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Specialist, Regulatory Affairs

2 months ago

Exton, United States West Pharmaceutical Services Full time

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:

The Regulatory Affairs Specialist (RA Specialist) is responsible for supporting registration of West's Administration and Safety System devices, with primary responsibility for obtaining device regulatory approvals/clearances in the APAC regions. This includes the authoring, preparation, and review of technical dossiers. The RA Specialist ensures timely execution in preparation of high-quality deliverables supporting the regulatory submission. In addition, the RA Specialist ensures submissions are compliant with West Pharmaceutical Services, Inc. (West) internal processes and applicable regulatory requirements. This position includes supporting internal and external customer regulatory requests.

Essential Duties and Responsibilities:

  • With management input author and review China, South Korea, Japan and additional international submissions, with guidance for new products and product changes as required to ensure timely approvals/clearance/licensure for market release.
  • Work with global Regulatory Affairs colleagues, Quality Assurance and Research & Development teams to ensure submissions are accurately prepared and comply with global regulations.
  • Provide technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation.
  • Work with RA team to build regulatory strategies, including worldwide requirements lists, for Administration and Safety system device development platforms.
  • Create documentation in response to customer and regulatory agency requests, including regulatory letters, technical packages, etc.
  • Write or update standard operating procedures, work instructions, or policies with guidance.
  • Develop specific objectives and manage work assignments with guidance to achieve personal objectives in conformance with overall business goals.
  • Manage and deliver projects based on priorities.
  • Challenge processes, remain open to ideas and changes to continuously improve, seek better alternatives, and drive change.
  • Adhere to all applicable government regulations and West policies, practices, and procedures to maintain compliance.
Basic Qualifications:
  • Education: Bachelor's, Master's degree or PhD in science, math, engineering, or related discipline
  • Experience: Bachelor's with 2-4 years; Master's degree/PhD 1-2 years medical device regulatory submission experience in the APAC region.
Preferred Knowledge, Skills and Abilities:
  • History of successful international APAC device registration (China, Korea, Japan, etc.)
  • Knowledge of medical device regulations in APAC regions, such as China Decree 739, Korea Medical Device Act, etc.
  • Knowledge of product life cycle, product development process, design controls, and change control.
  • Attention to detail with planning, time management, and organizational skills.
  • Experience interacting with global regulatory agencies.
  • Excellent oral communication, technical writing, and decision-making skills
  • Self-motivated with a proactive attitude and the ability to work effectively.
  • R.A.C certification(s)
  • Experience with Administration and Safety System devices preferred.
  • Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Teams, MS PowerPoint, Master Control, Adobe, SharePoint, and others as required.
Travel Requirements:
  • Must be able to travel up to 5-10% of the time
Physical and Mental Requirements:
  • Ability to work in sedentary environment: exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to life, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally, and all other sedentary criteria are met.
  • 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 literature and documentation, regulations, technical standards, guidance documents, test reports, clinical/medical terminology, technical product information, and complex documents.
  • Ability to review, collate, describe, and summarize scientific and technical data. Ability to organize complex information and combine pieces of information to form general rules or conclusions.
  • Ability to utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one.
  • Ability to assess, plan, schedule and manage multiple long-term and short-term projects, tasks, responsibilities and/or priorities in a concurrent fashion with several parallel deliverables and execute deliverables to time-line commitments.
  • Ability to be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams.
  • Ability to be flexible with changing priorities and comply with constantly changing regulatory procedures.
  • Ability to build strong relationships both internally and externally.
  • Ability to work in a fast-paced environment.
  • Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.
  • Ability to verbally communicate ideas and issues effectively to other team members and management.
  • Ability to write and record data and information as required by procedures.
  • Proficiency in the use of personal computers and computer programs, particularly, Microsoft Office Suite: Excel, Word, PowerPoint, and Adobe Acrobat (or equivalents if changed by the Company).

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West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.