SummaryThis role directs, manages, evaluates and implements regulatory projects in support of company goals in the area of clinical strategy. The position will play a major role in shaping cohesive regulatory strategy across the assigned programs and ensuring effective integration of broad regulatory ideas/tactics supporting program/platform strategy. This role's responsibilities may be global, regional, or local based on programs status.
ResponsibilitiesEssential Duties & Responsibilities:The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.
Regulatory Affairs Clinical-Nonclinical Strategy - Lead the development of regulatory strategy for multiple and/or complex projects (from first-in-human to post-marketing application stage) outlined in Global Regulatory Strategy Documents, including for regulatory submissions documents and HA communications.
- Analyze and address complex issues, providing advanced regulatory solutions and guidance to cross-functional teams and regulatory leadership. Advise senior management on status of global regulatory affairs strategies and tactics, practice, and procedures.
- Align with cross-functional teams to lead the development and management of project plans and timelines, followed by effective execution of the plan by ensuring all projects are appropriately prioritized and key goals are met on time.
- Influence regulatory environment by active participation in relevant conferences, trade associations, industry/agency regulatory meetings, committees; remain up-to-date on changing regulatory environment, and provide regulatory policy and intelligence including competitive issues that influence regulatory strategy.
Leadership- Supervise and mentor direct reports to facilitate professional growth; identify training opportunities and provide mentoring to ensure individuals are appropriately developed in accordance with their roles and responsibilities.
- Identify resourcing needs and appropriate allocation activities to internal and external support.
- Drive continuous process improvements to enable an efficient and lean organization.
- Support budgeting and forecasting for function and Regulatory Affairs department.
- Manage vendors and contractors as applicable.
- Other responsibilities as needed.
Supervisory Responsibilities:This position may have direct supervisory responsibilities.
QualificationsEducation and Experiences- Bachelor 's degree in a life science with a minimum of 10 years progressively responsible experience in Regulatory Affairs in the U.S. pharmaceutical industry; or
- Master's degree in a life science with a minimum of 8 years progressively responsible experience in Regulatory Affairs in the U.S. pharmaceutical industry; or
- Doctoral (M.D., Ph.D., Pharm.D., etc.) degree with a minimum 6 years progressively responsible experience in Regulatory Affairs in the U.S. pharmaceutical industry
- Managerial experience desirable
Knowledge and skills:- Demonstrated expertise in creating and assessing proposals to regulatory authorities on regulatory paths and clinical plans, and in leading productive health authority interactions, including well organized preparation of cross functional teams
- A business-minded leader, capable of strategic thinking and proposing innovative solutions to regulatory problems
- Must have demonstrated advanced proficiency in analyzing and interpreting data, protocols, safety reporting, labeling, and other activities related to the phases of drug development for assigned products
- Demonstrated expertise in analyzing the adequacy of proposed regulatory pathways and strategies and guiding development teams with recommendations for change/refinements based on ongoing regulatory outcomes throughout development
- Able to articulate the organization's strategic vision and core values, and successfully contribute to improving the quality of internal regulatory policies, programs, and initiatives
- Demonstrates excellent communication skills with ability to impact and influence the decisions of a team, communicates with all levels within the company and act as liaison/representative both internally and externally, and communicates effectively in writing and in verbal presentations regulatory strategy plans and submission documents
- Demonstrated ability to provide regulatory leadership on a cross-functional team and work effectively in a matrix environment
- Demonstrated technical expertise in regulatory affairs science including advanced knowledge of regulatory frameworks and external environments
- Expert knowledge of global/regional/local regulatory legislation, laws, procedure, and guidance for pharmaceutical development of medicines for human use, with demonstrated knowledge of the research and development, nonclinical and clinical requirements related to drug development, registration, and maintenance of human pharma. Excellent written and oral English communication skills
- Experience working within, and potentially managing, the Medical, Legal and Regulatory review process of promotional materials
- Experience and knowledge in the preparation of and post-approval management of prescription drug, biological, and/or medical device labeling
- Experience working with FDA's OPDP and submission of promotional materials
- Advanced knowledge of regulations and guidances related to the commercialization of pharmaceutical, biological, and/or medical device products in the US; experience in other global regions is preferred
- Outstanding written and verbal communication skills
- Excellent analytical and critical thinking skills
- Demonstrated negotiation and problem-solving skills
- Strong project management skills with keen attention to detail
- Expert knowledge of MS Word and ability to ensure adherence to internal templates and standards for regulatory submission documents
- Results-oriented with an enthusiastic attitude and strong interpersonal skills
- Proven attention to detail, while at the same time seeing the big strategic picture
Benefits- Medical, Prescription, Dental, Vision Coverage
- Flexible Spending Account & Health Savings Account with Company match
- Employee Assistance Program
- Mental Health Resources
- Disability Coverage
- Life insurance
- Critical Illness and Accident Insurance
- Legal and Identity Theft Protection
- Pet Insurance
- Fertility and Maternity Assistance
- 401(k) with company match
- Flexible Time Off (FTO) and 11 paid holidays
- Paid Parental Leave
Pay TransparencyThe base pay range for this role is $203,000 annually to $267,000 annually.
The range is what we reasonably expect to pay for this role. The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications.
