VP, Regulatory Affairs and Quality Assurance
Employment Type: Regular
Reference Number: R109
The VP will lead, create, and drive the regulatory strategy for clinical development programs and ensure that there is a sound regulatory foundation for the successful advancement of the products through development and ultimately well positioned for rapid global regulatory approval. The VP will have primary responsibility for regulatory strategy, regulatory interactions, and submissions, both domestically and globally. The VP will also play a leadership role providing management and guidance across the function. Manage and mentor Regulatory Affairs direct reports as appropriate.
Based on an outsourcing GxP model, the VP is responsible for leadership and direction of all aspects of the Quality Assurance function, to ensure appropriate level of compliance of the company's clinical development activities and clinical trial material production with recognized regulations and guidelines. This individual will design, implement and maintain QA and compliance programs and infrastructure - including an SOP system and training program, appropriate for an outsourced GxP model - and perform internal and external audits. The VP will establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance in a GxP international regulatory environment. Ensure training programs meet GxP and ICH requirements. Provide expertise and guidance to departments in interpreting and implementing governmental and agency guidelines to assure compliance. Manage and mentor Quality Assurance direct reports as appropriate.
Formulate and oversee implementation of regulatory strategy and activities needed to secure product approval.
Manage coordination, preparation and timely submission of regulatory documents (e.g.,INDs, MAAs, NDAs).
Author, review and critique documents that will be included in regulatory applications and interactions.
Maintain expert knowledge of, and familiarity with, FDA/EMA regulations and ICH guidelines.
Provide clear and valid regulatory guidance and direction to other departments and project teams.
Represent regulatory strategy at project team meetings and provide regulatory support for projects which may include clinical, preclinical, CMC and marketing issues.
Develop and maintain relationships with external vendors and health care regulatory authorities.
Manage all activities pertaining to interactions with FDA, and other health care regulatory authorities, and communicate outcomes to senior management.
Supervise team members and consultants to the Regulatory Affairs and Quality Assurance department.
Develop and implement standard operating procedures and common work practices within the team.
Host FDA/third party regulatory audits and ensure follow up on findings/observations issued.
Foster strong relationships and advocacy with FDA and international regulatory authorities as well as ensuring strong coordination and collaboration across internal functional and stakeholders.
Provide guidance to business development regarding critical evaluation of potential opportunities in support of strategic partnering and licensing activities.
What is Required
Minimum BS degree in a scientific discipline, preferably life sciences or pharmacy; regulatory certification (RAC) a plus.
10+ years of progressively responsible experience in drug development, regulatory affairs, and QA oversight in the biotechnology or pharmaceutical industry.
3 years of leadership experience in a regulatory affairs and quality assurance management role.
An advanced degree in the biological sciences (MD, PhD, or PharmD).
Demonstrated knowledge in the regulatory aspects of clinical development, including protocol development, data collection and analysis, preparation of regulatory submissions including Investigational New Drug (IND) and New Drug Applications (NDA), and prosecution of NDAs through review to a final decision by health care regulatory authorities, specifically including FDA and EMA.
Knowledge and management of the regulatory aspects of drug manufacturing, quality assurance, and GCP and GMP compliance is a strong plus.
Demonstrated expert knowledge of the regulations and practices of FDA, EMA, and other major health care regulatory authorities.
Demonstrated experience in negotiating with and presenting to regulatory agencies such as FDA.
Prior experience of NDAs and MAAs and gaining global regulatory approvals is desirable.
Strong consulting and analytical skills and the ability to understand, balance, and articulate both tactical and strategic issues and solutions.
Demonstrated management expertise, including the leadership and professional development of the Regulatory team.
A hands-on leader who leads by example as well as willingness to roll-up sleeves and draft sections for regulatory submissions.
Demonstrated ability to work independently with exceptional organization and attention to detail.
Excellent oral and written communication and presentation skills.
Ability to work well under pressure and adhere to deadlines.
Proficient in the delivery and conduct of all Regulatory Affairs activities including, but not limited to: submissions, publishing, review, and oversight.
Solid and demonstrable knowledge of international GxP regulations and guidelines, industry practices, and experience implementing Quality Systems in a regulated environment
Working knowledge of GxP international regulations.
$295,000 - $465,000
The salary range listed in the job posting reflects the anticipated base pay range for this role in the United States. Actual base pay decisions consider a variety of factors including, but not limited to, an individual’s skills, qualifications, and experience. In addition to a competitive base salary, this role is currently eligible for our annual discretionary bonus program and annual equity awards (roles on a sales-incentive commission plan will not be eligible for our annual discretionary bonus).
Mirati employees (and their families) are provided a competitive benefits package including:
Comprehensive healthcare coverage – multiple medical plan choices with an employer-funded HSA, dental & vision
Company provided life insurance and disability coverage
401(k) retirement plan with a 6% company match and immediate vesting
Employee Stock Purchase Plan with a 15% discount
Extensive time off – holiday / PTO and two, week-long paid breaks in the summer and winter
Mirati is an Equal opportunity Employer (EOE). We celebrate diverse experiences without regard to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.
No matter the role, we are unified by our passion for helping patients and are inspired by a single vision to unlock the science behind the promise of a life beyond cancer. Together we own Mirati’s success.