Apeel Sciences Careers
Senior Director, Regulatory Affairs
Apeel Sciences Careers, Santa Barbara, California, us, 93190
About This Role
As the Senior Director of Regulatory Affairs, you will spearhead the development and execution of a dynamic global regulatory strategy for food and biopesticide/biostimulant products, facilitating business growth through gaining market permissibility while ensuring compliance and risk management. Leveraging your extensive expertise, you'll refine regulatory approaches, foster cross-functional collaboration, and provide adept leadership to navigate complex regulatory landscapes. Your role will involve devising clear and compelling strategies to gain market clearance for our products, leading technical and regulatory assessments, mentoring and empowering team members, managing budgets, representing the company in external engagements, and staying abreast of industry trends to proactively address challenges and capitalize on opportunities. This position requires a strategic mindset, deep regulatory and technical knowledge, strong interpersonal skills, and a proven track record in regulatory leadership within heavily regulated industries.
What You'll Do
Develop and lead a comprehensive, proactive, and competitive global regulatory food and biopesticide/biostimulant strategy that unlocks business opportunities, accelerates the achievement of business results, balances risk, and ensures ongoing freedom to operate
Refine regulatory strategies and be accountable for conducting regulatory risk planning and mitigation as new data become available
Collaborate and build strong relationships across technical, commercial, and operations teams (including at executive levels) to gain input and buy-in to the strategy
Represent Regulatory Affairs on cross-functional project teams to resolve complex project issues by providing regulatory expertise and interpretation of regulations (including the navigation of "grey areas") to find the best product development and regulatory registration, approval, and compliance strategies
Develop individual talent and coach others on your team to produce results
Manage the team's budget, optimizing for fixed vs variable in-house and external resources and costs
Represent the company in external-facing communications and build external relationships (e.g., with regulatory agencies, trade associations, customers, etc.)
Develop, communicate, and implement submission planning timelines and metrics and escalate any timeline issues to management
Author, collaborate on, and/or review regulatory submissions and related regulatory documentation or technical data
Stay informed about industry trends, market conditions (including competitive intelligence), and regulatory changes, building these insights into proactive strategies to mitigate risks and capitalize on opportunities
What You'll Bring
Bachelor's degree in a STEM field (Chemistry, Materials Science, Food Science, Nutrition, etc.) required
Advanced degree in a STEM field or Juris Doctor degree in Food Law or related discipline preferred
10+ years of experience working in a heavily regulated environment, preferably in the food, food additives/flavorings, or agricultural inputs industries, with 5+ years of leadership and management experience
Experience working in a regulatory agency is a strong asset
Deep, hands-on experience and proven results developing, implementing, and leading complex global product regulatory strategies and high-performing teams across different product categories and regulatory frameworks, including accelerating the launch of new products and enabling strategic means of advancing and protecting the company’s market position (i.e., horizon scanning)
Intimate understanding of global food and biopesticide/biostimulant regulations and agencies, and vigilant about trends affecting changes to the regulatory landscape
Relentless and creative about problem-solving, complemented with great attention to detail and deep research, technical, and analytical skills, and business acumen
Prudent in judging and managing risk
Proven experience developing and leading a high-performance team
Member of an active, reliable, and robust network of global regulatory contacts and resources to support changing business needs, and a strong, external-facing representative of the organization
Proven results in designing and leading multi-stakeholder advocacy efforts to advance regulatory goals
Collaborative leadership style and strong interpersonal skills, bringing together internal (our commercial, technical, quality, and operational teams) and external partners to achieve shared goals
English proficiency is required
Our total rewards packages may include comprehensive health plans, 401k matching, equity, flexible PTO, sick leave, paid parental leave, and more! Compensation for this role is expected to be between $195,000 and $245,000. Actual base pay may be higher or lower depending on geographic locations, skills, experience, and other factors permitted by law.At Apeel, we value potential and recognize that great candidates come from diverse backgrounds. We seek to build a diverse and inclusive workforce where everyone can thrive. If you are enthusiastic about this role and believe your unique perspective would be an asset to our team, but don't meet every qualification, please don't hesitate to apply!
