Regulatory Operations Contractor

2 months ago

Boston, United States Beacon Hill Life Sciences - Boston Full time
Job DescriptionJob Description

Regulatory Operations Contractor

Location(Boston): Can be fully remote; must work EST hours - (if local maybe come in monthly for C&C days)

Contract Term: Contract through EOY with possible extension

 

  • Should have strong Word, PDF, Adobe skills – going through documentation, cleaning it up, getting approvals, submissions, sending out to Reg
  • Document publishing is key, submission publishing with document publishing is even better
  • Supported preparation of NDA and created project plans for NDA modules
  • Extensive bookmarking and hyperlinking, taking all the submission documents and hyperlinking all the supporting study data and reports.

 

Position Summary:

Reporting to the Senior Director, Regulatory Operations, the Regulatory Operations Contractor will assist with the development and implementation of systems and procedures used to support regulatory submission activities including eCTD production, document publishing, and document management. This position will also be responsible for participating in day-to-day Regulatory Operations activities in support of the company’s goals.

Responsibilities:

·       Represent Regulatory Operations by participating on assigned teams to support submission scheduling and ensure coordination of system development activities;

·       Coordinate and participate in the production of electronic regulatory submissions;

·       Support and conduct cross functional training on submission standards, procedures, and systems as required;

·       Support compliance with worldwide submission regulations and guidelines.

Qualifications:

·       Experience compiling electronic submissions and in electronic document publishing;

·       Experience compiling IND, NDA/BLA, and CTD submissions;

·       Understanding of eCTD submission requirements;

·       Excellent communication and interpersonal skills;

·       Demonstrated ability to work well with cross functional teams;

·       Demonstrated ability to manage priorities and work under tight deadlines;

·       Demonstrated skills managing timelines and organizing supporting resources;

·       2+ years of pharmaceutical industry experience preferred;

·       2+ years of experience compiling electronic submissions preferred;

·       Proficient with Microsoft Office products and Adobe Acrobat.

 

Company DescriptionBeacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/

Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.Company DescriptionBeacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.\r
\r
If you would like to complete our voluntary self-identification form, please click here or copy and paste the following link into an open window in your browser: https://jobs.beaconhillstaffing.com/eeoc/\r
\r
Completion of this form is voluntary and will not affect your opportunity for employment, or the terms or conditions of your employment. This form will be used for reporting purposes only and will be kept separate from all other records.

  • Director Regulatory Operations

    4 days ago

    Boston, United States EPM Scientific Full time

    Title: Director, Regulatory OperationsA growing biotechnology company is seeking a Director of Regulatory Operations to lead and manage the regulatory strategy and operations for global submissions and systems projects in a dynamic, rapidly evolving environment. This organization is focused on developing innovative therapies for rare and underserved...

  • Director Regulatory Operations

    5 days ago

    Boston, United States EPM Scientific Full time

    Title: Director, Regulatory OperationsA growing biotechnology company is seeking a Director of Regulatory Operations to lead and manage the regulatory strategy and operations for global submissions and systems projects in a dynamic, rapidly evolving environment. This organization is focused on developing innovative therapies for rare and underserved...

  • Engineer (Biotech)

    1 month ago

    Boston, United States Regulatory Connect Full time

    Job Title Engineer (Biologics)Location - MAContractWe are seeking a dynamic and motivated Process Engineer to join our clients team. In this role, you will lead critical manufacturing process initiatives, driving process efficiencies and quality improvements. If you have a passion for biologics or antibody drug conjugation manufacturing and thrive in a...

  • Head, Global Regulatory Operations

    2 days ago

    Boston, United States Takeda Pharmaceutical Full time

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice...

  • Regulatory Operations Specialist

    4 weeks ago

    Boston, Massachusetts, United States Beacon Hill Life Sciences - Boston Full time

    Beacon Hill Life Sciences - Boston is seeking a skilled Regulatory Operations Specialist to join their team. This role will focus on ECTD productions, document publishing, and document management. As a Regulatory Operations Specialist, you will be responsible for representing the company by participating on assigned teams to support submission scheduling and...

  • Head, Global Regulatory Operations

    1 week ago

    Boston, United States Takeda Pharmaceutical Full time

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...

  • EPM Scientific | Director Regulatory Operations | boston, ma

    3 days ago

    boston, United States EPM Scientific Full time

    Title: Director, Regulatory OperationsA growing biotechnology company is seeking a Director of Regulatory Operations to lead and manage the regulatory strategy and operations for global submissions and systems projects in a dynamic, rapidly evolving environment. This organization is focused on developing innovative therapies for rare and underserved...

  • EPM Scientific | Director Regulatory Operations | boston, ma

    5 days ago

    boston, United States EPM Scientific Full time

    Title: Director, Regulatory OperationsA growing biotechnology company is seeking a Director of Regulatory Operations to lead and manage the regulatory strategy and operations for global submissions and systems projects in a dynamic, rapidly evolving environment. This organization is focused on developing innovative therapies for rare and underserved...

