Associate Specialist, Regulatory Affairs Apac

West Pharmaceutical Services Exton , PA 19341

Posted 2 months ago

Associate Specialist, Regulatory Affairs APAC

Exton

Pennsylvania

West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from concept to patient, West creates products that promote the efficiency, reliability and safety of the world's pharmaceutical drug supply. West is headquartered in Exton, Pennsylvania, and supports its customers from locations in North and South America, Europe, Asia and Australia. West's 2017 sales of $1.6 billion reflect the daily use of approximately 112 million of its components and devices, which are designed to improve the delivery of healthcare to patients around the world.

POSITION SUMMARY:

With a focus on the Asia Pacific region, this role is responsible for coordinating and authoring regulatory submissions for West's products and processes. Address customer regulatory requests and maintain current Asia Pacific and international regulations/guidelines/policies applicable to West's products and services.

PRIMARY DUTIES AND RESPONSIBILITIES:

  • Complete structured regulatory assignments with guidance in support of R&D and commercial programs with a focus on authoring, maintenance and tracking of CMC dossiers [DMFs] for submission to China NMPA in compliance with regulations, guidelines and procedures.

  • Support project development teams and communicate regulatory progress, decisions, strategies, etc., with guidance.

  • Review assigned technical project documentation, certifications, correspondences, and external communications, as needed.

  • Provide support with change controls and customer regulatory requests, including regulatory letters and compliance questionnaires, as needed.

  • Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.

  • Challenge processes, remain open to ideas and changes to continuously improve and seek better alternatives and drive change.

  • Maintain effectiveness when experiencing major changes in work responsibilities or environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.

  • Adhere to all applicable government and West regulations, practices and procedures to maintain compliance.

  • Clearly and effectively communicate team/project progress/status, decisions, timelines, etc.

  • Maintain working knowledge of computer software packages including MS Word, MS Excel, MS Project, MS PowerPoint, Adobe, SharePoint and LOA request system, and others as required.

REQUIRED QUALIFICATIONS:

  • Education: Bachelor's in related discipline (Biology or Chemistry preferred)
  • Experience: 0-3 years of regulatory /pharmaceutical experience

PREFERRED QUALIFICATIONS:

  • Knowledge of CMC regulatory affairs, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance).

  • Demonstrated ability to meet deadlines, manage multiple tasks/projects/priorities and complex systems simultaneously

  • Attention to detail in composing and proofing materials

  • Must work well in a fast pace environment

  • Excellent interpersonal, communication and organizational skills

  • Preferred experience working in a lab or similarly regulated environment

PHYSICAL & TRAVEL REQUIREMENTS:

  • N/A

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 disability or special need that requires accommodation, please send an email to peggy.tayloe@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.


icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Regulatory Affairs Lead (Dir/Sr Dir) Oncology

Idera Pharmaceuticals, Inc.

Posted 4 weeks ago

VIEW JOBS 3/22/2019 12:00:00 AM 2019-06-20T00:00 Overview Idera has an exciting opportunity for a highly collaborative individual to join our team and impact the long-term value of Idera's lead immune-oncology asset, tilsotolimod. The Regulatory Affairs Lead will provide regulatory expertise, direction, and operational oversight of the tilso program, including its ongoing Ph 3 trial in metastatic melanoma and follow on trials in subsequent indications. This role will also collaborate closely and effectively with the cross-functional study/project team in contributing to the development of overall product development strategies for the tilsotolimod program. This position will work from Idera's greater-Philadelphia location in Exton PA. Responsibilities 40% * In alignment with broader program objectives and in partnership with the cross-functional product team, lead the development of effective, compliant, and business-aligned regulatory strategies for the product * Ensure that agreed strategy is appropriately reflected in IND, NDA, sNDA, and other required US and ex-US regulatory filings (e.g., CTA, MAA) and activities * Assess and address impact of regulatory procedures and changes on the program to ensure attainment of goals. 20% * Ensure compliant, timely, and quality implementation of regulatory operations and activities in accordance with agreed strategy and with compliance requirements. * Maintain current knowledge of FDA regulations and guidance regarding INDs, NDAs and electronic submission requirements, as well as familiarity with analogous EMA regulations and guidance. 20% * Develop and maintain collaborative working relationships with pertinent regulatory authorities * Develop strong and positive working relationships with relevant professional organizations, external experts, and opinion leaders * Contribute to high performing cross-functional product and study teams, in accordance with company values. 20% * Identify resource needs and manage vendors as required to support the program * Set and manage to performance expectations and develop team members' skills and capabilities. Qualifications Key Attributes * Highly-motivated, tenacious, and personally accountable self-starter who works with a sense of urgency. * Courage to challenge the status quo and seek new ways to improve work * Highly collaborative and supportive team player, able to positively influence team direction and dynamics * Focus on solving problems rather than assigning blame. * Willingness to share best ideas and thinking, listen to same from others, and support team decisions. * Commitment to quality, excellence, and continuous improvement * Strong direct and indirect people management and development skills * Strong critical, strategic, and analytical thinking Education & Experience Requirements * Bachelor's degree, advanced degree preferred. * Significant experience and growth in drug or device development or other relevant and equivalent experience in the pharmaceutical industry * Proven track record of success in negotiating with regulatory authorities and in representing regulatory interests to internal and external stakeholders * Recent experience in oncology-related filings and regulatory interactions required. * Experience from pre-IND through to NDA filing and commercialization highly desirable. Key Interactions * Internal: CMO, development team members, program leadership, legal * External: FDA / regulatory authorities, vendors, professional scientific and regulatory groups, trade associations, and consultants Other Job Requirements * Occasional travel required. * This is an office-based position Idera Pharmaceuticals, Inc. Exton PA

Associate Specialist, Regulatory Affairs Apac

West Pharmaceutical Services