You oversee global regulatory strategies for Mental Health and Eye Health projects, guiding compliance efforts and fostering team excellence while ensuring that regulatory considerations align with business objectives.
Anforderungen
- •High level of education in pharmacy
- •Master's or Doctoral Degree preferred
- •Specialized Pharmacist certification desirable
- •Master of Drug Regulatory Affairs certification desirable
- •RAC certification desirable
- •In-depth knowledge of Regulatory Affairs
- •Proven track record in regulatory strategies
- •Experience with IND, (s)BLA/(s)NDA preparation
- •Experience with MAA and Health Authority meetings
- •Negotiation experience with Health Authorities
- •Regulatory experience in Mental Health preferred
- •Regulatory experience in Eye Health preferred
- •R&D experience considered an asset
- •Experience in COA strategy development beneficial
- •Proven ability to interpret scientific data
- •Strong critical thinking and strategic mindset
- •Excellent leadership and team management skills
- •Strong interpersonal and relationship-building skills
Deine Aufgaben
- •Contribute to global strategy for Mental Health and Eye Health projects.
- •Lead development of strategic regulatory strategies.
- •Assess regulatory risks and propose innovative solutions.
- •Collaborate with stakeholders to align regulatory strategies.
- •Ensure timely incorporation of regulatory considerations in decision-making.
- •Lead the Regulatory Excellence Team and foster a culture of learning.
- •Mentor team members and identify training needs.
- •Oversee planning and execution of regulatory submissions.
- •Support submission rollout for Rest of World countries.
- •Stay updated on worldwide regulations and guidelines.
- •Evaluate regulatory trends and conduct risk/benefit analyses.
- •Develop contingency plans for assigned projects.
Original Beschreibung
# Global Regulatory Strategy Lead
## The Position
We are seeking a dynamic individual to provide global strategic regulatory guidance and leadership throughout the product lifecycle on assigned projects in the Therapeutic Area of Mental Health, Eye Health & Emerging Areas. In this pivotal role, you will develop and be accountable for the Global Regulatory Strategy of your projects lead the Regulatory Excellence Team (RET), and represent Global Regulatory Affairs (GRA) on the Evidence Team (aka the cross-functional project Team).
This position can be filled in Germany (Ingelheim) or the US.
## Tasks & responsibilities
* As a regulatory professional, you will contribute to a holistic global strategy for assigned Mental Health, Eye Health & Emerging Areas projects. Your leadership and in-depth expertise will enable you to interact seamlessly at all levels of the organization, drive project goals, and maintain the highest standards of professionalism, ethics, and regulatory compliance.
* You will lead the development and implementation of cutting-edge global strategic regulatory strategies. Your role will involve assessing regulatory risks, proposing innovative solutions, and collaborating closely with stakeholders to align regulatory strategies with business objectives.
* As the main GRA representative on the Evidence Team, you will ensure that regulatory considerations are incorporated timely and comprehensively in the decision-making process.
* You will lead the Regulatory Excellence Team (RET) for assigned projects, fostering a culture of excellence and continuous learning. Your role will involve mentoring team members, identifying training needs, and promoting a proactive and solution-oriented approach.
* In collaboration with Asset & Evidence teams and Global Labelling, you will shape early target label profiles and oversee the planning, preparation, and execution of regulatory submissions. Your role will also involve supporting submission rollout for Rest of World (RoW) countries from a global strategic perspective.
* As a regulatory intelligence expert, you will stay up-to-date with relevant worldwide regulations and guidelines. Your role will involve evaluating evolving regulatory trends, providing timely risk/benefit analyses, and developing contingency plans for assigned projects.
## Requirements
* High level of education in pharmacy, life sciences, or chemistry, ideally holding a Master's or Doctoral Degree. Additional certifications such as Specialized Pharmacist, Master of Drug Regulatory Affairs, or RAC are highly desirable.
* In-depth knowledge of Regulatory Affairs across multiple regions, including the US and/or EU. You have a proven track record of developing and implementing successful regulatory strategies, ideally with preparation of IND, (s)BLA/(s)NDA and/or MAA, Health Authority meeting briefing documents and negotiating with Health Authority(ies) in a major market (e.g. US, EU).
* Regulatory experience in Mental Health and/or Eye Health diseases is preferred, and experience outside of Regulatory Affairs in R&D will be considered a valuable asset.
* Experience in COA strategy development including COA dossiers will be considered beneficial.
* Proven ability to interpret and translate complex scientific data and regulatory guidelines into project-specific proposals. You should have a commercial awareness and a thorough understanding of the business environment.
* Strong critical thinking and strategic mindset, with the ability to anticipate both opportunities and challenges in execution. You should excel at problem-solving, decision-making, and developing realistic action plans to achieve specific goals.
* Excellent leadership and team management skills, with the ability to influence, lead, and inspire cross-functional teams. You should have strong interpersonal skills, relationship building, and conflict management skills.