Global Regulatory Manager
Global Regulatory Manager
Job Number: 21-10811
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Global Regulatory Manager for our client in Lawrenceville, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- Responsible for driving regulatory processes in line with business/R&D objectives to ensure timely registration of new products/line extensions and variation applications of Client products.
- Responsible for interactions with Country Regulatory managers/regional leads regarding product registrations.
- Drives and support local projects and department related assignments.
- Responsible to keep up to date with the regulatory environment within the industry.
- Responsible for archiving of regulatory files and documentation, and maintenance of regulatory databases and manage all updates in our RIM Veeva vault system
- Act as a key partner with the country Business function, Medical function, Clinical Operations function, Market Access function and Logistics function.
- Responsible for overall regulatory related topics for assigned products /therapeutic area.
- Coordinate internal alignment and approval of global submission plans; ensure those plans can be executed with internal and external resources on time
- Manage, track, review regulatory deliverables from external partners in line with vendor manager
- Doctor of Pharmacy or equivalent
- 2-4 years of relevant experience expected, especially in Intercontinental region
- Demonstrated ability to break down complex, scientific content into logical components.
- Ability to write in a clear, concise, and persuasive manner
- Strong project management skills
- Highly proficient in the use of Microsoft Word and PowerPoint
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.