Vice President of Regulatory Affairs

Permanent

Full Time

Develop and execute regulatory strategy for the development of company programs, aligned with departmental objectives, timeframes and company goals.

Duties and Responsibilities

Develop and execute regulatory strategy for the development of company programs, aligned with departmental objectives, timeframes and company goals.
Collaborates with Research and Development, Quality, Commercial and Medical Affairs to implement highly effective regulatory strategies that complement business development goals.
Conducts and creates strategies for FDA device and drug submissions, FDA scientific advice meetings, as well as develop plans for IND amendments and NDA supplements.
Oversees creation of documentation to support IND, NDA and Orphan drug filings.
Liaises with regulatory authorities as needed for all aspects pertaining to drug and device development approval.
Leads preparation for the conduct of meetings with regulatory agencies and coordinates IND/NDA/PADER and Annual reports, as required.
Maintains awareness of global regulatory legislation and assesses impact to overall business and product development programs.
Provides guidance to internal groups and business partners based on technical and regulatory knowledge towards development of strategic and tactical plans.
Maintains compliance with the Company’s procedures, policies and regulatory commitments.
Other duties as assigned by management

Advanced Scientific Degree required, i.e., MS, PharmD, PhD, MD.
Professional certification is preferred. (e.g. RAC)
Minimum of 10 years of US Regulatory Affairs experience, including post marketing activities, with primary focus in prescription drugs and medical device.
Demonstrated expertise in US regulatory requirements; ability to interpret and apply regulations (FDA, ICH, and other) to specific projects.
Demonstrated knowledge and understanding of clinical development/drug development process.
Aptitude in cGMP manufacturing and Quality/Compliance requirements.
Supervisory experience required.

Competencies:

Problem Solving–Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations.
Technical Skills–Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
Teamwork–Balances team and individual responsibilities; Exhibits objectivity and openness to others’ views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone’s efforts to succeed.
Quality Management–Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
Quantity–Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.

Supervisory Responsibilities:

Manages regulatory staff, both internal and consultants and verifies job related training as assigned within the required timelines.