Senior Legal Counsel - Regulatory

7-10 yrs required

Full-time

No

Job Segment: Law, Pharmaceutical, Compliance, Legal, Science, Research, Healthcare

The company is seeking a Senior Legal Counsel - Regulatory to join their team in Grand Rapids, MI. This is a full-time position with a competitive salary and benefits package.

The Senior Legal Counsel - Regulatory will be responsible for ensuring compliance with applicable laws, regulations, and guidelines governing the consumer self-care and over-the-counter (OTC) self-care industry. They will also play a crucial role in supporting product development, approval, and marketing activities in compliance with FDA regulations.

The ideal candidate will have a strong regulatory background, with a focus on FDA regulations within the Consumer Self Care, pharmaceutical, and/or Active Pharmaceutical Ingredient (API) industry. They should possess a Juris Doctor (.) degree from an accredited law school and be admitted to practice law in Michigan. Additionally, 7-10+ years of legal experience, preferably with a combination of in-house and law firm experience is required.

This is an exciting opportunity to work closely with the business to assist in obtaining FDA clearance and approval to market products. The Senior Legal Counsel - Regulatory will also provide expert legal advice and counsel to the organization's management team and executives, and collaborate with cross-functional teams to address legal and regulatory challenges.

The company is an equal opportunity employer and offers a full Equal Employment Opportunity and Affirmative Action Policy Statement. They are committed to providing a diverse and inclusive workplace for all employees.

Key Responsibilities:

- Lead and oversee efforts to ensure 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
- Develop and implement regulatory strategies to support product development, approval, Rx-to-OTC Switch, and post-marketing activities
- Conduct legal analysis of FDA regulations and provide timely and strategic advice to internal stakeholders on regulatory matters
- Oversee the preparation, review, and submission of regulatory documents to the FDA
- Identify potential regulatory risks and work proactively to develop mitigation strategies
- Collaborate with internal teams to align regulatory strategies with business objectives
- Provide training and education to internal stakeholders on relevant regulatory matters
- Represent the company in interactions with regulatory authorities and industry associations
- Provide expert legal advice and counsel to the organization's management team, executives, and other stakeholders
- Review, draft, and negotiate a wide range of contracts, ensuring compliance with applicable laws and regulations
- Provide leadership, strategic and tactical regulatory support for all product development and category expansion, including Rx-to-OTC Switch programs

Requirements:

- Juris Doctor (.) 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
- Extensive expertise in regulatory affairs, particularly with a focus on 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; experience with Rx-to-OTC switches is a plus
- Strong strategic thinking and business acumen
- Excellent legal research, analysis, and written/verbal communication skills
- Proven experience in leading regulatory compliance efforts
- Excellent interpersonal and collaboration skills
- 10% travel required

Equal Employment Opportunity and Affirmative Action Policy Statement:

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. Our full Equal Employment Opportunity and Affirmative Action Policy Statement is available on our main career site in English and Spanish and will be provided in other accessible forms for persons with disabilities.

Apply now to join the team and make a difference in the lives of consumers by bringing quality, affordable self-care products to the market.

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Legal expertise, strategic thinking, business acumen, legal research, analysis, written and verbal communication, leadership, collaboration, regulatory compliance, risk assessment and management, training and education, advocacy, contract drafting and negotiation, FDA regulatory requirements, legal advice and counsel, business development.

Juris Doctor (J.D.) degree from an accredited law school

To apply to this position, please click the APPLY button at the bottom of the application.

Qualification and Experience Juris Doctor (J.D.) degree from an accredited law school, Admission to practice law in Michigan, 7-10+ years of legal experience, extensive expertise in regulatory affairs, in-depth knowledge of FDA regulations, strong strategic thinking and business acumen.

Legal