Title:  Sr Regulatory Project Manager

ONSITE POSITION AT EXTON,PA  

Position is hybrid in nature however candidate applying must be within a 50 mile radius of the following plant locations:-  Exton PA, Jersey Shore PA, Williamsport PA, Clearwater FL, St Petersburg FL, Kinston NC, Kearney NE, Upper Darby PA, Phoenix AZ, Tempe AZ, Rockford AZ, Scottsdale AZ, Grand Rapids MI, Radnor PA.

Who We Are:

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

Job Summary:

The Senior Specialist, Regulatory Project Manager (RPM) is primarily responsible for management of Regulatory Affairs projects associated with West's global portfolio of packaging components, medical devices and combination products. This role will work collaboratively with cross-functional teams and lead the regulatory team through all project phases to support regulatory filings, including Pre-Market Notifications, Technical Documentations under EU MDR and Master Files (DMF/MAF) associated with a pharmaceutical partner's NDAs, ANDAs and BLAs. Requrements include maintaining knowledge of current international regulations/guidelines/policies applicable to West's products and services. This position includes providing regulatory guidance and updates to internal and external stakeholders in line with defined regulatory plans. This position can accommodate a remote work location.

Essential Duties and Responsibilities:

• With minimal guidance, manage complex regulatory project lifecycle(s) including pre-submission, submission, post-submission, and post-approval maintenance cycles
• Provide project management inputs on immediate and long-term global regulatory strategies
• Collaborate with cross-functional project manager(s) and SMEs to align on essential deliverables required for global submissions
• Lead internal and external discussions related to filing strategy for combination product applications
• Manage and allocate resources as needed to support regulatory activities while maintain timelines
• Develop and manage regulatory action plans to achieve on time regulatory submissions and information request response
• Provide project management oversight, form mitigation plans for submission risks, and escalate issues as needed
• Use data-driven decision-making processes to develop and adjust regulatory action plan for continuation, acceleration, and reprioritization
• Manage post approval submission amendments and annual reporting for regulatory compliance
• Challenge current processes and develop systems to continuously improve and drive change

Basic Qualifications:

• Education: Bachelor's degree in related discipline
• Experience: Bachelor’s degree with 3-5 years; Master’s degree/PhD with 2-3 years
• Strong project management skill and extensive project management experience in pharmaceutical or medical device field
• Proven ability to lead complex projects in a cross functional team environment
• Experience in managing resource requirements
• Knowledge of regulations and standards related to combination product and medical device design control process
• Excellent interpersonal, communication and organizational skills with a proven record of working with and influencing multi-disciplinary teams and external experts
• Possesses technical skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance). 
• Excellent written and verbal communication, organizational, timeline management and leadership skill
• Experience utilizing Microsoft Office products such as MS Project and Excel
• Self-motivated with a proactive attitude and the ability to work effectively

Preferred Knowledge, Skills and Abilities:

• Working knowledge of medical device regulatory affairs, design control process, and management of regulatory support systems is a plus
• Experience in global regulatory submissions of Class I and II medical devices
• Experience building detailed submission plans and analyzing technical requirements
• Excellent interpersonal, communication and organizational skills with a proven record of working with and influencing multi-disciplinary teams and external experts
• Advanced degree 
• R.A.C certification(s)

Travel Requirements:

• Must be able to travel up to 5% of the time

Physical & Mental Requirements:

• The following abilities are expected for this position
  • Comprehend principles of math, science, engineering, and medical device use
  • Handle technical reports, drawings, specifications, proprietary documentation with a high degree of confidentiality.
  • 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.
  • Review, collate, describe, and summarize scientific and technical data.
  • Organize complex information and combine pieces of information to form general rules or conclusions. 
  • Utilize judgment and make decisions considering the relative risks and benefits of potential actions to choose the most appropriate one.
  • 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.
  • Be an effective team member and work well with others in a team environment on cross-functional and/or matrix teams.
  • Be flexible with changing priorities and comply with constantly changing regulatory procedures. Ability to build strong relationships both internally and externally.
  • Work independently in a fast-paced environment.
  • 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.

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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.