Job Description :
R&D IT Regulatory Release Lead - The R&D IT Regulatory Release Lead will oversee the operational support enhancement requests which improve the functionality available to users of various Regulatory applications

The R&D IT Regulatory Release Lead will work with the Regulatory IT Support Lead and Principal Business Analyst to document and manage enhancement requests via the standard governance process to determine priority, approval and timing of implementation of the request(s The Regulatory Release Lead has responsibility for the health and success of these releases within a matrixed organization that has direct relationships with various groups in the business as well as IT.

This role requires the ability to:

Monitor, manage, and ensure delivery of projects in a deadline-driven environment.

Co-Lead requirements elicitation sessions

Develop process knowledge to translate to business and technical requirements

Author SDLC deliverables for review

Assist in testing preparation and implementation of enhancements

Support development of training materials, when applicable

Contribute to the creation of operational support documentation

Drive delivery and accountability of internal staff as well as vendors and third-party project managers

Enable early identification and appropriate escalation of risks and issues that require assistance, attention, or management resolution

Effectively communicate project status to Principal Business Analyst, verbally or in written form.

The Regulatory Release Lead is accountable for ensuring that the enhancements are delivered according to committed scope, approved budget, and target dates. The Regulatory Release Lead will ensure that internal staff, as well as vendors and third-party project managers, provide committed project deliverables with a high level of quality.


5+ years'' experience as a business analyst, with command of business analysis techniques & tools

Comfortable with project methodologies, and familiarity with tools including MS Project and Excel

Familiarity with use of and updating SharePoint sites

Strong interpersonal and teamwork skills as well as solid analytical and creative problem-solving skills

Ability to operate effectively in a matrix environment; team player yet able to work independently with minimal direction.

Excellent oral and written communication skills; able to organize and present ideas in a convincing and compelling manner.

Capable of multi-tasking across projects; highly organized

Familiarity with regulated systems (GxP, CFR 21 Part 11) and systems validation; Life Sciences, Biotech or pharmaceutical industry experience preferred.


BA or BS required

Certification in Computer Science, Business, or Life Sciences-related field