Boehringer Ingelheim
Director, Global Regulatory Strategy Lead
Boehringer Ingelheim, Ridgefield, Connecticut, us, 06877
Director, Global Regulatory Strategy Lead
Join to apply for the
Director, Global Regulatory Strategy Lead
role at
Boehringer Ingelheim
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to patients and customers. Our global presence provides opportunities for collaboration internationally, visibility, and a chance to directly contribute to the company’s success. We support employees in fostering a healthy working environment, meaningful work, mobility, networking, and work‑life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim’s commitment to our people.
The Director, Global Regulatory Strategy Lead will provide strategic regulatory guidance and leadership throughout the product lifecycle on assigned projects. They will develop and own the Global Regulatory Strategy for assigned assets, lead the Regulatory Excellence Team (RET), and represent Global Regulatory Affairs (GRA) on the Evidence Team. They will craft comprehensive regulatory strategies to navigate the global regulatory landscape, ensure compliance with guidelines, assess regulatory risks, anticipate challenges, and propose innovative solutions to accelerate development and approval.
Duties & Responsibilities Regulatory professionalism
Effectively lead with in‑depth expertise in at least one therapeutic area and a broad range of global regulatory and drug development topics.
Seamlessly interact and collaborate cross‑functionally at all levels of the organization.
Drive project goals effectively, efficiently, and proactively, presenting well‑grounded, strategically thought‑through options and arguments to achieve successful regulatory outcomes.
Maintain the highest standards of professionalism, ethics, and regulatory compliance.
Global regulatory strategy
Lead the development and implementation of well‑informed, cutting‑edge strategic regulatory guidance and leadership of assigned projects, in collaboration with the RA sub team / RET and Evidence Team.
Assess and present regulatory risks, options, and opportunities, anticipate challenges, and propose innovative solutions to accelerate development and approval, leveraging the full breadth of regulatory pathways and the most up‑to‑date regulatory science.
Support pivotal moments in the lifecycle of assigned projects in close alignment to Evidence & Asset Teams.
Account for and optimize global regulatory strategy contributions around global business goals, focus country prioritization, and regional requirements.
Anticipate regulatory hurdles and proactively plan strategies to overcome them.
Collaborate closely with stakeholders across the organization to align regulatory strategies with overall business objectives.
Further asset development activities
Collaborate with stakeholders on early target label profile shaping to ensure labeling is aligned with regulatory requirements and business objectives.
In cooperation with Global Labelling, provide global regulatory input into the content of the draft Company Core Datasheet; support RET members in regional/local discussions related to the content of drug labeling during development, submission preparation, submission review, and product lifecycle.
Oversee the planning and execution of regulatory submissions coordinated by the Regulatory Project Manager.
Support submission rollout for Rest of World (RoW) countries from the global strategic perspective.
Registration & lifecycle management
Contribute to and oversee execution of strategies for the lifecycle management of assigned marketed products, including assessing the need for post‑approval changes such as variations, supplements, and line extensions, and developing regulatory plans to implement these changes globally.
Collaborate with Evidence & Asset teams to ensure alignment with business goals and regulatory requirements.
Regulatory intelligence
Stay up to date with and evaluate relevant worldwide regulations and guidelines, evolving regulatory trends and developments, and determine impact on drug development activities and existing strategies, products and submissions.
Proactively communicate the impact of regulatory changes to internal stakeholders and provide recommendations on adapting regulatory strategies.
Develop and advise on contingency plans for assigned projects.
Provide timely risk/benefit analyses of issues affecting products/projects.
Continuously scan the relevant environment for innovative regulatory pathways and perform insightful competitive landscape analysis.
Requirements
Bachelor’s degree in pharmacy, life sciences or chemistry with seven (7) years’ experience in the regulated pharmaceutical industry (biologics or small molecule) required.
Preferred: Master’s Degree or Doctoral Degree (e.g., PhD) in pharmacy, life sciences or chemistry with five (5) years’ experience in the regulated pharmaceutical industry (biologics or small molecule).
