Sr. Regulatory Affairs Manager
Paramus, NJ 07652
Responsible for the regulatory operations for project development activities and assistance of project management for global clinical studies
Plan, implement, manage and report regulatory activities and submission timelines for global clinical studies.
Full functional knowledge of US regulatory requirements pertaining to the development and registration of biological or oligonucleotide-based products
Experience with IND and NDA filings is required
Working and/or in-depth knowledge of regulatory affairs
Must be able to work effectively in a multi-cultural, global team environment as responsibilities include intensive drug development collaboration with global project teams, external partners and vendors.
Manage review, formatting and ensure regulatory documents to be submission ready to regulatory agencies including FDA and HC.
Manage archive of IND (and CTA) publication and regulatory documents submitted to regulatory agencies including FDA and HC.
Provide regulatory guidance to ensure IND, NDA and any application related communications with regulatory agencies including FDA and HC.
Assist Program Manager of a development project to plan, implement, manage and report project management activities for global clinical studies.
Help to manage project development timeline and cost and ensure that
Project activities are delivered on time and on budget.
Organize and facilitate meetings internally and with outside parties.
Research on regulatory and competitive information, including FDA guideline and announcements, press releases and scientific conferences and publications, etc.
Perform other task and function as required or needed.
Bachelor s degree is preferred with a Master s degree or higher (PhD, PharmD).
Minimum of 5 years of regulatory experience in the biotech/pharmaceutical industry; experience in the hematological malignancies, neuromuscular or orphan diseases is a plus.
Practical experience with biologics, oligonucleotides and small molecules, as well as experience dealing with multiple aspects of regulatory affairs (CMC, clinical, nonclinical) is strongly preferred.
- Strong computer skills, and proficient in MS applications (Word, Excel, PowerPoint)
Ability to handle multiple tasks and prioritize
Strong organizational, communication and presentation skills
- Team player, flexible, ability to adapt to change