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
- Level: Mid
- 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.
-
Collaboration
Work with industry leaders and subject matter experts.
-
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.
Responsibilities
Senior Regulatory Affairs Associate
- Around 4-8 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets.
- Good understanding of regulatory framework, including regional trends, for various types of applications and procedures
- Contribute to preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.
- Working knowledge of EU/US regulatory procedures including post approval requirements. Knowledge of ROW markets regulatory legislations would be an added advantage
- Experience in handling CMC related health authority queries
- Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries.
- Preparation and review of Marketing Authorization Applications & Variations for various types of medicinal products (Orals & Parenterals) for filing in EU through different types of procedures (DCP/MRP/National Procedures).
- Preparation of documentation for different types of Variation procedures like Super grouping,
- Grouping and Work-sharing to the Marketing Authorizations.
- Regulatory review of DMFs, batch records, specifications, and stability data to ensure their compliance with the regulatory requirements.
- Providing regulatory impact assessment for change proposals and identification of required documentation for EU submissions
- Liaise closely with cross-functional members with aligned product responsibilities.
- Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
- To prepare, review and submit safety variations to Health Authorities and perform post Approval CMC related updates.
- Working experience in Regulatory Information Management Systems like Veeva Vault.
- Strong communications skills and ability to guide and mentor team members.
Ability to work independently.
Recently Viewed Jobs
You have not recently viewed any jobs
View all jobs