PAREXEL Hiring Regulatory Affairs Consultant

PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries.

Post : Regulatory Affairs Consultant

Job Description
Project Execution :
• Works effectively within a team environment
• Works within broad project guidelines as directed by the Project Lead or Technical SME
• With the guidance of the project Technical SME, demonstrates the ability to prioritize work to achieve specified project outcomes
• Capitalizes on opportunities to improve one’s own performance and seeks feedback from the Project Lead and colleagues
• Applies information provided by the Project Lead or senior colleagues to complete assigned project activities
• Produces quality work that meets the expectations of project lead and the client
• May serve as a Project Lead for small scale projects or a Work Stream Lead on larger projects
• When serving as a Project Lead with clear guidance and support from Line Manager
• Responsible for project planning and set-up and routinely interacts with the assigned Project Specialist (PS) or Project
• Manager (PM) to appropriately control the project (e.g. project set-up, forecasting and financial entries, invoicing, etc.)
• Functions as the main client contact and ensures accurate project reporting is in place
• Ensures that the project team delivers to meet the client expectations for quality and timeliness
• Ensures that appropriate risk identification and issue-escalation procedures are in place
• Ensures project specific training compliance of the project team
• Ensures and/or manages project financials including provision of accurate revenue forecasts
• Ensures that the project team understand and work to the scope of the contract
• Identifies new opportunities through Change In Scope or add-on business from existing work
• Ensures timely project close-out activities are completed
Consulting Activities and Relationship Management :
• Follows and implements the organization’s consulting models and methodologies under the guidance of the project lead and/or Technical SME
• Delivers a limited range of consulting services within personal area of expertise under the guidance of the Project Lead and/or Technical SME
• Completes assigned activities within project scope and objectives under the direction of the Project Lead and/or Technical SME
• Identifies project and internal issues to senior colleagues and Project Lead and/or Technical SME
• Interacts professionally at all working levels within a client organization and within PAREXEL
• Identifies project and/or client needs to the Project Lead and/or Technical SME
• Interactions result in clients expressing satisfaction with service provided

Business Development :
• Begin networking within the industry (i.e. maintain contacts and relationships with clients once engagements are complete)
• Communicates potential new business lead to PC management and account managers
PAREXEL-related Activities :
• Meets established metrics as specified in scorecard on an annual basis
• Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, training compliance, project deliverable archiving, participation in internal initiatives/projects
• Defines self-development activities with the support of management in order to keep current within the industry

Candidate Profile
• 8+ years’ experience in handling life cycle management of approved drug products (like- tablets (oral solids), syrups (oral liquids), parenterals (injections/ injectables for EU market.
• Good understanding of regulatory framework, including regional trends, for various types of applications and procedures
• Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.
• Working knowledge of EU/US regulatory procedures including post approval requirements. Knowledge of ROW markets regulatory legislations would be an added advantage
• Experience in handling CMC related health authority queries
• Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries.
• Liaise closely with cross-functional members with aligned product responsibilities.
• Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
• To prepare, review and submit safety variations to Health Authorities and also perform post Approval CMC related updates (where applicable).
• Prior working experience in Regulatory Information Management Systems like Veeva Vault would be desirable.
• Strong communications skills
• Ability to work independently.

Candidate Profile
• Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline
• 8+ years of experience in an industry-related environment
• Project management knowledge
• Client-focused approach to work
• Results orientation
• Teamwork and collaboration skills
• Consulting skills
• Excellent interpersonal and intercultural communication skills, both written and verbal
• Critical thinking and problem-solving skills
• Proficiency in local language and extensive working knowledge of the English language

Additional Information
Experience : 8+ years
Location : Bengaluru
Industry Type : Pharma / Healthcare / Clinical research
Job ID : R0000020439
Functional Area : Regulatory / Consulting
End Date : 20th July 2024