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
- 8+ years’ experience in handling life cycle management of approved drug products (like-Tablets, Syrups, Ointments, Nasal Sprays) for ROW markets.
- Working knowledge of ROW regulatory guidelines, including post approval requirements.
- Knowledge of ASEAN markets’ regulatory legislations would be an added advantage.
- Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of simple and more complex regulatory maintenance submissions from either a global and/or regional perspective.
- Lead/Plan, prepare, review and strategize minor labelling variations & safety labelling variations across the ROW countries as per business requirements.
- Experience in handling CMC & labelling related health authority queries.
- Liaise closely with cross-functional members with aligned responsibilities and proactively provide status updates to designated stakeholders.
- Prior working experience in Regulatory Information Management Systems like Veeva Vault would be desirable.
- Experience on Artwork Management Tools like Vista link would be an added advantage.
- Strong listening and communication skills would be desirable.
- Ability to work independently without the need to supervise.
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