Regulatory Strategy, Vice President (Bay Area, Boston)
Premier Research is looking for a Regulatory Strategy, Vice President (Bay Area, Boston) to join our Regulatory Affairs team.
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
Your ideas influence the way we work, and your voice matters here.
As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
What You'll Be Doing:
Supervises, mentors, and motivates reporting associates in tasks and activities in order to develop and maintain the team structure; conducts performance reviews; participates in hiring new staff as needed.
Develops and implements strategic plans and objectives for Premier in alignment with corporate strategy and revenue targets in the delivery of high-quality regulatory services within specific geographies, regulatory pathways, or therapeutic areas.
Participates in the development of corporate methods, techniques and evaluation criteria for projects, programs, and people including but not limited to development of client budgets; oversight of staff (where applicable) to ensure the achievement of productivity targets; ensuring accurate and timely completion of employee timekeeping; review and approval of client invoices.
Consults and advises from an expert level knowledge of laws, regulations, and guidelines on the conduct of clinical trials in the US, Europe, and other countries, and maintains an expert advisory level knowledge of regulations regarding the preclinical, chemistry, manufacturing and controls, and clinical development requirements for both clinical trial and marketing authorization of new drugs.
Develop and maintain an excellent working relationship with the FDA, EMA and other regulators and key government regulatory agencies to execute international and regional strategies for assigned projects including both 505(b)(1) and 505(b)(2) applications in the US, or their global equivalents internationally
Provides leadership in the preparation of regulatory strategies, review of clinical development plans, production of regulatory submission materials, and interactions with health authority for clients.
Provides strategic and tactical guidance to clients, Premier senior management, and project teams to drive backlog and revenue growth across all consulting services while supporting timely and efficient clinical development programs and maintaining full compliance with all regulatory requirements.
Partners with Business Development to cross-sell Premier’s clinical CRO services and supports Marketing-led campaign development and execution with content development expertise.
Presents at applicable industry engagements to project Premier’s expertise in the market and partners with Marketing in the development of resources such as blogs, data sets, etc.
Performs additional duties and assignments as requested from time to time.
What We Are Searching For:
Minimum BS or MS degree in a science-related field. A PharmD or PhD degree is preferred.
Minimum of fifteen years regulatory experience in the pharmaceutical, CRO, biotechnology or consulting industry, involving regulatory submissions in drug development, at least seven years of which should be in a management position in a regulatory affairs department.
Minimum ten years of experience managing a team.
Experience in the preparation of regulatory submissions in the US and/or Europe is required.
Experience with supervisory and financial management responsibilities in a regulatory affairs department of a CRO, pharmaceutical/biotech or consulting firm).
Experience working in multidisciplinary project teams.
Demonstrated skills in complex reasoning, risk management, risk benefit and cost benefit assessments
Demonstrated in-depth knowledge of applicable laws, regulations and guidelines covering the conduct of clinical trials and the submission of regulatory applications in the ICH territories, and a solid working knowledge of regulations regarding the pre-clinical, chemistry, manufacturing and controls, and clinical development in the US and the rest of the world
Demonstrated track record of successful FDA IND applications and product approvals (or the applicable international equivalents).
Excellent written/verbal communication, presentation skills, and an ability to persuade and influence.
Excellent interpersonal, motivational and team building skills
Demonstrated scientific acumen in designated functional/therapeutic domain
Preferred Location: San Francisco or Boston
Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized minimum base pay for this role is $200,000.00 USD. The actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.
Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
Your ideas influence the way we work, and your voice matters here.
As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
What You'll Be Doing:
Supervises, mentors, and motivates reporting associates in tasks and activities in order to develop and maintain the team structure; conducts performance reviews; participates in hiring new staff as needed.
Develops and implements strategic plans and objectives for Premier in alignment with corporate strategy and revenue targets in the delivery of high-quality regulatory services within specific geographies, regulatory pathways, or therapeutic areas.
Participates in the development of corporate methods, techniques and evaluation criteria for projects, programs, and people including but not limited to development of client budgets; oversight of staff (where applicable) to ensure the achievement of productivity targets; ensuring accurate and timely completion of employee timekeeping; review and approval of client invoices.
Consults and advises from an expert level knowledge of laws, regulations, and guidelines on the conduct of clinical trials in the US, Europe, and other countries, and maintains an expert advisory level knowledge of regulations regarding the preclinical, chemistry, manufacturing and controls, and clinical development requirements for both clinical trial and marketing authorization of new drugs.
Develop and maintain an excellent working relationship with the FDA, EMA and other regulators and key government regulatory agencies to execute international and regional strategies for assigned projects including both 505(b)(1) and 505(b)(2) applications in the US, or their global equivalents internationally
Provides leadership in the preparation of regulatory strategies, review of clinical development plans, production of regulatory submission materials, and interactions with health authority for clients.
Provides strategic and tactical guidance to clients, Premier senior management, and project teams to drive backlog and revenue growth across all consulting services while supporting timely and efficient clinical development programs and maintaining full compliance with all regulatory requirements.
Partners with Business Development to cross-sell Premier’s clinical CRO services and supports Marketing-led campaign development and execution with content development expertise.
Presents at applicable industry engagements to project Premier’s expertise in the market and partners with Marketing in the development of resources such as blogs, data sets, etc.
Performs additional duties and assignments as requested from time to time.
What We Are Searching For:
Minimum BS or MS degree in a science-related field. A PharmD or PhD degree is preferred.
Minimum of fifteen years regulatory experience in the pharmaceutical, CRO, biotechnology or consulting industry, involving regulatory submissions in drug development, at least seven years of which should be in a management position in a regulatory affairs department.
Minimum ten years of experience managing a team.
Experience in the preparation of regulatory submissions in the US and/or Europe is required.
Experience with supervisory and financial management responsibilities in a regulatory affairs department of a CRO, pharmaceutical/biotech or consulting firm).
Experience working in multidisciplinary project teams.
Demonstrated skills in complex reasoning, risk management, risk benefit and cost benefit assessments
Demonstrated in-depth knowledge of applicable laws, regulations and guidelines covering the conduct of clinical trials and the submission of regulatory applications in the ICH territories, and a solid working knowledge of regulations regarding the pre-clinical, chemistry, manufacturing and controls, and clinical development in the US and the rest of the world
Demonstrated track record of successful FDA IND applications and product approvals (or the applicable international equivalents).
Excellent written/verbal communication, presentation skills, and an ability to persuade and influence.
Excellent interpersonal, motivational and team building skills
Demonstrated scientific acumen in designated functional/therapeutic domain
Preferred Location: San Francisco or Boston
Premier Research is dedicated to providing compensation that is fair and competitive with market standards. The annualized minimum base pay for this role is $200,000.00 USD. The actual salary will be influenced based on a variety of factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role. We also offer a comprehensive benefits package, which may include health insurance, retirement plans, and paid time off.
Premier Research is proud to be an equal opportunity employer that is compliant with all federal guidelines. All qualified applicants will receive equitable consideration without regard to race, color, religion, sexual orientation, gender identity, national origin, disability or veteran status