Further degrees/certifications: Specialized Pharmacist or Master of Drug Regulatory Affairs, RAC certification.
Technical expertise
In‑depth knowledge of latest regulatory science and global regulatory requirements, guidelines, developments, and standards, allowing for informed comments and input to a broad spectrum of key regulatory documents, challenges, and inflection points.
Demonstrated thorough understanding of the regulatory process and technical competence in core areas of drug development; can analyze and interpret complex scientific data and regulatory guidelines.
Interprets and translates regulatory guidance to project‑specific proposals and proactively provides guidance to the creation of compliant, strategically thoughtful and innovative regulatory solutions to emergent issues.
Commercially aware and has a thorough understanding of the business environment, needs and priorities of the company, the assigned therapeutic area and the contribution of specific assigned development and PMO projects.
Able to work autonomously in a highly efficient manner.
Soft skills
Critical thinker with ability to self‑direct workload, including prioritizing and delivering under tight timelines.
Strong strategic mindset & thinking, with the ability to step out of everyday details and provide a top‑down view.
Adaptability, learning agility and flexibility in navigating changing regulatory environments and adapting strategies accordingly.
Can‑do attitude and a proactive approach to work, demonstrating a willingness to take ownership and find solutions for addressing regulatory challenges and opportunities.
Effective leadership and team management skills.
Strong interpersonal skills, relationship building, sound conflict management skills.
Excellent verbal and written communications skills.
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.
Fluency with necessary computer software (MSWord, Excel, Project, etc.).
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.
Desired Skills, Experience And Abilities Regulatory policy & external stakeholder interactions
Contribute to global strategy and for meetings with health authorities for drug development goals in alignment with Evidence and Asset Team and RET.
Collaborate to define the policy and environment shaping goals, regional‑specific questions and content.
Provide guidance and input to regulatory agency meetings including briefing documentation.
Provide global regulatory input to critical safety or quality communications.
Maintain global oversight of local RA activities in responding to local health authority questions.
Attend and seek out Health Authority meetings for assigned projects.
Stay informed about evolving regulatory expectations, provide input on policy developments, and contribute to shaping regulatory frameworks for better patient outcomes.
External / internal assessments, external partners
Participate and support internal and external pre‑evaluations and contribute to assessment reports.
For projects with a licensing partner, fulfill RA tasks as outlined in the licensing contract.
Proactively drive continuous improvement and increasing efficiencies.
RA sub team leadership
Ensure active involvement in shaping robust strategies aligned with business goals.
Encourage innovative thinking and a proactive approach to anticipate regulatory challenges & opportunities.
Oversee up‑to‑date project information shared by Regulatory Project Manager to ensure sub team members can fulfill their assigned tasks and seek input from RA sub team / RET to accurately reflect global regulatory requirements and challenges in the Evidence Team.
Responsible for the GRA contribution to key project‑related documentation.
Ensure the sub team / RET is appropriately staffed and possesses the necessary skills.
Mentoring
Act as a mentor to foster a collaborative environment where team members can seek feedback and discuss challenges.
Encourage the sharing of experiences and best practices.
Contribute to internal training programs, workshops, and knowledge‑sharing sessions.
Attend relevant conferences, workshops, webinars, and professional development courses such as Advanced Analytics or AI and become a translator on how to use these technologies.
This position offers a base salary typically between $220,000 and $350,000. 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 consult the company benefits website.
Our Company Why Boehringer Ingelheim? With us, you can develop your own path in a company with a culture that knows our differences are our strengths – and break new ground in the drive to make millions of lives better. Here, your development is our priority. We support you to build a career in a workplace that is independent, authentic, and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed. Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after – as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you will be helping to transform lives for generations. Visit https://www.boehringer-ingelheim.com for more information.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Legal
Industries Pharmaceutical Manufacturing
If you want to apply for the position in Germany, please use this link: https://jobs.boehringer-ingelheim.com/job-invite/25587/.
#J-18808-Ljbffr
Director, Global Regulatory Strategy Lead
role at
Boehringer Ingelheim
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to patients and customers. Our global presence provides opportunities for collaboration internationally, visibility, and a chance to directly contribute to the company’s success. We support employees in fostering a healthy working environment, meaningful work, mobility, networking, and work‑life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim’s commitment to our people.
The Director, Global Regulatory Strategy Lead will provide strategic regulatory guidance and leadership throughout the product lifecycle on assigned projects. They will develop and own the Global Regulatory Strategy for assigned assets, lead the Regulatory Excellence Team (RET), and represent Global Regulatory Affairs (GRA) on the Evidence Team. They will craft comprehensive regulatory strategies to navigate the global regulatory landscape, ensure compliance with guidelines, assess regulatory risks, anticipate challenges, and propose innovative solutions to accelerate development and approval.
Duties & Responsibilities Regulatory professionalism
Effectively lead with in‑depth expertise in at least one therapeutic area and a broad range of global regulatory and drug development topics.
Seamlessly interact and collaborate cross‑functionally at all levels of the organization.
Drive project goals effectively, efficiently, and proactively, presenting well‑grounded, strategically thought‑through options and arguments to achieve successful regulatory outcomes.
Maintain the highest standards of professionalism, ethics, and regulatory compliance.
Global regulatory strategy
Lead the development and implementation of well‑informed, cutting‑edge strategic regulatory guidance and leadership of assigned projects, in collaboration with the RA sub team / RET and Evidence Team.
Assess and present regulatory risks, options, and opportunities, anticipate challenges, and propose innovative solutions to accelerate development and approval, leveraging the full breadth of regulatory pathways and the most up‑to‑date regulatory science.
Support pivotal moments in the lifecycle of assigned projects in close alignment to Evidence & Asset Teams.
Account for and optimize global regulatory strategy contributions around global business goals, focus country prioritization, and regional requirements.
Anticipate regulatory hurdles and proactively plan strategies to overcome them.
Collaborate closely with stakeholders across the organization to align regulatory strategies with overall business objectives.
Further asset development activities
Collaborate with stakeholders on early target label profile shaping to ensure labeling is aligned with regulatory requirements and business objectives.
In cooperation with Global Labelling, provide global regulatory input into the content of the draft Company Core Datasheet; support RET members in regional/local discussions related to the content of drug labeling during development, submission preparation, submission review, and product lifecycle.
Oversee the planning and execution of regulatory submissions coordinated by the Regulatory Project Manager.
Support submission rollout for Rest of World (RoW) countries from the global strategic perspective.
Registration & lifecycle management
Contribute to and oversee execution of strategies for the lifecycle management of assigned marketed products, including assessing the need for post‑approval changes such as variations, supplements, and line extensions, and developing regulatory plans to implement these changes globally.
Collaborate with Evidence & Asset teams to ensure alignment with business goals and regulatory requirements.
Regulatory intelligence
Stay up to date with and evaluate relevant worldwide regulations and guidelines, evolving regulatory trends and developments, and determine impact on drug development activities and existing strategies, products and submissions.
Proactively communicate the impact of regulatory changes to internal stakeholders and provide recommendations on adapting regulatory strategies.
Develop and advise on contingency plans for assigned projects.
Provide timely risk/benefit analyses of issues affecting products/projects.
Continuously scan the relevant environment for innovative regulatory pathways and perform insightful competitive landscape analysis.
Requirements
Bachelor’s degree in pharmacy, life sciences or chemistry with seven (7) years’ experience in the regulated pharmaceutical industry (biologics or small molecule) required.
Preferred: Master’s Degree or Doctoral Degree (e.g., PhD) in pharmacy, life sciences or chemistry with five (5) years’ experience in the regulated pharmaceutical industry (biologics or small molecule).