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As the Senior Director of Regulatory Affairs, you will spearhead the development and execution of a dynamic global regulatory strategy for food and biopesticide/biostimulant products, facilitating business growth through gaining market permissibility while ensuring compliance and risk management. Leveraging your extensive expertise, you'll refine regulatory approaches, foster cross-functional collaboration, and provide adept leadership to navigate complex regulatory landscapes. Your role will involve devising clear and compelling strategies to gain market clearance for our products, leading technical and regulatory assessments, mentoring and empowering team members, managing budgets, representing the company in external engagements, and staying abreast of industry trends to proactively address challenges and capitalize on opportunities. This position requires a strategic mindset, deep regulatory and technical knowledge, strong interpersonal skills, and a proven track record in regulatory leadership within heavily regulated industries.
What You'll Do
Develop and lead a comprehensive, proactive, and competitive global regulatory food and biopesticide/biostimulant strategy that unlocks business opportunities, accelerates the achievement of business results, balances risk, and ensures ongoing freedom to operate
Refine regulatory strategies and be accountable for conducting regulatory risk planning and mitigation as new data become available
Collaborate and build strong relationships across technical, commercial, and operations teams (including at executive levels) to gain input and buy-in to the strategy
Represent Regulatory Affairs on cross-functional project teams to resolve complex project issues by providing regulatory expertise and interpretation of regulations (including the navigation of "grey areas") to find the best product development and regulatory registration, approval, and compliance strategies
Develop individual talent and coach others on your team to produce results
Manage the team's budget, optimizing for fixed vs variable in-house and external resources and costs
Represent the company in external-facing communications and build external relationships (e.g., with regulatory agencies, trade associations, customers, etc.)
Develop, communicate, and implement submission planning timelines and metrics and escalate any timeline issues to management
Author, collaborate on, and/or review regulatory submissions and related regulatory documentation or technical data
Stay informed about industry trends, market conditions (including competitive intelligence), and regulatory changes, building these insights into proactive strategies to mitigate risks and capitalize on opportunities
What You'll Bring
Bachelor's degree in a STEM field (Chemistry, Materials Science, Food Science, Nutrition, etc.) required
Advanced degree in a STEM field or Juris Doctor degree in Food Law or related discipline preferred
10+ years of experience working in a heavily regulated environment, preferably in the food, food additives/flavorings, or agricultural inputs industries, with 5+ years of leadership and management experience
Experience working in a regulatory agency is a strong asset
Deep, hands-on experience and proven results developing, implementing, and leading complex global product regulatory strategies and high-performing teams across different product categories and regulatory frameworks, including accelerating the launch of new products and enabling strategic means of advancing and protecting the company’s market position (i.e., horizon scanning)
Intimate understanding of global food and biopesticide/biostimulant regulations and agencies, and vigilant about trends affecting changes to the regulatory landscape
Relentless and creative about problem-solving, complemented with great attention to detail and deep research, technical, and analytical skills, and business acumen
Prudent in judging and managing risk
Proven experience developing and leading a high-performance team
Member of an active, reliable, and robust network of global regulatory contacts and resources to support changing business needs, and a strong, external-facing representative of the organization
Proven results in designing and leading multi-stakeholder advocacy efforts to advance regulatory goals
Collaborative leadership style and strong interpersonal skills, bringing together internal (our commercial, technical, quality, and operational teams) and external partners to achieve shared goals
English proficiency is required
Our total rewards packages may include comprehensive health plans, 401k matching, equity, flexible PTO, sick leave, paid parental leave, and more! Compensation for this role is expected to be between $195,000 and $245,000. Actual base pay may be higher or lower depending on geographic locations, skills, experience, and other factors permitted by law.At Apeel, we value potential and recognize that great candidates come from diverse backgrounds. We seek to build a diverse and inclusive workforce where everyone can thrive. If you are enthusiastic about this role and believe your unique perspective would be an asset to our team, but don't meet every qualification, please don't hesitate to apply!
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