Previous Job
Previous
Direct Hire - Associate Director, Global Regulatory Affairs - Oncology
Ref No.: 18-26490
Location: Woodcliff Lake, New Jersey
Position Type:Direct Placement
Start Date / End Date: 05/28/2018 to 08/27/2018
Job Title: Associate Director, Global Regulatory Affairs - Oncology
Work Location: Woodcliff Lake, NJ
Type of Position: Permanent- Full Time
Client: A Big Pharmaceutical Company

Job Description

The Associate Director, Regulatory Affairs will be responsible for providing all aspects of regulatory support for supplemental indications associated with an approved Oncology agent. In addition, this position will serve as the lead support for early phase Oncology compounds. This person may participate in departmental work streams designed to improve development cycle timelines or to improve regulatory processes.

Responsibilities include but are not limited to:
1. Regulatory Submissions (IND/NDA): Monitoring regulatory submission activities and reviewing regulatory documents prior to submission to ensure overall quality, compliance and timeliness. Partnering with project teams to assess regulatory support needs and aligns resources (i.e., sub teams) to provide regulatory support
2. Interfacing with Authorities: Acting as the point of contact with regulatory authorities for assigned product(s). Leads calls or meetings with regulatory authorities.
3. Regulatory Strategy Development: Contributing to the development of global regulatory strategies across programs for own functional area and region. Identifies, monitors and resolves regulatory issues and reports progress to management
4.Compliance: Ensuring compliance with all applicable laws / regulations of each country in which we do business. Demonstrates high ethical behavior at all times, whether dealing with colleagues, vendors, patients, or physicians. Reports legal, compliance and ethical violations in a timely manner
5. Life Cycle Management: Leading the planning, execution and assessment of product life cycle management activities and strategies

Job Qualifications:
• BS/BA in Life Sciences in a relevant field with 10+ years of broad pharmaceutical experience, including 6+ years of new drug regulated product strategy/submissions or a Master's Degree with 8+ years of related Regulatory experience, including fellowship experience or a PharmD or PhD with 5+ years of related Regulatory experience, including fellowship experience.
• Experience interacting with the FDA and ex-US health authorities
• Development and preparation of successful regulatory strategies and the ability to contribute to the development and writing of a regulatory strategy document
• Experience developing global regulatory strategies in coordination with clinical plans and marketing objectives
• Experience in successfully leading teams and the ability to broadly represent GRA functions on project teams
• Demonstrated matrix leadership skills and the ability to work effectively in a matrix team across multiple disciplines
• Working knowledge of relevant drug laws, regulations and guidance's/guidelines.

Interested candidates can share their most updated resume at wajid.khan@artechinfo.com or they can reach out to me on #973-967-3412.