CEL - ASSOCIATE DIRECTOR
Job Number: 21-07010
Job Number: 21-07010
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for an Associate Director for our client in Summit, 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!
- Develop and implement global regulatory strategy for assigned projects, along with Regional Regulatory Affairs representatives and Regulatory CMC.
- Lead global and/or regional regulatory team on assigned projects.
- Develop and execute US regulatory strategy and contingencies for assigned projects.
- Serve as the primary interface for FDA on assigned projects.
- Lead the preparation of submissions, which may include INDs Briefing Documents, Orphan Drug Applications, and Marketing Applications etc. Work with functional groups to define contributions to submissions. Lead regulatory submission teams for projects assigned.
- Prepare company team for FDA and other health agency meetings, as required.
- Serve as the primary interface with Regulatory CROs for coordination and preparation of submissions.
- Represent Regulatory Affairs on various cross-functional teams, including Project Teams, Clinical Teams and Study Teams.
- Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidances.
- Contribute to the development and maintenance of Regulatory Affairs working practices and procedures.
- Bachelor's degree in scientific discipline; advanced scientific degree preferred.
- Experience in multiple phases of development in various therapeutic areas. Experience in inflammatory and immune diseases a plus.
- 5-9 years pharmaceutical industry experience, including 3-5 years in regulatory affairs. Global experience desired.
- Thorough knowledge of the drug development process, IND and NDA process.
- Demonstrated experience in preparing FDA submissions.
- Inter-dependant partnering skills, team-oriented and ability to influence outcomes are necessary skills in the environment.
- Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.
- Must be able to innovate, analyze and solve critical problems with minimal supervision and attention to detail.
- Domestic and occasional International travel may be necessary.
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:
John Bayog | LinkedIn
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.