Ra Intelligence Principal

Requisition ID: 65375- Date: Jun 19, 2024- Location: Exton, Pennsylvania, US- Department: Regulatory Affairs- Description:
At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

**Job Summary**:
**Essential Duties and Responsibilities**:

- Perform surveillance activities by researching, identifying, and communicating up to date global chemical and material regulatory requirements that facilitate development, registration, submission and post marketing of West’s products and services. Surveillance areas include, but are not limited to, chemicals, devices, pharmaceuticals, combination products, labeling, and packaging.
- Research and articulate the latest regulatory intelligence to internal stakeholders and contextualize the impact on West portfolio and business. Ensure that changes to applicable regulations are clearly and effectively communicated to drive action.
- Develop intelligence of emerging regulatory trends and communicate implications to internal stakeholders and external customers through updates to relevant portions of Master Regulatory Plan(s), trainings, presentations, white papers, etc.
- Monitor, analyze, and recommend action plans for current and future industry initiatives and draft public comments in response to regulations and guidance issued by regulators and health authorities.
- Collaborate with R&D, Quality Assurance, Clinical Affairs, and other departments to ensure alignment with regulatory requirements including but not limited to participating in project teams to provide regulatory guidance throughout the product lifecycle.
- Collaborate with and lead discussions with consultants and external vendors to assist in global regulatory strategies. Participate in industry events, conferences, or working groups, as applicable.
- Manage relationships, including subscriptions, with regulatory vendors, ensuring timely delivery of documentation and materials.
- Provide training to internal teams on regulatory requirements and updates related to pharmaceutical, packaging, medical devices and combination products.
- Maintain a high level of regulatory awareness through building influence through engagement in relevant trade associations, coalitions, and alliances.
- Other duties as assigned.

**Basic Qualifications**:

- Education: Bachelor’s, Master’s degree or PhD in science, math, engineering or related discipline
- Experience: Minimum 8 years.
- Able to work collaboratively across all levels of the organization to influence and persuade others.
- Experience directly interacting and presenting to project teams, customers, industry groups
- Demonstrated understanding of related medical device development and operations (e.g., manufacturing, process development, analytical, quality assurance).
- Strong negotiation and decision-making skills.
- Excellent written and verbal communication, timeline management and leadership skill
- Self-motivated with a proactive attitude and the ability to work effectively.
- Ability to work collaboratively in a cross-functional team environment.
- Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.

**Preferred Knowledge, Skills and Abilities**:

- Regulatory compliance competency including ISO 13485 certified Quality Systems
- International regulatory competency
- Advanced degree
- Regulatory Affairs Certification (R.A.C)
- Experience with pharmaceuticals, administration and drug delivery systems preferred

**Travel Requirements**:

- Must be able to travel up to 5 - 10 % of the time (meeting, trainings, projects, industry events)

**Physical & Mental Requirements**:
Ability to comprehend principles of math, science, engineering, and medical device use. Ability to handle technical reports, drawings, specifications, regulatory and quality documentation with a high degree of confidentiality. Ability to research, read, analyze, and interpret regulatory literatur