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
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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
- Around 7-10 years of relevant experience in handling life cycle management of approved drug products (small molecules as well as biologicals including Vaccines, monoclonal antibodies) in various markets.
- Good understanding of regulatory framework, including regional trends, for various types of applications and procedures.
- Lead and / or contribute to the planning, preparation, authoring and delivery of regulatory maintenance submissions from either a global and/or regional perspective.
- Responsible for managing (Authoring and Review) of biosimilar investigational product submission such as IND & IMPD for USFDA, EMA
- Authoring, review, and submission of BLA/MAA of biosimilar dossiers for US/EU/ROW /India markets.
- Preparation / Review of Regulatory gap analysis and strategy documents (with remediation plans for identified gaps) for submissions like IND, IMPD, DMF, BLA, NDA, and MAA applications.
- Life cycle management (LCM) for approved products. (Annual reports, variations, renewals) for Europe (Type IA/IB/II/IAIN) / US and other ROW markets.
- Evaluation of change controls and deviations and defining regulatory strategy .
- Co-ordination with internal and external stake holders for documentation required for filing. Identify quality and/or timeliness issues with source documents, as early as possible
- Develop up-to-date knowledge about regulatory guideline updates and applies regulatory requirements and their impact on submissions.
- 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.
- Review and submit safety variations to Health Authorities and perform post Approval CMC / labeling related updates.
- Authoring content of the label (EU, Canada, AU/NZ & US) based on Company Core Data Sheet (CCDS) / PRAC / CMDH recommendations.
- Familiarity with EU Guidelines for QRD / Excipients.
- Artwork management for countries with label in English.
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