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Description

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Executive Director, Regulatory Affairs Excellence is responsible to establish and promote a culture of excellence across all areas of the regulatory affairs department. This leadership role focuses on the strategic integration of internal priorities across functions and external regulatory and scientific trends to identify and prioritize regulatory affairs capabilities to be enhanced in GRA. The incumbent will also be responsible to translate the analysis in tangible plans which will help to deliver the enhanced capabilities.

The ED, Regulatory Affairs Excellence will be a continuous change agent within GRA and drive innovation, foster collaboration, and oversee the development and implementation of best practices to achieve the organization's regulatory objectives and maintain compliance with global regulatory requirements. Therefore, this role will have a direct impact on the efficient translation of HP, Therapeutic Areas, and asset strategies into competitive regulatory strategies.

This position can be filled in Germany (Ingelheim) or the US.

• If you want to apply for the position in Germany, please use this link:

• If you want to apply for the position in the US, click "Apply now".

We kindly ask you to apply for the Boehringer Ingelheim location that is closest to your country of residence. Please, do not apply for more than one location!

*Upon applying for this position, you will encounter a query regarding the visibility of your profile - whether it should be confined to the recruiters managing the jobs you apply to, or be accessible to any company recruiter worldwide. Given that the hiring manager is not based in the country you are applying for and the interview process is performed in the hiring manager country, we kindly urge you to opt for "Any company recruiter worldwide". This action will greatly assist us in processing your application in the most efficient manner, while ensuring compliance with the General Data Protection Regulation.

Duties & Responsibilities

• Works with those leaders and in alignment with GRA priority areas to convert the insights gained from analyzing internal and external trends into practical plans that facilitate the improvement of regulatory affairs capabilities in GRA.

• Leads the Regulatory Excellence group leads and the Capability Leaders for Development, Market Authorization, and the GRA Compliance and vendor oversight groups.

• Responsible for harmonizing internal priorities across various functions and incorporating external regulatory and scientific trends to determine and prioritize the enhancement of regulatory affairs capabilities within GRA.

• Leads the Regulatory Performance and Analytics lead and in collaboration drives the execution of benchmarking exercises and KPIs that go beyond the responsibility of one GRA function to gage performance and innovation compared to competitors.

• Partners across Medicine, ROPU/OPUs, TAs and other functional partners to identify areas for improvement for GRA.

• Displays and instills strong external engagement and focus of the group to drive continuous improvement and drive competitive advantage of GRA at BI with a focus on the way of operating.

• Leads the team of Regulatory Project Managers to develop and implement regulatory strategies-based plans for projects, ensuring alignment with organizational objectives and compliance with relevant regulations and guidelines.

• Drives the team's ability to strategically plan, coordinate, and execute regulatory submissions ensuring they are delivered on time.

• Leads GRA transformation projects to design and implement effective change management strategies to facilitate the adoption of new processes, systems, and organizational structures, ensuring minimal disruption to ongoing operations.

• Actively engages with key stakeholders, including senior leadership, employees, and external partners, to build support for the transformation initiatives and address any concerns or resistance.

• Builds and maintains a highly skilled workforce of energized employees through hiring, developing, and retaining talents.

Requirements

• Minimum requirement: Master's degree in pharmacy, life sciences or chemistry.

• Preferred: Doctoral Degree (e.g., PhD) in pharmacy, life sciences or chemistry.

• Further degrees/certifications: Specialized Pharmacist or Master of Drug Regulatory Affairs, RAC certification.

Technical expertise:

• Long-term (10+ years) experience in regulated pharmaceutical industry (biologics or small molecule)

• Possesses extensive connections and a profound understanding of the organization, along with a comprehensive knowledge of relevant internal SOPs/working instructions and in-depth familiarity with international regulatory guidance documents.

• Demonstrates mastery in regulatory science and global regulatory requirements, guidelines, developments, and standards, providing informed and influential input to a wide range of key regulatory documents, challenges, and infliction points.

• Demonstrates exceptional expertise in technical excellence across core areas of drug development, proficiently analyzing and interpreting complex data and regulatory guidelines.

• Translates regulatory guidance into strategic project proposals and proactively offers authoritative guidance, crafting compliant, innovative, and well-considered regulatory solutions to address emergent issues.

• Possesses superior commercial acumen, deeply understanding the business environment, needs, and priorities of the company, significantly impacting the success of projects.

• Functions with high autonomy and efficiency, requiring minimal escalation, even in complex strategic situations.

Soft skills:

• Strong leadership to influence others with the ability to create a broad networker of stakeholders. Critical thinker with ability to self-direct workload, including prioritizing and delivering under the most demanding timelines with precision and efficiency.

Exceptional strategic mindset & thinking, with the ability to step out of everyday details and provide a top-down view, i.e.:

• Shape and evolve the RA ambition.

• Anticipate both complex opportunities and challenges in execution.

• Excels at problem-solving, contextualizing, decision-making with profound understanding of the implications, developing realistic action plans to achieve specific goals and laying out risks.

• Willingness to challenge conventional thinking and adapt considering new information.

Adaptability, learning agility and flexibility in navigating changing regulatory environment and adapt strategies accordingly, including:

• Agile & collaborative ways of working in development of new ideas and solutions.

• Continuous improvement mindset for both individual and team development.

• Demonstrates continuous learning, seeks feedback, and reflects on performance for personal growth and improvement.

Desired Skills, Experience and Abilities

Additional Duties & Responsibilities:

Can-do attitude and a proactive approach to work, demonstrating a willingness to take ownership and find solutions for addressing regulatory challenges and opportunities, including:

• Self-directed and future-focused attitude to ‘make things happen’ – willingness to go the extra mile, learn from potential failures and pursue excellence.

• Taking initiative by anticipating events or problems before they occur, looking beyond the current situation, seeking information and other’s concerns, and generating further insights.

• Effective leadership and team management skills to influence, confidently influencing and inspiring cross-functional teams with a visionary approach in an independent manner with an overall strategic view and strong business acumen, leveraging the team’s knowledge and expertise and empowering them to contribute fully to the joint project success.

• Strong interpersonal skills, relationship building, sound conflict management skills.

• Excellent verbal and written communications skills with the ability to provide key messages in a concise, top-down manner for effective interactions with internal / external (senior) stakeholders and regulatory authorities.

• Ability to summarize complex scientific and regulatory questions into easy-to-read slides and text.

• Ability to prepare scenarios and decision trees, helping decision-making within the evidence and asset teams.

• Strong organizational and time management skills to manage multiple projects at once, meet deadlines, drive the delivery of the best possible output and work well under pressure.

• Fluency with necessary computer software (MSWord, Excel, Project, etc.) and willingness to embrace further opportunities presented by emerging technological advances.

Special skills:

In-depth knowledge in RA:

• Exercises exceptional business acumen to align regulatory strategies seamlessly with overarching business objectives, strategically leveraging regulatory insights to drive successful outcomes.

• Exhibits a profound ability to discern complex and non-routine regulatory issues, showcasing effective leadership by offering options and jointly developing regulatory solutions.

• Defines regulatory standard requirements for compliance with accepted standards and regulations.

Eligibility Requirements :

• 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.

Compensation :

This position offers a base salary typically between $200,000 and $347,000. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements.  For an overview of our benefits please click here. (https://www.boehringer-ingelheim.com/us/careers/benefits-rewards)

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.