Director of Regulatory Affairs

KVK Tech is looking for a Director of Regulatory Affairs to join our team in Newtown, PA.

This position’s responsibilities will include, but not be limited to the following:

Director of Regulatory Affairs (Newtown, PA) – Manage and direct regulatory affairs and compliance and serve as principal regulatory contact with the U.S. Food and Drug Administration (FDA) on matters including Abbreviated New Drug Applications (ANDA) and New Drug Applications (NDA) filings; Lead Global regulatory activities for pharmaceutical projects by applying expertise in Chemistry, Manufacturing, and Controls (CMC) and U.S. pharmacopoeia; Ensure timely regulatory submissions (eCTD) of new drug products to regulatory agencies in USA and Canada (ANDS/NDS); Review and submit Drug Master Files (DMF) and ANDA/NDA amendments, supplements, and annual reports; Oversees regulatory submissions and deficiency responses for target product approvals and new product launches; Provide regulatory strategic, tactical, and operational direction and scientific guidance in chemistry and pharmaceutical chemistry for pharmaceutical products pipeline and key regulatory milestones; Evaluate FDA regulations, directives, guidelines, and policies for potential impact on pharmaceutical product development; Provides regulatory feedback and decisions in early product development discussions as well as submission kick-off meetings; Ensure facility registrations, timely fee payments and DMF acceptance or work with API supplier for adequate DMF deficiency responses to support the drug product approvals; Develop regulatory strategies with coordination of global project management team to drive corporate as well as departmental objectives; Keep up-to-date on regulatory changes, including new regulatory agency guidance and revisions, changes to pharmacopoeia, and related impact to projects and timelines; Recommends and implements regulatory policies, procedures, and best practices; Follow 21CFR, FDA guidelines and ICH guidelines; Manage, guide on site regulatory team and serve as a head of Regulatory department; Supervise 3 staff.

Must have a Master’s Degree in Regulatory Science, Pharmaceutical Science, or Pharmaceutical Chemistry plus 1 year experience in job offered or as Associate Director of Regulatory Affairs. Require skills and knowledge of ANDA/NDA, ANDS/NDS, Regulatory Strategies, Project Management, CMC.

Job location: Newtown, PA. Submit résumé referencing job code RAG007 to HR, KVK-Tech, Inc., 110 Terry Drive, Newtown, PA 18940.

Benefits Include:

401(k) with matching

Health, Vision, Dental Insurance

Childcare Scholarship

Tuition Reimbursement

Bonus Pay Merit Increases

Paid Time Off

Flexible Holidays

KVK Tech is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation or any other protected status.

We encourage you to apply if you feel that you are a match! We look forward to hearing from you.