Junior Regulatory Affairs Associate

6 days ago

Remote, India Parexel Full time

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.

In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.
- Full Time
- Travel: Yes
- Glassdoor Reviews and Company Rating

**Success Profile**:
Check out the top traits we're looking for and see if you have the right mix.
- Detail-Oriented
- Proactive
- Problem-Solver
- Results-Driven
- Organized
- Multi-Tasker

**Rewards**:

- **Global Impact**: We are one truly global team working together to propel each client´s journey ahead faster.
- **Balance**: We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
- **Freedom**: The ability to innovate, ask “what if” and try new solutions without fear of failure.
- **Variety**: Opportunities to work on multiple accounts - never boring
- **Management**: Strong management with depth of experience working for global health authorities.

**Key Accountabilities**:
**Project Administration**:

- Under supervision provide basic paper and electronic publishing services including document preparation, legacy conversion, scanning, rendering, bookmarking, hyperlinking, compilation, table of contents creation, volumization, pagination, and formatting of reports and simple submissions.
- Provide basic regulatory affairs services including preparing submission packages Capitalizes on opportunities to improve project efficiency, results or team performance and proactively takes action

**Document Management**:

- Under supervision perform basic document management tasks including file transfer, storage, tracking, and archival of Regulatory Guidelines
- Develop a familiarity with current global regulatory submission standards.

**Standard Operating Procedures**:

- Develop a familiarity with departmental standard operating procedures and work instructions.

**Product Support**:

- (Regulatory Affairs only) Under supervision provide support to currently marketed products.

**Skills**:
**Project Execution**:

- Works effectively within a team environment.
- Works within broad project guidelines as directed by the project Technical Lead or Project Manager.
- With the guidance of the project Technical Lead or Project Manager, demonstrates the ability to prioritize work to achieve specified project outcomes.
- Capitalizes on opportunities to improve performance and seeks feedback from the project Team Lead and colleagues.
- Applies information provided by the project Team Lead or senior colleagues to complete assigned project activities.
- Produces quality work that meets the expectations of Project Lead and the client.

**Relationship Management**:

- Completes assigned activities within project scope and objectives under the direction of the Project Lead
- Identifies project and internal issues to senior colleagues and Project Lead
- Interacts professionally at all working levels within a client organization and within PAREXEL
- Identifies project and/or client needs to the Project Lead

**Parexel-Related Responsibilities**:

- Meets established metrics as specified in scorecard on an annual basis
- Completes basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, project deliverable archiving, participation in internal initiatives/projects or as a mentor as requested by management
- Defines self-development activities with the support of management to keep current within the industry

**Knowledge and Experience**:

- 0-2 years’ experience in an industry-related environment

**Education**:

- Bachelor’s Degree in a Scientific or Technical Discipline.

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