Executive Director of Regulatory Affairs/Quality Assurance (Offering Relocation Assistance) - Tucson, AZ | Biospace
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Executive Director of Regulatory Affairs/Quality Assurance (Offering Relocation Assistance)

Insperity

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Location:
Tucson, AZ
Posted Date:
7/27/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:

Job Description

We are developing therapeutics designed to reduce the risk of cancer, an approach that has been used with great success in other disease categories such as cardiovascular, neurovascular, and infectious disease.



Reporting to the CEO, this role will be the Regulatory Affairs and Quality Assurance leader and be responsible for developing and directing the Company’s regulatory strategy, objectives, policies and programs from IND planning through NDA and commercialization. We will also rely on you to be responsible for implementing, maintaining, and overseeing audit-ready quality systems. As the company grows, you will build and lead a team of regulatory and quality professionals to meet global development and regulatory requirements.

Requirements

Responsibilities:

-Manage strategic regulatory direction and guidance on corporate projects and key strategic business initiatives.
-Provide proactive guidance to internal groups based on technical and regulatory knowledge towards development of strategic and tactical drug development plans.
-Identify and assess regulatory risks associated with product development for all projects.
-Develop strategic plans and tactical implementation leading to the creation and submission of regulatory documents, e.g., INDs, NDAs, CTAs, MAAs, supplemental NDAs, applications for Orphan Drug status, Fast Track, and Breakthrough Therapy designations and other relevant regulatory filings.
-Act as the primary corporate contact with the FDA and other regulatory Health Authority (HA) agencies and effectively leads key meetings with HAs to ensure full discussion of issues and opportunities.
-Be the company expert on current regulations and guidance, interpret and notify appropriate personnel; provide guidance to all appropriate departments to assure compliance with applicable regulations.
-Develop, implement, and maintain quality systems to ensure audit readiness appropriate for each stage of development.
-Create, implement, train, and maintain training for all company personnel on Standard Operating Procedures.
-Manage the project(s) within the approved budgets and timelines.
-Develop detailed plans and prioritize the tasks within the plan to achieve project goals.
-Leverage resources, expertise, and knowledge across multiple projects to ensure attainment of project deliverables.
-Effectively communicate within the project team and with functional management.
-Identify project risks and develop and implement the mitigations for these risks.
-Participate on product development and business teams to provide regulatory and quality assurance functional area expertise.
-Partner with functional peers to manage, adjust, and revise project timelines and budgets as necessary.
-Communicate project status and issues to management and other team members and ensure that project team goals are met.
-Determine activities that are critical to company success and priorities within functional area.
-Anticipate obstacles of varying complexity and implement solutions to achieve project goals; may lead strategic initiatives.
-Participate in executive committee(s) to ensure regulatory operations are consistent with overall corporate and business objectives of the company.


Qualifications:        

Education and Experience:

-An advanced life science degree (MS, Ph.D., M.D.) in the life sciences with 10+ years of Regulatory Affairs experience in Pharmaceutical or Biotechnology companies required.
-Expert knowledge of the drug development process and FDA regulatory requirements; ex-US experience desirable.
-Knowledge of domestic and international regulations and guidelines regarding drug development, regulatory submissions and corresponding regulatory agency interactions.
-Experience with successful registration of drugs in the US. Ex-US experience highly desirable.
-Experience with preparation and conduct of FDA advisory committee meetings preferred.


Additional Skills and Abilities:

-Working knowledge of Microsoft Office, specifically MS Word and PowerPoint, MS Excel, as well as Internet software.
-Knowledge in the area of study (Cancer Prevention, Oncology).
-Effective work planning and organizational skills including budgeting for material requirements. -Strong strategic and analytical abilities, diplomacy, and negotiation skills.
-Effective interpersonal skills; balances team and individual responsibilities, exhibits objectivity and openness to others’ views; gives and welcomes feedback; contributes to building a positive team spirit; able to build morale and group commitments to goals and objectives; supports everyone’s efforts to succeed.
Demonstrated ability to perform detail oriented work with a high degree of accuracy.
Effective written and verbal communication skills. Writes clearly and informatively, edits work for spelling and grammar, varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information. Verbal communication, speaks clearly and persuasively in positive or negative situations, listens and gets clarification; responds well to questions; demonstrates group presentation skills, participates in meetings.
Project management, assists with project plans, coordinates projects; communicates changes and progress; completes projects on time and budget.
Effective training skills.
Effective leadership skills.
Able to work independently and with minimal supervision.
Able to prioritize and plan work activities, use time efficiently; plan for additional resources, set goals and objectives.
Professionalism, reacts well under pressure, approaches other in a tactful manner; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments.