PAREXEL looking for Senior Regulatory Affairs Associate

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 : Senior Regulatory Affairs Associate

Job Description
Project Execution
• Works effectively within a team environment but may work independently delivering services within their area of competence
• Works within broad project guidelines as directed by the project lead and/or technical SMEs
• Takes initiative to prioritize work to achieve specified project outcomes while confirming alignment with project lead and line manager
• 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
• 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 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 with an understanding of issues which may impact project profitability 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 and provides proposed solutions
• 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 and collaborates with senior staff to define a proposed solution
• Interactions result in clients expressing satisfaction with service provided
• May assist in preparing and/ or delivering a presentation with the support of senior colleagues
• Identifies and alerts PC management to opportunities for follow-on business or necessary changes in project scope

Business Development
• Continue to build a network of industry colleagues through relationships formed during project engagements or through other industry experience
• Communicates potential new business leads to PC management and account managers
• May participate in project scoping calls and/or proposal preparation with the support of senior colleagues

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 as requested by management
• Defines self-development activities in order to keep current within the industry (i.e. maintain membership in a relevant industry and/or scientific/technical association)

Candidate Profile
• 5+yrs of experience in an industry-related environment
• Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline
• Project management knowledge
• Client-focused approach to work
• Results orientation
• Teamwork and collaboration 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
Location : India
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory
End Date : 30th April 2024