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
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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
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Global Impact
We are one truly global team working together to propel each client´s journey ahead faster.
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Balance
We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
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Collaboration
Work with industry leaders and subject matter experts.
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Freedom
The ability to innovate, ask “what if” and try new solutions without fear of failure.
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Variety
Opportunities to work on multiple accounts – never boring!
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Management
Strong management with depth of experience working for global health authorities.
Responsibilities
Job Description:
- 8-9 yrs experience in handling of pre and post approval life cycle management of Biologic products in various markets Regulated (EU/US/Canada) and Emerging Markets.
- Good understanding of regulatory framework, including regional trends, for various types of applications and procedures.
- Experience of support the compiling, submission, and approval of country-specific submission files (MAA, LCM, and post-approval changes). 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.
- Support affiliates in updating local requirements based on guidance from regulatory agencies and input from affiliates/distributors.
- Strong understanding of local and international regulatory guidelines.
- Preparation and review of Marketing Authorization Applications & Variations for various types of medicinal products for filing in Regulated, Emerging and EU.
- 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.
- Working experience in Regulatory Information Management Systems like Veeva Vault.
- Strong communications skills. Ability to work independently.
- Effective communication and collaboration skills.
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