Current jobs related to Executive Vice President of Regulatory Affairs - City of Daşşak - Dennis Partners
-
Academic Affairs Vice President
1 week ago
Maryland City, Maryland, United States Capitol Technology University Full timeAcademic Leadership OpportunityCapitol Technology University, a leading institution in Maryland dedicated to engineering, computer science, and information technology, seeks a visionary leader to serve as its next Vice President, Academic Affairs. Reporting to the President, the successful candidate will be responsible for overseeing all academic programs,...
-
Business Affairs Vice President
3 weeks ago
Universal City, California, United States NBC Universal Media, LLC Full timeJob Title: Vice President, Business AffairsAt NBCUniversal, we're committed to creating a diverse and inclusive workplace where our employees feel valued and empowered to succeed. As a Vice President, Business Affairs, you'll play a critical role in shaping the future of our company by negotiating and managing agreements for scripted programming across...
-
Vice President of Business Affairs
1 month ago
Universal City, California, United States NBC Universal Media, LLC Full timeJob Title: Vice President, Business AffairsCompany Description:NBCUniversal is a leading media and entertainment company that creates and distributes world-class content across its portfolio of film, television, and streaming platforms. We own and operate leading entertainment and news brands, including NBC, NBC News, MSNBC, CNBC, NBC Sports, Telemundo, and...
-
King of Prussia, Pennsylvania, United States CSL Behring Full timeJob Title: Vice President, Head of Therapeutic Areas, Medical AffairsThe Vice President of Medical Affairs, Therapeutic Areas will provide strategic medical leadership across all CSL products, pipeline, and inline. This critical role will drive medical strategy and execution excellence, enabling R&D strategy and commercial growth objectives through evidence...
-
Tax Vice President – Structuring Expert
1 month ago
City of Daşşak, United States Northbound Executive Search Full timeTax Structuring VP – NYC Asset ManagementWe are seeking a highly skilled Tax Vice President to join our team at Northbound Executive Search. The ideal candidate will have a strong background in tax structuring, with a focus on US distressed assets, real estate, and structured products.Key Responsibilities:Develop and implement tax structuring strategies...
-
Regulatory Reporting Vice President
3 weeks ago
Jersey City, New Jersey, United States SMBC Full timeJob Title: Regulatory Reporting Vice PresidentSMBC Group is a leading global financial institution with a rich history and diverse range of financial services. As a Regulatory Reporting Vice President, you will play a critical role in ensuring the accuracy and timeliness of our regulatory reports.Key Responsibilities:Oversee the preparation and review of...
-
Regional Vice President Commercial Lines
4 weeks ago
Oklahoma City, Oklahoma, United States Hanover Insurance Company Full timeRegional Vice President, Commercial LinesAt Hanover Insurance Company, we are seeking a highly skilled and experienced Regional Vice President to lead our Commercial Lines team in Somerset County, New Jersey. As a key member of our leadership team, you will be responsible for driving profitable growth in the assigned territory, executing business plans, and...
-
King of Prussia, United States CSL Behring Full timeThe Vice President of Medical Affairs Therapeutic will provide strategic medical leadership across all CSL products, pipeline and inline. This is a critical role to drive medical strategy and execution excellence, enabling R&D strategy and enabling commercial growth objectives through evidence generation, thought leadership, scientific engagement and product...
-
Regulatory Officer, Vice President
2 weeks ago
Jersey City, New Jersey, United States SMBC Full timeJob Title: Regulatory Officer, Vice PresidentSMBC Group is a leading global financial institution with a rich history spanning over 400 years. Headquartered in Tokyo, we offer a diverse range of financial services, including banking, leasing, securities, credit cards, and consumer finance. Our global presence extends to nearly 40 countries, with over 130...
-
Regulatory Officer, Vice President
2 weeks ago
Jersey City, New Jersey, United States SMBC Full timeJob Title: Regulatory Officer, Vice PresidentSMBC Group is a leading global financial institution with a rich history spanning over 400 years. Headquartered in Tokyo, we offer a diverse range of financial services, including banking, leasing, securities, credit cards, and consumer finance. Our global presence extends to nearly 40 countries, with over 130...
