Senior Regulatory Affairs Associate (GMP/PAC)

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Key Accountabilities:

Act as primary RA representative for local Commercial and medical team: adopt a business perspective, explore opportunities and translate this thinking into actionable plans that fit with strategy.

Assess and mitigate impact of changes with local team

Project Execution

• Responsible for product and GMP registration dossier preparation and submission of assigned projects.
• Responsible for timely ordering of registration sample, dossier, certificates etc.
• Contribute to the discussion of registration plan with both local and global team.
• Track the registration status in TFDA and timely report to the line manager.
• Address technical questions from TFDA.
• Communicate with global/ regional teams on issues related to product registration, TFDA lab product testing
• Review of promotional materials and labeling.
• Monitor regulation changes and report in timely manner.
• Ensure regulatory activities comply with internal Code of Conduct and SOPs
• Regulatory support to cross functions and department
• Responsible for product and GMP registration dossier preparation and submission of assigned projects.
• Responsible for timely ordering of registration sample, dossier, certificates etc.
• Contribute to the discussion of registration plan with both local and global team.
• Track the registration status in TFDA and timely report to the line manager.
• Address technical questions from TFDA.
• Communicate with global/ regional teams on issues related to product registration, TFDA lab product testing
• Review of promotional materials and labeling.
• Monitor regulation changes and report in timely manner.
• Ensure regulatory activities comply with internal Code of Conduct and SOPs
• Regulatory support to cross functions and department

• 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, and would be 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)

Skills:

• 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

Knowledge and Experience:

• Few years of experience in an industry-related environment

Education:

• Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline