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Boehringer Ingelheim · 1 day ago

Director, Global Regulatory Strategy Lead

Ridgefield, CT

Full-time

Hybrid

Director/Executive

$220K/yr - $350K/yr

7+ years exp

Boehringer Ingelheim is a global leader in the pharmaceutical industry, and they are seeking a Director, Global Regulatory Strategy Lead to provide strategic regulatory guidance throughout the product lifecycle. The role involves developing regulatory strategies, leading the Regulatory Excellence Team, and ensuring compliance with global regulatory standards while collaborating with various stakeholders.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

Effectively lead with in-depth expertise in at least one TA 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

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 the development and approval process, leveraging the full breadth of regulatory pathways and 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 contribution 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

Collaborate with stakeholders on early target label profile shaping, to ensure labelling is aligned with reg, requirements & business objectives

In cooperation with Global Labelling, provide global regulatory input into content of the draft Company Core Datasheet; support RET members in regional/local discussions related to the content of drug labelling 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

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

Stay up to date with and evaluate relevant worldwide regulations and guidelines, evolving regulatory trends and developments, impact on drug development activities and determine impact on existing strategies, products and submissions

Proactively communicate the impact of regulatory changes to internal stakeholders and provide recommendations on adapting regulatory strategies

Develop and advises 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

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

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

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

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, e.g., Advanced Analytics or AI and becoming a translator on how to use these technologies

Qualification

Global regulatory strategyRegulatory complianceRegulatory risk assessmentDrug development expertisePharmacy degreeRegulatory Affairs certificationAnalytical skillsLeadership skillsCommunication skillsTeam managementOrganizational skillsAdaptability

Required

Bachelor's degree in pharmacy, life sciences or chemistry with seven (7) years' experience in regulated pharmaceutical industry (biologics or small molecule)

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 infliction points

Demonstrated thorough understanding of the regulatory process and technical competence in core areas of drug development and 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 thought-through 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 TA and the contribution of specific assigned development and PMO projects

Able to work autonomously in a highly efficient manner

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 environment and adapt 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.)

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

Master's Degree or Doctoral Degree (e.g., PhD) in pharmacy, life sciences or chemistry with five (5) years' experience in regulated pharmaceutical industry (biologics or small molecule)

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

Benefits

Role specific variable or performance based bonus

Other compensation elements

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