Job Description :
Team Lead – Regulatory Affairs – Multiple positions
Location: Bridgewater, NJ

Responsibilities:
Develops and mentors associates by providing expertise in all submission types applicable to their region of responsibility.•
Leads team of publishers (Sr. and Jr. Levels), manages people.•
Coordinates and triages all submission work activity.•
Provides input into client processes and software to Engagement Manager for communication back to client.•
Communicates issues and concerns to Delivery Lead proactively.•
QCs work through spot checks on a regular basis.•
Understands client expectations.•
Main point of contact for client LRAs. Communicates issues and concerns to Delivery Lead proactively.•
QCs work through spot chec•ks on a regular basis.
Understands client expectations.•
Main point of contact for client LRAs•

Skills Required:
Regulatory Affairs knowledge•
Different submission procedures (EU• & US)
Good Clinical Practice (GCP)•
21 CFR part 11•
Excellent verbal• & written communication
Ability to prioritize work•
Ability to direct regulatory strategy and contribute to its outcome when necessary.•
Excellent people management skills.•

Qualifications:
Diploma/ Bachelor degree in Pharmacy, Life-Science•
Minimum of 5 - 7 years in Regulatory Operations and Document Publishing•

Performance Standards:
Measurable
Establish systems and procedures in the team.•
Compliance with KPI’s•
Customer satisfaction index•

Non-Measurable
Self-motivation•
Achievement building orientation•
Relationship building ability•
Inclination towards being process driven•
Going out of way to satisfy the external customer•
Punctuality (self-discipline• )