Associate Director / Senior Manager - Regulatory Job in Arisglobal

Role : Associate Director / Subject Matter Expert / Senior Manager

Job Location : Bangalore

Summary

Located in our Bangalore office, this position provides expert knowledge-based input to Product Management, Sales, Marketing and Global Delivery (GD) teams in support of the companys primary mission of expanding revenue and revenue opportunities, in line with overall company strategy.

The primary functionof Subject Matter Expertposition is to bring customer facing and industry / agency thought leadership experience to ArisGlobals product offerings in Regulatory domain. This position requires in-depth experience in Regulatory Affairs, particularly as it can be practically applied. A person that is practically and professionally involved both in the industry and academics would bring extra credibility to the position.

The ideal candidate will be a seasoned industry subject matter expert familiar with regulatory software like Regulatory Information Management Systems (RIMS), xEVMPD or IDMP systems, eCTD Publishing systems or regulatory document management systems (DMS) while working within industry. Additionally, she will have an established track record in engaging with customers, prospects and ArisGlobals identified industry partners to build product and/or solution strategy and elicit business requirements for regulatory affairs software products and/or services for Pharmaceutical, Biotechnology and/or Medical Devices domain.

The SME will support the companys ability to conceive and build market leading software products for the regulatory domain, by ensuring that industry trends, needs and business requirements are monitored, documented and communicated to internal teams like product management, engineering, services and marketing to equip them to design, build, sell and implement products in line with the companys overall strategy.

Essential Duties and Responsibilities

The SME will be part of the Product Management team of ArisGlobals Regulatory domain, reporting to the Regulatory Domain Product Owner and Head.

The designation at which the candidate will be hired is dependent on their level of experience and skills they bring to perform the following responsibilities.

• Be responsible for providing input into and driving the concept proposal and business requirement definition of ArisGlobals Regulatory domain software products.
• Working with the product management and PE team in India to ensure the application includes and is compliant with the latest regulations and guidelines.
• Working with ArisGlobals customers, prospects and industry partners, especially in Europe, India and Asia Pacific regions to ideate, gather, validate and document business needs and requirements by presenting software concept proposals, performing demonstration of prototyped software features, leading evaluation of the software sandbox with customers in a workshop
• Working as the Product SME/Champion with Client Partners and Customer Success managers in ensuring product adoption success, customer satisfaction and increased up/cross sell at top 50 pharma/device customer accounts assigned to her by regularly connecting with customers leadership team for sharing information on product strategy, vision and roadmap; by championing usage of product features in line with industry standard practices with end users at assigned customers; and by ensuring that their voice and sentiment is communicated back to product management, engineering and rest of the organization.
• Contribute in the Regulatory Industry Standard Practices (ISP) Forum initiatives including reviewing customer facing materials like business processes, standard configuration content, etc. and conducting web based and in person working groups with ISP members (customers and industry partners) to get required business inputs.
• Maintain familiarity with relevant regulatory issues, compliance, and guidance which may impact the solutions being presented.
• Maintain familiarity with competitive offerings in order to effectively position products and solutions in a competitive environment.
• Familiarize sales, pre-sales, services, marketing and customer support teams on a regular basis regarding new product features via internal product demonstrations, and share knowledge on market trends and competitive assessment.
• Support the Services team with questions related to new product functionality as the services team implements a product on a customer site.
• Share product and domain knowledge with Pre-Sales team to enable them to respond to RFPs, give product demonstration and prepare for bid-defence meetings, and if needed for big deals, also be present to engage with business leaders as a product champion who understands customers language.
• identify Product (Technical) Management to ensure that the gaps identified in the RFP/RFI responses are documented and planned in the roadmap.
• Work with Product (Technical) Management to ensure that the product gaps identified in the RFP/RFI responses, prospect demonstration and bid defence process are documented and planned in the product roadmap.

Requirements: Education and Experience

• Bachelors degree required
• Minimum of 10 years of total professional experience required
• Minimum 5 years of regulatory domain experience working within or with the pharmaceutical, medical device in multiple regulatory areas including dossier preparations, publishing and submissions, change management (including EU & US procedures), CMC, label and art work management, regulatory/manufacturing integrations, etc.
• Experience in either using, defining or demonstrating regulatory domain software products from at least one company like ArisGlobal, Parexel/Liquent, Veeva, Acuta/IQVIA, CuneSoft, Extedo, etc is a must.
• Software development life cycle (SDLC) process knowledge will be very good. Ideally should have worked in a software/services company or should have engaged with them as software/service vendors.
• Knowledge of standards like EVMPD, IDMP, UDI (GUDID, EUDAMED), eCTD standards.
• Experience in developing regulatory business processes that are optimized for achieving efficiencies and compliance is an advantage.

Soft Skills

The SME is a specialist role that requires self-motivation, the ability to communicate at all levels of an organization and an excellent understanding of both industry and software.

• Must work well with others in person or virtual and have a knack for understanding needs and problems.

• Proven ability to influence cross-functional teams at all levels of leadership is a must.
• Excellent communication skills both written and verbal required. Visual way of presenting nebulous ideas and complex concepts in a simple way is considered as a key aspect of communication in this role.
• Effective time management & multi-tasking skills.
• Ability to analyse and relate customer issues/requirements to ArisGlobal software solutions.
• Self-managed, self-starter, able to work in rapidly changing environment.
• High energy, detail oriented and creative individual.
• Ability to work both independently and cohesively in a team environment.

Working conditions

• Normal office environment
• 20% to 50% travel to Europe, Japan and occasionally within India (Mysore where Development Centre is present and Metros cities where client headquarters are present)
• Ability to work with global time zones