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KVK TECH is Hiring a Regulatory Associate Near Newtown, PA
Job Description
Department: Regulatory Affairs
Job Title: Regulatory Associate
1. Role Purpose:
Primary responsibility is writing regulatory submissions by successfully coordinating with the Manager for priorities; while maintaining compliance with cGMP requirements, FDA, OSHA, EPA, and DEA.
2. Key Duties & Responsibilities:
- Interacts effectively with cross functional teams to coordinate/facilitate procurement of documentation required for regulatory submissions, ensuring that departmental timelines are met.
- Create documents in accordance with eCTD specifications.
- Prepare and submit regulatory submissions using eCTD software, publishing tool to FDA.
- Author, compile and review technical documents (CMC) for accuracy and acceptability in New Applications (i.e. ANDAs or NDAs], Amendments, Supplements, PADER, Annual Reports and other required FDA filings to ensure high-quality submissions and expeditious approvals from FDA.
- Coordinate preparation of SPL for drug products and update labelling, annual drug listing.
- Reviews and signs-off on change control documentation. Assesses changes and their impact on the business based on an understanding of product, regulatory guidelines and applicable federal laws.
- Update and maintain the internal database as needed.
- Comply with FDA guidelines/Company Policies of Data Integrity.
- Effectively prioritizes competing tasks in a fast-paced and dynamic environment.
- Other duties as required or delegated
3. Typical Supervisory Responsibility:
N/A
4. Education & Experience:
Education Requirement
Specialization (If any)
Bachelor’s Degree in Pharmacy, Chemistry or Scientific Discipline preferred
Experience Requirement
N/A
Number of Years
N/A
5. Technical competencies/ Certifications/ Licenses:
Technical competencies
- At least 1 year experience with technical writing preferred
- Minimum 3 years Pharma experience preferred
- Proficient with Adobe PDF, Illustrator/In Design, Microsoft Office and advanced computer skills
- Continuous working knowledge of applicable FDA/ICH/DEA regulations
- Continuous working knowledge of applicable cGMP guidelines
Certifications
N/A
Licenses
N/A
Other
N/A
6. Physical demand and Work environment:
a. 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.
b. Work environment:
N/A
Job Summary
Full Time
$83k-109k (estimate)
06/22/2024
07/11/2024
kvktech.com
NEWTOWN, PA
200 - 500
2004
ANTHONY TABASSO
$50M - $200M
Pharmaceutical
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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.
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The following is the career advancement route for Regulatory Associate positions, which can be used as a reference in future career path planning. As a Regulatory Associate, it can be promoted into senior positions as a Top Regulatory Affairs Executive that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Associate. You can explore the career advancement for a Regulatory Associate below and select your interested title to get hiring information.
