Apellis Pharmaceuticals, Inc.
Manager, Global Submission Operations
Apellis Pharmaceuticals, Inc., Waltham, Massachusetts, United States, 02254
Position Summary:
The Manager, Global Submission Operations (GSO), a sub-function of Global Regulatory Operations (GRO), is accountable for managing the routine and non-routine submission activity for Apellis' portfolio. The Manager, in collaboration with the Regulatory Lead, plans and prepares high quality global submissions, in-house or via publishing vendor, ensuring timely delivery of compliant submissions to health authorities. Provide technical expertise to cross-functional submission project teams, to promote and bring excellence in planning, preparation and delivery of high-quality regulatory submissions, and acts as the primary point of contact for project and/or submission teams for major submissions. Support the Global Submissions Operations Lead or other members of the Regulatory Operations and Regulatory Affairs, in activities related to setting standards, best practices, metrics collection, developing new procedures and work instructions,and lessons learned dissemination and will assist in other activities as needed. It is expected that Manager, will be deeply involved in publishing and submission management and will contribute to archiving and information management activities of the RA Department, along with implementation of systems and tools, if needed.
Key Responsibilities Include:
Provide operational oversight for the planning, preparation, publishing, validation, and timely submission of assigned applications (IND, NDA, MAA, etc.), updates, amendments, and variations to global healthauthorities.
Monitor the development of new regulatory requirements or guidance documents and provide advice to GRO and submission project team on the business impact.
Support development and implementation of standards and best practices for dossier management, publishing, archiving and submission process for global regulatory authorities.
Oversee compliant and timely archiving of regulatory submissions and correspondences for Apellis compounds and generation of KPIs.
Manage activities of the publishing vendors in preparation of high-quality submission packages and their timely delivery to health authorities, if needed.
Manage cross-functional global submission teams in the delivery of compliant submission components according to agreed standards, requirements, timelines, and processes.
Participate and share lessons learned sessions to encourage process improvement and efficiencies within and across submission project teams.
Negotiate and agree on realistic dates for document handoffs in collaboration with the authors and publishers (in-house and vendors).
Manage publishing and dossier compilation of routine and non-routine eCTD and other submissions, as needed (and as assigned)
In collaboration with the regulatory leads, manage the development and maintenance of a global submission content plan and tracking the components from authoring to approval, publishing, and QC.
As a global submissions expert, ensure the project team has sufficient awareness and knowledge of esubmissions standards and formats (eCTD, NeeS, etc.) and lifecycle management concepts and communicate regional differences as appropriate within the context of global submission preparation.
Manage updating and distribution of the Global Submission Planner and Tracker information.
Participate in validation activities (requirements gathering, User Acceptance Testing, etc.) for the implementation of technology systems, as necessary (Publishing, EDMS, etc.)
Train other publishers and contractors on Apellis standards and publishing systems.
Education, Registration & Certification:
Bachelor's degree in a scientific or technical discipline is required; equivalent experience may be accepted. Master's degree preferred
Experience:
A minimum of 6 years of experience in regulatory affairs/operations within the pharmaceutical industry.
Strong verbal and written communication and presentation skills.
Strong training skill is a plus.
Very strong interpersonal skills and ability to build relationships with cross functional teams.
Expertise in CTD/eCTD structure and requirements and an excellent understanding of submission requirements for global submission types (IND, NDA, MAA, etc.).
Solid experience in publishing and compilation of eCTD submissions for US and EU filings is required.
Excellent knowledge of Microsoft Office suite, Adobe Acrobat and Plug-Ins (PDFTools, ISIToolbox), electronic document management systems (Veeva, SP, BOX),eCTD publishing, validation and viewing tools. Solid experience and knowledge of SharePoint technology is desired.
In-depth knowledge of StartingPoint authoring templates. Will act as a trainee for new users.
Demonstrated project management, organizational and planning skills.
Ability to multi-task, attention to details, and end-result driven with meeting deadlines.
Ability to work independently (with minimal supervision), as well as work in a team environment with changing timelines and priorities.
Must be able to adhere to strict project timelines, and to advise teams and management of impacts and changes in project timelines.
Good understanding of the internal and external interdependencies among submission activities that could have an impact on the schedule or quality of a submission and manage to ensure that submission goals are met on a timely manner and to the highest quality.
Physical Demands and Work Environment:
This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary. This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
Travel Requirements:
Up to 20% travel expected.
Benefits and Perks:
Apellis offers a great benefit package which includes: health insurance with
full premium coverage , 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more!
Visit https://apellis.com/careers/ to learn more.
Company Background:
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.