  • Associate Director of Regulatory Medical Writing

    2 weeks ago

    boston, United States Planet Pharma Full time

    Planet Pharma's biopharma client is looking for an Associate Director of Medical Writing to contribute to the development of complex clinical, nonclinical, and safety documents for regulatory submissions. This individual will also develop critical infrastructure for the maturation of the department.This individual will contribute to and execute the overall...

  • Associate Director of Regulatory Medical Writing

    2 weeks ago

    Boston, United States Planet Pharma Full time

    Planet Pharma's biopharma client is looking for an Associate Director of Medical Writing to contribute to the development of complex clinical, nonclinical, and safety documents for regulatory submissions. This individual will also develop critical infrastructure for the maturation of the department.This individual will contribute to and execute the overall...

  • Associate Director of Regulatory Medical Writing

    2 weeks ago

    Boston, United States Planet Pharma Full time

    Planet Pharma's biopharma client is looking for an Associate Director of Medical Writing to contribute to the development of complex clinical, nonclinical, and safety documents for regulatory submissions. This individual will also develop critical infrastructure for the maturation of the department.This individual will contribute to and execute the overall...

  • Legal Counsel

    4 weeks ago

    Boston, United States Boston Consulting Group Full time

    WHAT YOU'LL DOBCG is partnering with our clients to tackle some of the world’s biggest and most pressing challenges. Grounded by our values and guided by our purpose, we are unlocking the potential of those who advance the world. Our Global Legal Team is a key enabler of our firm’s success, helping to drive impact and progress across several important...

  • Legal Counsel

    4 weeks ago

    Boston, United States Boston Consulting Group Full time

    WHAT YOU'LL DOBCG is partnering with our clients to tackle some of the world’s biggest and most pressing challenges. Grounded by our values and guided by our purpose, we are unlocking the potential of those who advance the world. Our Global Legal Team is a key enabler of our firm’s success, helping to drive impact and progress across several important...

  • Legal Counsel

    2 months ago

    Boston, United States Boston Consulting Group Full time

    WHAT YOU'LL DOBCG is partnering with our clients to tackle some of the world’s biggest and most pressing challenges. Grounded by our values and guided by our purpose, we are unlocking the potential of those who advance the world. Our Global Legal Team is a key enabler of our firm’s success, helping to drive impact and progress across several important...

  • Regulatory Affairs Director

    4 weeks ago

    Boston, Massachusetts, United States Fairway Consulting Group Full time

    Job Summary:Fairway Consulting Group is seeking a highly experienced Regulatory Affairs Director to lead our client's global regulatory strategy and execution on development programs. The ideal candidate will have a comprehensive knowledge of the drug development process, global regulations and guidelines, and a comprehensive understanding of global...

  • Regulatory Affairs Consultant

    3 days ago

    Boston, Massachusetts, United States Capgemini Full time

    Regulatory Affairs ConsultantCapgemini is seeking a highly skilled Regulatory Affairs Consultant to manage and optimize our regulatory information management processes using the Veeva Vault RIM platform. The ideal candidate will have a strong background in regulatory affairs, experience with Veeva solutions, and a deep understanding of compliance...

  • Regulatory Affairs Specialist

    4 days ago

    Boston, United States PathAI Full time

    PathAI is on a mission to improve patient outcomes with AI-powered pathology. We are transforming traditional pathology methods into powerful, new technologies. These innovations in pathology can help accelerate drug development, improve confidence in the accuracy of diagnosis, and get life-saving therapies to patients more quickly. At PathAI, you‘ll work...

  • Senior Regulatory Affairs Director, Global Regulatory Strategy

    3 weeks ago

    Boston, United States AstraZeneca Full time

    Position Summary: The Senior Regulatory Affairs Director (RAD), a member of the Global Regulatory Strategy team, will be responsible for overseeing the development, implementation, and execution of regulatory activities for assigned products and regulatory jurisdictions with a goal of achieving registrational approval from governmental authorities and post...

  • Document Control Specialist, Contractor I

    4 weeks ago

    Boston, Massachusetts, United States Integrated Resources Full time

    Job Summary:Integrated Resources is seeking a skilled Document Control Specialist, Contractor I to join our team. As a key member of our documentation team, you will be responsible for the processing, tracking, and archiving of GxP documentation, both hardcopy and electronic. This role will also involve managing physical and electronic documentation,...

  • Regulatory Compliance Director

    4 weeks ago

    Boston, Massachusetts, United States Fidelity Investments Full time

    Job Description:Director, FDAS Compliance - Regulatory Relationship and Exam ManagementThe RoleAs a member of the Fidelity Digital Asset Services, LLC ('FDAS') Compliance team, you will serve as an informed and trusted business partner, who promotes a culture of ethical conduct and commitment to compliance, regulatory and legal obligations. In this role on...