Regulatory Affairs Associate

2 weeks ago

Bengaluru, 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.

1. 2-4 yrs of experience in a regulatory environment with preference given to drug/device/biologic-related industry, and experience with electronic publishing of regulatory submissions.

2.Compilation, publishing, and technical quality control of Regulatory submissions

(Nees, paper and eCTD format) including technical troubleshooting to ensure issues within submissions are resolved and deadlines met.
3. Creation of cross-references, table of content, tab / slip-sheets, and volumes for Paper submissions.
4. Performing bookmarking, hyper-linking, and tables of content creation according to Health Authority (HA) guidelines for Electronic Submissions.

5. Knowledge of medical/scientific terminology, ICH guidelines and regulations and procedures preferred. Knowledge of submission requirements of various markets such as USFDA, EMA etc. is preferable.

6.Good communication, organizational, and interpersonal skills.

7. Knowledge of submission dispatches to Health Authorities is preferrable.

8. Word formatting using plug-ins such as starting point template/other template experience is preferable.

**Qualification**

B.Pharm
- Regulatory Affairs/M. Pharm
- Regulatory Affairs

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