatory committees/trade associations.
  • Direct global clinical and pre-clinical regulatory strategies.
  • Direct global life cycle management of products.
  • Develop and maintain highly capable and dedicated regulatory staff.
  • Guide subordinates in carrying out responsibilities.
  • Responsible for coordinating subordinate activities and career development.


    *LI-RD1
  • Job Requirements:

    Qualifications
    Experience
  • 8 years pharmaceutical/biotechnology industry experience with technical management experience, Minimum of 6 years in RA
  • Experience in interpretation of regulations, guidelines, policy statements, etc.,
  • Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements,
  • Experience in interfacing with relevant regulatory authorities
    Skills
  • Foster effective, positive interactions with regulatory agencies, and corporate partners.
  • Ability to lead and influence project teams, committees, etc. to attain group goals,
  • Demonstrate excellent leadership and communication skills,
  • Ability to represent the department in project teams, committees and external meetings.
  • Demonstrate strong organizational skills, including the ability to prioritize personal workload,
  • Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff,
  • Strong sensitivity for a multicultural/multinational environment.
  • Experience leading multi-disciplinary teams,
  • Well organized, detail oriented, effective written and oral communication skills,
  • Education
  • B.S. degree required, science degree preferred
  • 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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