For more information, please visit http://apellis.com or follow us on Twitter and LinkedIn
EEO Statement:
Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.
For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
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The Manager, Global Submission Operations (GSO), a sub-function of Global Regulatory Operations (GRO), is accountable for managing the routine and non-routine submission activity for Apellis' portfolio. The Manager, in collaboration with the Regulatory Lead, plans and prepares high quality global submissions, in-house or via publishing vendor, ensuring timely delivery of compliant submissions to health authorities. Provide technical expertise to cross-functional submission project teams, to promote and bring excellence in planning, preparation and delivery of high-quality regulatory submissions, and acts as the primary point of contact for project and/or submission teams for major submissions. Support the Global Submissions Operations Lead or other members of the Regulatory Operations and Regulatory Affairs, in activities related to setting standards, best practices, metrics collection, developing new procedures and work instructions,and lessons learned dissemination and will assist in other activities as needed. It is expected that Manager, will be deeply involved in publishing and submission management and will contribute to archiving and information management activities of the RA Department, along with implementation of systems and tools, if needed.
Key Responsibilities Include:
Provide operational oversight for the planning, preparation, publishing, validation, and timely submission of assigned applications (IND, NDA, MAA, etc.), updates, amendments, and variations to global healthauthorities.
Monitor the development of new regulatory requirements or guidance documents and provide advice to GRO and submission project team on the business impact.
Support development and implementation of standards and best practices for dossier management, publishing, archiving and submission process for global regulatory authorities.
Oversee compliant and timely archiving of regulatory submissions and correspondences for Apellis compounds and generation of KPIs.
Manage activities of the publishing vendors in preparation of high-quality submission packages and their timely delivery to health authorities, if needed.
Manage cross-functional global submission teams in the delivery of compliant submission components according to agreed standards, requirements, timelines, and processes.
Participate and share lessons learned sessions to encourage process improvement and efficiencies within and across submission project teams.
Negotiate and agree on realistic dates for document handoffs in collaboration with the authors and publishers (in-house and vendors).
Manage publishing and dossier compilation of routine and non-routine eCTD and other submissions, as needed (and as assigned)
In collaboration with the regulatory leads, manage the development and maintenance of a global submission content plan and tracking the components from authoring to approval, publishing, and QC.
As a global submissions expert, ensure the project team has sufficient awareness and knowledge of esubmissions standards and formats (eCTD, NeeS, etc.) and lifecycle management concepts and communicate regional differences as appropriate within the context of global submission preparation.
Manage updating and distribution of the Global Submission Planner and Tracker information.
Participate in validation activities (requirements gathering, User Acceptance Testing, etc.) for the implementation of technology systems, as necessary (Publishing, EDMS, etc.)
Train other publishers and contractors on Apellis standards and publishing systems.
Education, Registration & Certification:
Bachelor's degree in a scientific or technical discipline is required; equivalent experience may be accepted. Master's degree preferred
Experience:
A minimum of 6 years of experience in regulatory affairs/operations within the pharmaceutical industry.
Strong verbal and written communication and presentation skills.
Strong training skill is a plus.
Very strong interpersonal skills and ability to build relationships with cross functional teams.
Expertise in CTD/eCTD structure and requirements and an excellent understanding of submission requirements for global submission types (IND, NDA, MAA, etc.).
Solid experience in publishing and compilation of eCTD submissions for US and EU filings is required.
Excellent knowledge of Microsoft Office suite, Adobe Acrobat and Plug-Ins (PDFTools, ISIToolbox), electronic document management systems (Veeva, SP, BOX),eCTD publishing, validation and viewing tools. Solid experience and knowledge of SharePoint technology is desired.
In-depth knowledge of StartingPoint authoring templates. Will act as a trainee for new users.
Demonstrated project management, organizational and planning skills.
Ability to multi-task, attention to details, and end-result driven with meeting deadlines.
Ability to work independently (with minimal supervision), as well as work in a team environment with changing timelines and priorities.
Must be able to adhere to strict project timelines, and to advise teams and management of impacts and changes in project timelines.
Good understanding of the internal and external interdependencies among submission activities that could have an impact on the schedule or quality of a submission and manage to ensure that submission goals are met on a timely manner and to the highest quality.
Physical Demands and Work Environment:
This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets and bend or stand on a stool as necessary. This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
Travel Requirements:
Up to 20% travel expected.
Benefits and Perks:
Apellis offers a great benefit package which includes: health insurance with
full premium coverage , 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more!
Visit https://apellis.com/careers/ to learn more.
Company Background:
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.
For more information, please visit http://apellis.com or follow us on Twitter and LinkedIn
EEO Statement:
Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.
For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.
Other Duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
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