Recent Searches

You haven't searched anything yet.

2 Regulatory Group Leader Jobs in Newtown, PA

SET JOB ALERT
Details...
KVK TECH
Newtown, PA | Full Time
$77k-101k (estimate)
Just Posted
KVK TECH
Newtown, PA | Full Time
$80k-105k (estimate)
3 Weeks Ago
Regulatory Group Leader
KVK TECH Newtown, PA
$80k-105k (estimate)
Full Time | Pharmaceutical 3 Weeks Ago
Save

KVK TECH is Hiring a Regulatory Group Leader Near Newtown, PA

Job DescriptionDepartmentRegulatory Affairs
Job TitleGroup Leader
FLSA StatusExempt
Reports ToDirect of Regulatory Affairs
  • Role Purpose:
Primary responsibilities are to manage, prepare and submit regulatory submissions by successfully coordinating with the Manager for priorities; while maintaining compliance with cGMP requirements, FDA, OSHA, EPA, and DEA.
  • Key Duties & Responsibilities:
  • Trains Regulatory Associates
  • Collaborates with R&D, QC and Production Managers
  • Handles all aspects of regulatory submissions (i.e. ANDA and NDA)
  • Assists associates, coordinators, analysts, auditors and specialists as needed
  • Handles and completes special projects as required
  • Comply with FDA guidelines/Company Policies of Data Integrity
  • Other duties as required or delegated
  • Typical Supervisory Responsibility:
Serves as an effective member of the Regulatory Affairs team and may serve as a mentor to other regulatory employees in the area of expertise.
  • Education & Experience:
Education RequirementSpecialization (If any)Bachelor’s Degree in Pharmacy, Chemistry or Scientific Discipline preferred
Experience Requirement
  • Technical competencies/ Certifications/ Licenses:
Technical competencies
  • At least 2 - 3 years’ experience with technical writing preferred
  • Minimum 5 years Pharma experience preferred
  • Strong communication and problem-solving skills
  • Proficient with Adobe PDF, Microsoft Office, XML, eCTD tools and advanced computer skills
  • Continuous working knowledge of applicable FDA/ICH/DEA regulations
  • Continuous working knowledge of applicable cGMP guidelines
  • Physical demand and Work environment:
  • Physical demands:
While performing the duties of this job, the employee is required to walk, sit, and use hands to finger, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception.
  • Work environment:
N/A

Job Summary

JOB TYPE

Full Time

INDUSTRY

Pharmaceutical

SALARY

$80k-105k (estimate)

POST DATE

05/31/2024

EXPIRATION DATE

08/24/2024

WEBSITE

kvktech.com

HEADQUARTERS

NEWTOWN, PA

SIZE

200 - 500

FOUNDED

2004

CEO

ANTHONY TABASSO

REVENUE

$50M - $200M

INDUSTRY

Pharmaceutical

Related Companies
About KVK TECH

KVK is a leader in the development and manufacture of high-quality, FDA-approved medicines that address unmet patient needs. We take pride in our ability to advance medical care and offer low-cost alternatives in response to todays healthcare challenges. All of our products are manufactured, packaged and distributed by KVK in the United States. VISION: By 2020, KVK will apply its relentless drive to manufacture high-quality, affordable generics in every major dosage form, states Anthony Tabasso, CEO and President of KVK Tech. And, all of our products will be made in the USA, right here in Penn...sylvania. KVK is committed to expansion through alliances across all phases of operations, which is evidenced by the current construction of a 250,000-square-foot sterile injectable plant in nearby Langhorne and the purchase of the 461,000-square-foot Lockheed-Martin complex in Newtown. We continue to explore strategic opportunities to add to our expanding portfolio and are aggressively pursuing research and development prospects, including investment in new molecular entities. And, we continue with developments in oral solids, such as extended or slow release tablets or capsules, all the while maintaining high manufacturing standards and exemplary customer service. MISSION: To continually build on our promise to deliver safe, effective and affordable FDA-approved pharmaceuticals to meet our customers needs and ensure that patients have access to high-quality medicines when they need it. Our confidence in our ability to execute and play a key role in the pharmaceutical marketplace is underscored by the dedication of our employees and their commitment to excellence in science, manufacturing, quality control, regulatory compliance and customer satisfaction. More
Show less

Show more
Show more

KVK TECH
Full Time
$43k-55k (estimate)
1 Day Ago
KVK TECH
Full Time
$66k-81k (estimate)
3 Weeks Ago
KVK TECH
Full Time
$51k-64k (estimate)
3 Weeks Ago