Further degrees/certifications: Specialized Pharmacist or Master of Drug Regulatory Affairs, RAC certification.
Technical expertise
In‑depth knowledge of latest regulatory science and global regulatory requirements, guidelines, developments, and standards, allowing for informed comments and input to a broad spectrum of key regulatory documents, challenges, and inflection points.
Demonstrated thorough understanding of the regulatory process and technical competence in core areas of drug development; can analyze and interpret complex scientific data and regulatory guidelines.
Interprets and translates regulatory guidance to project‑specific proposals and proactively provides guidance to the creation of compliant, strategically thoughtful and innovative regulatory solutions to emergent issues.
Commercially aware and has a thorough understanding of the business environment, needs and priorities of the company, the assigned therapeutic area and the contribution of specific assigned development and PMO projects.
Able to work autonomously in a highly efficient manner.
Soft skills
Critical thinker with ability to self‑direct workload, including prioritizing and delivering under tight timelines.
Strong strategic mindset & thinking, with the ability to step out of everyday details and provide a top‑down view.
Adaptability, learning agility and flexibility in navigating changing regulatory environments and adapting strategies accordingly.
Can‑do attitude and a proactive approach to work, demonstrating a willingness to take ownership and find solutions for addressing regulatory challenges and opportunities.
Effective leadership and team management skills.
Strong interpersonal skills, relationship building, sound conflict management skills.
Excellent verbal and written communications skills.
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.
Fluency with necessary computer software (MSWord, Excel, Project, etc.).
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.
Desired Skills, Experience And Abilities Regulatory policy & external stakeholder interactions
Contribute to global strategy and for meetings with health authorities for drug development goals in alignment with Evidence and Asset Team and RET.
Collaborate to define the policy and environment shaping goals, regional‑specific questions and content.
Provide guidance and input to regulatory agency meetings including briefing documentation.
Provide global regulatory input to critical safety or quality communications.
Maintain global oversight of local RA activities in responding to local health authority questions.
Attend and seek out Health Authority meetings for assigned projects.
Stay informed about evolving regulatory expectations, provide input on policy developments, and contribute to shaping regulatory frameworks for better patient outcomes.
External / internal assessments, external partners
Participate and support internal and external pre‑evaluations and contribute to assessment reports.
For projects with a licensing partner, fulfill RA tasks as outlined in the licensing contract.
Proactively drive continuous improvement and increasing efficiencies.
RA sub team leadership
Ensure active involvement in shaping robust strategies aligned with business goals.
Encourage innovative thinking and a proactive approach to anticipate regulatory challenges & opportunities.
Oversee up‑to‑date project information shared by Regulatory Project Manager to ensure sub team members can fulfill their assigned tasks and seek input from RA sub team / RET to accurately reflect global regulatory requirements and challenges in the Evidence Team.
Responsible for the GRA contribution to key project‑related documentation.
Ensure the sub team / RET is appropriately staffed and possesses the necessary skills.
Mentoring
Act as a mentor to foster a collaborative environment where team members can seek feedback and discuss challenges.
Encourage the sharing of experiences and best practices.
Contribute to internal training programs, workshops, and knowledge‑sharing sessions.
Attend relevant conferences, workshops, webinars, and professional development courses such as Advanced Analytics or AI and become a translator on how to use these technologies.
This position offers a base salary typically between $220,000 and $350,000. 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 consult the company benefits website.
Our Company Why Boehringer Ingelheim? With us, you can develop your own path in a company with a culture that knows our differences are our strengths – and break new ground in the drive to make millions of lives better. Here, your development is our priority. We support you to build a career in a workplace that is independent, authentic, and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed. Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after – as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you will be helping to transform lives for generations. Visit https://www.boehringer-ingelheim.com for more information.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Legal
Industries Pharmaceutical Manufacturing
If you want to apply for the position in Germany, please use this link: https://jobs.boehringer-ingelheim.com/job-invite/25587/.
#J-18808-Ljbffr