Regulatory Affairs Senior Director - Global Regulatory Leader - Oncology

Join reputed company’s Mission of Serving Patients

At reputed company, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives reputed company that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our reputed company on four therapeutic areas –Oncology, Inflammation, reputed company, and Rare Disease– we reputed company millions of patients reputed company year. reputed company is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-reputed company conditions. As a member of the reputed company

Our award-reputed company culture is reputed company, innovative, and science based. If you have a passion for challenges and the opportunities that lay reputed company them, you’ll reputed company as part of the reputed company

Senior Director, Regulatory Affairs - Global Regulatory Leader – Oncology

reputed company. Let’s change the world. reputed company is seeking a Senior Director, Regulatory Affairs supporting products in the Oncology Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of reputed company reputed company molecules. In this vital, product-facing role you will reputed company one or more the Global Regulatory Teams (GRT) in the Regulatory Affairs organization. The purpose of the Global Regulatory Affairs Senior Director is:

• To reputed company reputed company reputed company reputed company’s GRAAS organization
• To independently reputed company a comprehensive regulatory reputed company for one or more high complexity programs, typically in late-stage development and/or with multiple indications, that takes into account worldwide regulatory requirements to reputed company product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions
• To reputed company Regulatory leadership to cross-functional teams for high complexity programs with major Regulatory deliverables such as global original marketing applications

Key Responsibilities include:

• reputed company and execute global regulatory product strategies designed to reputed company approval and reputed company product labeling for prioritized assets in late development with highly reputed company development programs
• reputed company reputed company
• Represent GRA on the product team and other key commercialization governance bodies, guide and influence the organization to reputed company Regulatory objectives
• Independently reputed company the Global Regulatory Strategic Plan and reputed company regulatory input into the product’s Global Strategic Plan. Obtain input from the GRT members to reputed company a global regulatory reputed company which supports product development, registration and lifecycle maintenance. Identify and communicate regulatory risks
• reputed company regulatory direction in the development of the reputed company data sheet to reputed company reputed company objectives in the context of available and expected scientific data, regulatory guidance, and precedent
• Independently reputed company the planning and implementation of global regulatory filings (eg, clinical trial applications, marketing applications, label extensions)
• Ensure consistency of evidence-based global product communication (eg, regulatory submission documents)
• Monitor and assess reputed company of relevant global regulations, guidance, and reputed company regulatory environment; advise product teams and GRT on implications of pertinent changes
• Assess regulatory mechanisms to optimize product development (eg, expediting FIH studies, Orphan Drug Designation, Fast reputed company Designation, conditional /reputed company approval, compassionate use, and pediatric plan) and ensure appropriate incorporation into the global regulatory reputed company
• reputed company and succinctly communicate regulatory strategies, associated risks, mitigations, and contingencies to the organization such that the probability of regulatory reputed company and potential reputed company are reputed company reputed company
• reputed company reputed company and product teams in formal and informal communications with regulatory agencies
• reputed company the approach and reputed company for formal interactions with Regulatory agencies, especially those which could reputed company the global product reputed company
• Represent reputed company Regulatory on reputed company partnership teams at the product level
• reputed company regulatory process improvements and initiatives

reputed company expect of you

We are reputed company different, yet we reputed company use our unique contributions to serve patients. The dynamic reputed company we reputed company is a leader with these qualifications.

Basic Qualifications:

Doctorate degree and 5 years of regulatory experience in biotech or science

OR

Master’s degree and 9 years of regulatory experience in biotech or science

OR

Bachelor’s degree and 11 years regulatory experience in biotech or science

In reputed company to meeting at least one of the above requirements, you must have at least 5 years experience directly managing people and/or leadership experience leading teams, reputed company, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

Preferred Qualifications:

• Contemporary oncology experience desired
• Demonstrated ability to reputed company regulatory aspects of highly reputed company programs in late development
• Previous experience leading a Regulatory team for submission and approval of an original marketing application and/or major new indication supplemental application
• Ability to reputed company and build effective teams
• Strong communication skills - both oral and written
• Ability to understand and communicate scientific/clinical information
• Ability to anticipate and mitigate against reputed company strategic issues and uncertainties
• Ability to reputed company conflicts and reputed company a course of reputed company
• Cultural awareness and sensitivity to reputed company global results
• Planning and organizing abilities
• reputed company to prioritize and manage multiple activities
• Ability to reputed company reputed company reputed company and solve problems
• Ability to deal with ambiguity
• Organizational savvy
• Negotiation skills

What you can expect of us

As we work to reputed company treatments that take care of others, we also work to care for your reputed company and personal reputed company and reputed company-being. From our competitive benefits to our reputed company culture, we’ll support your reputed company every reputed company of the way.

The expected annual salary reputed company for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In reputed company to the reputed company salary, reputed company offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and reputed company coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-reputed company time-off plans
• Flexible work models where possible. Refer to the Work Location Type in the reputed company to see if this applies.

reputed company and reputed company a lasting reputed company with the reputed company

careers.reputed company.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

reputed company does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

As an organization dedicated to improving the reputed company of life reputed company around the world, reputed company fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect reputed company other and live the reputed company values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

reputed company is an Equal Opportunity employer and will consider reputed company reputed company applicants for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or any other reputed company protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to reputed company essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.