Great opportunity to work as Senior Regulatory Affairs Associate at PAREXEL-Apply before 30th April 2024

  • Full Time
  • India

Website Parexel


PAREXEL is a prominent global biopharmaceutical service provider that plays a crucial role in supporting the Bio-Tech and Pharmaceutical industries. They contribute to the development of new drugs and treatments on a global scale. PAREXEL offers knowledge-based services, including contract research, medical communications, and consulting across various therapeutic areas. Their clients span 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.
  • Operates within broad project guidelines as directed by the project lead and/or technical Subject Matter Experts (SMEs).
  • Takes initiative to prioritize work to achieve specified project outcomes while confirming alignment with the project lead and line manager.
  • Seizes opportunities to enhance personal performance and seeks feedback from the project lead and colleagues.
  • Utilizes information provided by the project lead or senior colleagues to complete assigned project activities.
  • Produces high-quality work that meets the expectations of the 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 setup, routinely interacts with the assigned Project Specialist (PS) or Project Manager (PM) to appropriately control the project (e.g., project setup, forecasting and financial entries, invoicing, etc.).
  • Acts as the main client contact and ensures accurate project reporting is in place.
  • Ensures that the project team delivers to meet the client’s expectations for quality and timeliness.
  • Establishes appropriate risk identification and issue-escalation procedures.
  • Ensures project team’s compliance with project-specific training.
  • Manages project financials, including providing accurate revenue forecasts.
  • Ensures the project team understands and works 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:

  • Continues to build a network of industry colleagues through relationships formed during project engagements or through other industry experiences.
  • 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 the 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 to stay current within the industry (i.e., maintain membership in a relevant industry and/or scientific/technical association).

Candidate Profile:

  • 5+ years 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 the 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.
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