My Client is looking to hire a technology specialist who is strong in Architect and designing the process in technology space for regulatory and compliance role. 

Roles and responsibilities : 

 Responsible for the governance and enforcement of standardize solutions for projects, programme and continuous improvement initiatives related to REGULATORY solutions within the company.

Responsible to support information security team who is responsible for application life-cycle management for all applications confined to regulatory.

Supports the development of processes and template standards for changes to REGULATORY and related R&D/SQRC solutions.

Responsible for governing and enforcing these processes and standards during the life-cycle of REGULATORY IS change projects, infrastructure & network changes, major programme or continuous improvement activity

Responsible for Template Management and Solution Delivery support .

Responsible for people management and Development,stake holder management.

Desired Profile  :

Candidate with 12 to 15 years of with strong team handling experience preferably from Pharma, FMCG, Personal Hygiene and Consumer Healthcare sector.

Educated in Business discipline or Computer Science to degree level, or equivalent experience

Expertise in suite of REGULATORY Affairs & RIMS systems with at least 8-10 years of hands on experience in GAMP5, CSV, 21 CFR Part 11 and Annex 11 guidelines and related processes

Has to have hands on documentation experience (Validation Plan, Project Plan, Functional Risk Assessment, GxP Assessments, URS/BRD, FRS, Configuration & Design Specifications, Installation, Operational & Performance Qualifications (IQ, OQ & PQ), Training Plans, Release Notes, VSR etc.)

Expertise in Regulatory Affairs related guidelines (ICH, DIA, IDMP, xEVMPD, REACh, MedDRA dictionary etc.) applicable for regulatory authorities like FDA, EMA etc.

Agile software development methodologies e.g. Scrum, DSDM, XP, FDD, SAFe

At least 8-10 years of Microsoft Office Suite (MS Project and MS Visio experience is a plus) to Expert level.

Enterprise Regulatory Systems roll-out experience from both IT and Business perspective in the role of a Program or Project Manager

At least 4-6 years of core Regulatory Operations Management experience (for e.g. involvement in Regulatory submissions or executing submissions like NDA, ANDA, NeeS, IND etc., CMS activities, Dossier Management, working or reviewing Regulatory Intelligence reports, Medical Writing,