Senior Legal Counsel - Regulatory

Description Overview

This is an exciting opportunity to apply your legal expertise to be a trusted legal business partner to our Consumer Self Care Americas (CSCA) team. As Senior Legal Counsel Regulatory, you will play a crucial role in ensuring compliance with applicable laws, regulations, and guidelines governing the consumer self-care and over-the-counter (OTC) self-care industry. The ideal candidate will have a strong regulatory background, with a focus on the Food and Drug Administration (FDA) regulations within the Consumer Self Care, pharmaceutical and/or Active Pharmaceutical Ingredient (API) industry. In this pivotal role, you will have the opportunity to work closely with the business to assist the company in obtaining FDA clearance and approval to market products and in marketing and selling such products in compliance with these regulations.

The candidate selected to fill this role will work in person at our North American Headquarters in Grand Rapids, Michigan.

Scope of the Role

• Regulatory
  • FDA Compliance: Lead and oversee efforts to ensure the company's compliance with FDA regulations, guidelines, and policies related to the development, approval, and marketing of Consumer Self Care, pharmaceutical and/or Active Pharmaceutical Ingredient (API) products.
  • Regulatory Strategy: Develop and implement regulatory strategies to support product development, approval, Rx-to-OTC Switch, and post-marketing activities. Stay abreast of changes in regulations and assess their impact on the company's operations.
  • Legal Analysis: Conduct legal analysis of FDA regulations and provide timely and strategic advice to internal stakeholders on regulatory matters. Collaborate with cross-functional teams to address legal and regulatory challenges.
  • Regulatory Submissions: Oversee the preparation, review, and submission of regulatory documents to the FDA, ensuring accuracy and adherence to regulatory requirements.
  • Risk Management: Identify potential regulatory risks and work proactively to develop mitigation strategies. Provide guidance on risk assessment and management in the context of FDA compliance.
  • Collaboration: Collaborate with internal teams, including R&D, Quality Assurance, and Marketing, to align regulatory strategies with business objectives. Liaise with external legal and regulatory experts as needed.
  • Training and Education: Provide training and education to internal stakeholders on relevant regulatory matters, ensuring a strong understanding of compliance requirements.
  • Advocacy: Represent the company in interactions with regulatory authorities, industry associations, and other relevant forums.
• Commercial
  • Advice: Providing expert legal advice and counsel to the organization's management team, executives, and other stakeholders. This includes assisting with legal issues related to business operations, contracts, regulatory compliance, and risk management.
  • Contract drafting and negotiation: Reviewing, drafting, and negotiating a wide range of contracts, including commercial agreements and licensing agreements. Ensuring that the organization's interests are protected and that contracts comply with applicable laws and regulations.
  • Business Development: provide leadership, strategic and tactical regulatory support for all product development and category expansion, including Rx-to-OTC Switch programs.

Experience Required

• • Juris Doctor (J.D.) degree from an accredited law school required
  • Admission to practice law in Michigan (North American Headquarters)
  • 7-10+ years of legal experience, preferably with a combination of in-house and law firm experience
  • The ideal candidate will possess extensive expertise in regulatory affairs, particularly with a focus on the Food and Drug Administration (FDA) regulations within the Consumer Self Care, prescription and/or Active Pharmaceutical Ingredient (API) industry
  • In-depth knowledge of FDA regulatory requirements for drug development, approval, and post-marketing activities; proven experience in Rx-to-OTC switches is a plus
  • Strong strategic thinking and business acumen, with the ability to balance legal considerations with business objectives
  • Strong legal research, analysis, and written/verbal communication skills
  • Proven experience in leading regulatory compliance efforts
  • Excellent interpersonal and collaboration skills
  • 10% travel required