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Boehringer Ingelheim · 4 days ago

Director, US Regulatory Affairs Pharmaceuticals

Duluth, GA

Full-time

Onsite

Director/Executive

15+ years exp

Boehringer Ingelheim is a global leader in the pharmaceutical industry, dedicated to improving lives through innovative healthcare solutions. The Director, US Regulatory Affairs Pharmaceuticals will lead the US Regulatory Affairs organization, ensuring compliance and effective communication with regulatory authorities while managing a team to support the Animal health portfolio.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

Leads and is accountable for external representation: Key communication interface and influencer with Regulatory Authorities

Responsible for proactively seeking contact with Authorities directly in the USA or through local RA as appropriate and positioning BI as a trusted and innovative partner (key account management)

Ensures a balanced relationship with the authorities

Is a highly effective communicator with external authorities, agencies and internal stakeholders and senior leadership

Provides clarity and interpret relevant legislation and translate into actionable areas to increase the predictability and probability of success for our projects and activities

Works globally and closely in cooperation and collaboration with other RA leadership positions in the best interests of the global team ensuring agility, accountability and intrapreneurship across the function

Leads regulatory support for Authority site inspections and provides leadership and advice to Clinical, GS and Quality

Works globally and closely in cooperation and collaboration with other RA leadership positions in best interests of the global team to maintain agility, accountability and intrapreneurship across the function

Leads leaders and technical experts and mentors regulatory teams and colleagues globally, providing innovative solutions to challenges of the organization and our portfolio

Responsible for hiring, retaining and developing Regulatory team members and identifying talent for future success

Seeks ways to measure and increase team engagement and productivity

Ensures functional excellence of members and promotes an entrepreneurial and proactive spirit

Demonstrates and promotes Our Behaviors with key stakeholders

Responsible for managing cost center and budget for function and associated activities

Ensures integrity of our regulatory compliance with the respective authorities

Provides service to all our operations in the respective scope of their responsibilities: Global Innovation, Global Supply, Strategic business units, Commercial operations including local RA teams in international locations

Is an internal service provider who is responsible (and accountable) for leading a team which:

Proactively and in an entrepreneurial manner provides guidance to GI project teams for optimal registration strategies in the USA, balancing compliance and risk factors with speed to market

Prepares, submits and achieves marketing authorizations in a timely manner, achieving a competitive label

Professionally and proactively addresses needs of internal stakeholders with urgency

Is responsible for increasing productivity that maximizes product lifecycle opportunities in line with business strategy

Is responsible for maintaining up to date technical regulatory data and information for use in dossier preparation for BI submissions to Authorities

Develops and implements strategies for quick resolutions of regulatory issues arising during the post approval and re-registration cycle

Responsible for identifying regulatory trends and driving strategies to manage and address in the interests of BI

Qualification

Regulatory Affairs ExpertiseLeadership SkillsTeam CollaborationLife Sciences DegreeFluent in EnglishChange ManagementCommunicationNegotiation SkillsMentoring Skills

Required

Bachelor's degree required in Life Sciences such as Biology, Toxicology, Pharmacy or equivalent with fifteen (15) years of experience

Fluent in English

Expertise in Regulatory affairs is required with extensive authority interactions and a strong track record of successful influencing

Proven leader with demonstrated ability to build and lead high performing teams

Strong team player

Demonstrated ability to successfully collaborate and lead people in a complex global organization

Excellent communicator and negotiator with ability to form successful working relationships at all levels across disciplines and geographies

Exhibits Our Behaviors

Enthusiastic mentor, coach and developer of people

Self-motivated decision maker, well organized, works to deadlines and with a high degree of initiative and persistence

Experience building an organization and leading change management

Willingness to travel up to 20%

Must be legally authorized to work in the United States without restriction

Must be willing to take a drug test and post-offer physical (if required)

Must be 18 years of age or older

Preferred

Advanced degree e.g. PhD, Veterinary medicine or Medicine strongly preferred

Benefits

Competitive compensation and benefit programs

Programs and groups that ensure your health and wellbeing are looked after

Company

Boehringer Ingelheim

Glassdoor4.2

Boehringer Ingelheim is a group of pharmaceutical companies that focuses on prescription medicines and animal health. It is a sub-organization of Boehringer Ingelheim.

Founded in 1885

Ingelheim Am Rhein, Rheinland-Pfalz, DEU

10001+ employees