**General Scope and Summary**



The responsibilities of the Associate Director, Regulatory Project Management are to drive timelines and project management activities for major submissions such as NDAs and INDs and bridge communication between submission deliverable owners, Regulatory Affairs, and Regulatory Operations. Prior project management experience with NDA/BLA/MAA submissions and review is strongly preferred.



Candidates must be excited about Sage's mission and vision as well as Sage's core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun



**Roles and Responsibilities**



The Associate Director, Regulatory Project Management will:



+ Liaise between and partner with Regulatory Affairs and Regulatory Operations colleagues to ensure submission timelines are clearly communicated and met

+ Work cross-functionally with other areas to move regulatory projects and activities forward

+ Develop and actively manage project timelines as well as integrated submission project plans

+ Develop and maintain complex project plans, status reports, issue logs, and other project related tools

+ Prepare and distribute reports and trackers to communicate updates and project status

+ Create and update submission timelines, dashboards, forecasts, and other reports for sharing project status to teams

+ Capture metrics related to regulatory projects and submissions

+ Partner with IT to select and implement appropriate regulatory project management systems

+ Manage regulatory commitments

+ Develop submission dependencies and risk registries to identify and mitigate deviations in timelines

+ Lead initiatives to improve \"best practices,\" processes, and tools

+ Facilitate regulatory project management meetings

+ Maintain up to date knowledge of applicable health authority regulations, guidance documents, and ICH guidelines.



**Experience, Education and Specialized Knowledge and Skills**



Bachelor's degree in a relevant field, and 7 to 10 years of project management experience in the biotech/pharmaceutical industry is needed. Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to identify issues and raise to key stakeholders in order to develop relevant and realistic plans, programs and recommendations. Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.



**Basic Qualifications**



+ Proficiency in MS Project and associated project management tools (e.g. Office Timeline)

+ Solid understanding of regulatory submission eCTD process

+ Proficiency in Microsoft Word, Adobe Acrobat, and SharePoint

+ Experience with StartingPoint templates a plus



**Preferred Qualifications**



+ Excellent problem solving, organization, and planning

+ Strong interpersonal skills with the ability to develop important relationships with stakeholders

+ Strong communication, both written and verbal

+ Attention to detail

+ Ability to work independently, within a multi-disciplinary team, as well as with external partners and vendors

+ Ability to manage multiple tasks, demonstrate flexibility and ability to manage change



All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.



**Employment Type:**

Employee



**Number of Openings:**

1



**Job ID:**

R000318



**#Biotechnology #Careers #ThisIsSage**



All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.



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Associated topics: chief program officer, cpo, manage, manager, management, monitor, product manager, project manager, relationship manager, task

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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