-
King of Prussia, Pennsylvania, United States CSL Behring Full timeJob SummaryWe are seeking a highly experienced and skilled Vice President, Head of Therapeutic Areas, Medical Affairs to lead our medical strategy and execution excellence across all CSL products, pipeline, and inline. This critical role will drive medical strategy and execution, enabling R&D strategy and commercial growth objectives through evidence...
-
King of Prussia, United States CSL Full timeThe Vice President of Medical Affairs Therapeutic will provide strategic medical leadership across all CSL products, pipeline and inline. This is a critical role to drive medical strategy and execution excellence, enabling R&D strategy and enabling commercial growth objectives through evidence generation, thought leadership, scientific engagement and product...
-
King of Prussia, United States CSL Behring Full timeThe Vice President of Medical Affairs Therapeutic will provide strategic medical leadership across all CSL products, pipeline and inline. This is a critical role to drive medical strategy and execution excellence, enabling R&D strategy and enabling commercial growth objectives through evidence generation, thought leadership, scientific engagement and product...
-
King of Prussia, United States CSL Behring Full timeThe Vice President of Medical Affairs Therapeutic will provide strategic medical leadership across all CSL products, pipeline and inline. This is a critical role to drive medical strategy and execution excellence, enabling R&D strategy and enabling commercial growth objectives through evidence generation, thought leadership, scientific engagement and product...
-
King of Prussia, United States CSL Behring Full timeThe Vice President of Medical Affairs Therapeutic will provide strategic medical leadership across all CSL products, pipeline and inline. This is a critical role to drive medical strategy and execution excellence, enabling R&D strategy and enabling commercial growth objectives through evidence generation, thought leadership, scientific engagement and product...
-
King of Prussia, United States CSL Behring Full timeThe Vice President of Medical Affairs Therapeutic will provide strategic medical leadership across all CSL products, pipeline and inline. This is a critical role to drive medical strategy and execution excellence, enabling R&D strategy and enabling commercial growth objectives through evidence generation, thought leadership, scientific engagement and product...
-
Vice President, Tax Manager
2 months ago
City of Daşşak, United States Emigrant Bank Full timePosition: Vice President, Tax Manager Department: Finance and Ops Reports To: First Vice President, Sr. Tax Specialist Employment Status: Full-Time, Exempt Office Location: Hybrid, NYC Job Summary This role will play a pivotal role in overseeing the day-to-day operations of the tax function, managing key tax initiatives, and ensuring compliance with all...
-
Tax Vice President
1 month ago
City of Daşşak, United States Emigrant Bank Full timeJob Title: Vice President, Tax ManagerJob Summary:This role will play a pivotal role in overseeing the day-to-day operations of the tax function, managing key tax initiatives, and ensuring compliance with all applicable tax laws and regulations. The candidate will assist with compliance, planning, research, and tax dispute resolution.Key...
-
King of Prussia, Pennsylvania, United States CSL Behring Full timeJob SummaryThe Vice President, Head of Therapeutic Areas, Medical Affairs will provide strategic medical leadership across all CSL products, pipeline, and inline. This critical role will drive medical strategy and execution excellence, enabling R&D strategy and commercial growth objectives through evidence generation, thought leadership, scientific...
-
King of Prussia, PA, United States CSL Behring Full timeThe Vice President of Medical Affairs Therapeutic will provide strategic medical leadership across all CSL products, pipeline and inline. This is a critical role to drive medical strategy and execution excellence, enabling R&D strategy and enabling commercial growth objectives through evidence generation, thought leadership, scientific engagement and product...
