Regulatory Affairs Manager

3 weeks ago

Santa Ana, United States McGuff Family of Companies Full time

**The McGuff Company Inc. is growing and looking to hire a Regulatory Affairs Manager**

McGuff values its employees as one of its most important resources. We strive for a vibrant, healthy work culture and attain it through good communication, active involvement, and corporate responsibility. We leverage our employees’ expertise and support their professional development for mutual growth.

**About McGuff**

McGuff was established in 1972 and has remained family and veteran owned. The McGuff family of companies consists of three unique entities: McGuff Company, Inc. (MCI) - medical products distribution; McGuff Pharmaceuticals (MPI) - drug manufacturing; and McGuff Outsourcing Solutions (MOS) - compounded drug manufacturing. All McGuff companies are registered with the Food and Drug Administration and adhere to strict quality standards.

We are committed to providing our customers with high-quality, fairly priced products, fast delivery, and excellent customer service. All employees at McGuff take pride in our work and work hard to maintain our valued reputation amongst our customers worldwide.

**Position Overview**

We are seeking a dynamic and skilled professional to join our team and oversee the regulatory affairs department.

To be successful in this role, you should have at least ten years of experience in the pharmaceutical industry or a related field. You should also have knowledge of FDA cGMP requirements, ISO standards, ICH guidelines, and quality management systems. You should have excellent communication, grammar, spelling, and problem-solving skills, and be able to work independently or as part of a team.

This is a full-time position based in Santa Ana/Costa Mesa, California.

The role of a **Regulatory Affairs Manager** is crucial in ensuring that our products comply with regulations and laws governing their manufacturing, sale, and distribution. We specialize in New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), International drug approvals, and 503B outsourcing of non-approved drugs, here are the key responsibilities, experience requirements, and other important aspects for this position:
**Duties and Responsibilities**:

- **Liaison with Regulatory Agencies**: The regulatory affairs manager serves as the primary point of contact for communication and interaction with regulatory agencies (such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA)). They represent the company in regulatory meetings, discussions, and negotiations, and provide responses to regulatory inquiries and requests for information.
- **Cross-Functional Collaboration**: The regulatory affairs manager collaborates with cross-functional teams within the organization (including research and development, quality assurance, manufacturing, marketing, and legal departments) to ensure alignment and coordination on regulatory matters.
- **Leadership**: This position requires the regulatory affairs manager to exhibit empathy, self-awareness, social skills, understand team dynamics, manage conflicts, and foster a positive work environment by encouraging collaboration, promote trust, and empower team members to excel.

**Experience Required**:

- **At least 10 years of experience** in pharmaceutical regulatory affairs. Regulatory experience in aseptic manufacturing is beneficial.
- **Knowledge of regulatory processes and requirements** in different regions or countries.
- **Experience in preparing and submitting regulatory submissions**.
- **Understanding of clinical trial regulations and processes** (if applicable to the industry).

**Other Important Requirements**:

- **Master’s degree** in a related field (such as pharmaceuticals, healthcare, biomedical engineering, chemistry).
- **Strong communication and interpersonal skills**.
- **Knowledge of relevant pharmaceutical laws and regulations**.
- **Proficiency in data analysis**.
- **Business Acumen and willingness to be an advocate for or the organization’s interests while respecting regulatory boundaries.**

In summary, a successful regulatory affairs manager combines technical expertise with leadership skills to maintain excellence, foster growth, and ensure compliance within their department and the broader organization.

McGuff Pharmaceuticals, Inc. offers a competitive salary, advancement opportunities, and a comprehensive benefits package.

Enjoy excellent working conditions. Semi-flexible hours, full-time day shift, Monday to Friday. Santa Ana/Costa Mesa area.

Pay: $125,000.00 - $225,000.00 per year

**Benefits**:

- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance

Schedule:

- 8 hour shift
- Monday to Friday

**Education**:

- Master's (preferred)

Work Location: In person

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