Executive Vice President of Regulatory Affairs
2 months ago
This is a confidential search. Dennis Partners, a clinical stage biopharmaceutical firm, is advancing a pioneering pipeline of oncology treatments. They are in search of a Senior Vice President of Regulatory Affairs to manage their Regulatory, Quality, and Medical Writing divisions. Reporting directly to the President and Head of R&D, you will spearhead the formulation of global regulatory strategies and lead engagements with Health Authorities while overseeing a growing team. This organization boasts an innovative pipeline, a robust financial position, and a collaborative culture. With two programs on the brink of FDA approval, this is an exciting opportunity to contribute to the organization's success.
Key Responsibilities:
- Formulate, direct, and implement global regulatory strategies for a range of innovative oncology programs across all development phases.
- Supervise and ensure the timely preparation of precise regulatory submissions, including INDs, CTAs, NDAs, and MAAs, while maintaining compliance with regulatory requirements.
- Guarantee adherence to the latest Health Authority and Industry submission standards in both the US and EU.
- Lead engagements with the FDA and other Health Authorities.
- Establish departmental standards to ensure the highest quality of submitted information.
- Ensure that electronic submissions and documents comply with regulatory agency and company submission standards and technical requirements.
- Collaborate with executive management to maximize the potential value of programs.
- Maintain effective relationships with vendors.
- Oversee regulatory reviews for the upcoming launches of multiple products.
- Ensure that development programs are on track to meet defined objectives and timelines.
- Recruit, guide, and develop appropriate internal and external resources to achieve program goals.
- Construct the company's quality system; devise the company's GMP, GLP, and GCP compliance strategies, and provide support for all clinical development initiatives.
- In close collaboration with the Head of QA, oversee GMP, GLP, and GCP compliance audits (both domestic and international), including contract manufacturing sites, analytical testing sites, clinical storage and distribution sites, clinical investigator sites, contract test laboratories, and CROs to assess compliance status and identify risks.
- In partnership with the Head of QA, supervise QA reviews of GMP manufacturing batch records, product release and stability testing, validation reports, pharmacology and toxicology study reports, and essential clinical study documents.
- In a cross-functional capacity, evaluate all GMP, GLP, and GCP compliance risks associated with clinical development programs and develop and implement risk mitigation strategies.
- Develop and enforce standards, policies, and procedures for GMP, GLP, and GCP compliance as necessary.
- Build a strong Regulatory Affairs and Quality team to support clinical development programs.
- Mentor and develop regulatory and quality personnel.
- Forecast budgets and establish department best practices and SOPs.
- Bachelor's degree in a scientific discipline; advanced degree (MS, PharmD, or PhD) preferred.
- Minimum of 15 years of experience in Regulatory Affairs within pharma/biotech organizations.
- Extensive Regulatory experience in the oncology therapeutic area is essential.
- Proven track record of leading regulatory activities for product launches.
- Demonstrated technical leadership in successful submissions to regulatory agencies.
- Strong experience in managing successful interactions with the FDA and other health authorities.
- Robust ex-US Regulatory experience, preferably with EU/EMA.
- Comprehensive understanding of drug development and the integration of activities necessary to achieve objectives.
- Experience in Quality Assurance and oversight of QA functions.
Leadership, Interpersonal, and Soft Skills:
- Proven experience in leading Regulatory teams.
- Strong ability to influence and build credibility with both internal and external stakeholders.
- Possess the gravitas and executive presence to present to the executive leadership team.
- Ability to navigate a consensus-driven environment through teamwork, trust, and shared expectations, influencing strategic direction.
- Capacity to foster collaborative relationships both internally and externally.
- Aptitude to inspire, motivate, and develop Regulatory and Quality teams.
- Excellent communication and presentation skills.
- Adaptable to changing circumstances; strategic thinker and problem-solver.
- Comfortable with ambiguity in a fast-paced, small company environment.
This is a hybrid onsite position. Local candidates are preferred. Must be in the office 2-3 days per week.
The budgeted salary range for this position is US$375,000 to $425,000 plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may vary based on factors including, but not limited to, a candidate's skill set, experience, education, and other qualifications.
