• Develop regulatory strategy including CMC, non-clinical, and clinical trial strategies as well as marketing authorization applications.
• Represent Regulatory Affairs for the assigned portfolio at management and external stakeholder levels.
• Oversee all Regulatory Affairs programs and projects, and guide teams to ensure cross-functional integration, coordination, and alignment.
• Provide leadership guidance and direction in ongoing enhancements/development of core and sub-team processes, structures, systems, tools, and other resources.
• Ensure compliance with regulations, guidelines, and ICH by the Health Care Agencies in Europe (EMA) the US (FDA), and potentially additional regions.
• Prepare and review clinical trial applications (CTA) to both Ethics Committees and Competent Authorities.
• Gather, evaluate, organize, manage, and collate information in a variety of formats, including trial data.
• Plan, undertook, and oversaw product trials and regulatory inspections.
• Keep up to date with changes in regulatory legislation and guidelines.
• Offer advice about company policies, practices, and systems.
• Outline requirements for labeling, storage, and packaging.
• Liaise and negotiate with regulatory authorities.
• Provide advice about regulations to manufacturers and scientists.
• Prepare regulatory filings for marketing authorizations.
• Write comprehensible, user-friendly, clear product information leaflets and labels.

Skills: Regulatory Strategy, Stakeholder Management, Team Leadership, Process Improvement, Compliance, Trial Applications, Inspections, Filings and Labeling

• Develop and implement regulatory strategies including identifying optimal regulatory routes and identifying and assessing regulatory risks
• Provide regulatory guidance to other functional teams
• Review protocols and study reports
• Work with functional teams on their contributions to regulatory documents
• Lead the preparation and submission of regulatory filings
• Oversee the progress of regulatory filings and the writing of regulatory briefing documents
• Maintain effective communications with regulatory agencies
• Coordinating with outside regulatory consultants and vendors
• Develop, maintain, and improve document management systems to support regulatory activities
• Train and mentor regulatory affairs support personnel.
• Plan and oversee department budget.
• Monitor regulatory guidelines and trends related to CMC

Skills: Regulatory Strategy, Cross-functional Guidance, Document Review, Filing Coordination, Agency Communication, Vendor Coordination, Document Management, Budget Planning

• Contribute, develop, and implement global regulatory strategies including scenarios for the earliest regulatory approvals possible as well as an assessment of risk for each of the various scenarios
• Identify, monitor, and resolve regulatory issues and report progress.
• Lead regulatory submission activities and review regulatory documents before submission to ensure overall quality, compliance, and timeliness with minimal supervision.
• Coordinate cross-functional teams in the R&D organization to review and approve submission document deliverables and ensure the submission documents are of high quality.
• Collect and analyze regulatory intelligence for assigned projects and communicate assessments with advice on regulatory significance and options.
• Lead/support Health Authority interactions including briefing document preparation, coordination of meetings, preparations with subject matter experts, and documentation and archiving of minutes.
• Liaise and negotiate with global regulatory authorities for all aspects of drug development including resolution of key regulatory issues.
• Ensure that quality standards are met, and submissions meet strict deadlines.
• Prepare any relevant documentation, and develop and author SOPs.
• Stays abreast of new regulatory developments and opportunities in EPA, FDA, AAFCO, DOT, Canada, Mexico, and the EU.
• Monitor regulatory activities of competitors and communicate those activities to management.
• Maintain familiarity with company products.
• Participate in product development teams
• Evaluate device aspects according to the regulatory impact.

Skills: Regulatory Strategy, Issue Resolution, Submission Leadership, Cross-functional Coordination, Intelligence Analysis, Health Authority Interaction, Regulatory Liaison, SOP Development

• Lead a global Regulatory Operations function, including management of publishing vendors and contractors involved in supporting RIM implementation.
• Define and execute strategies for Regulatory Information Management and Archiving systems, applications, and submissions for INDs/CTAs/BLAs/MAAs and required maintenance across products in the US.
• Coordinate with Regulatory Medical Writing, IT, and other functional areas to accomplish Regulatory Operations objectives.
• Serve as representative to Regulatory Agencies on technical aspects of eCTD/NeeS filings.
• Manage customization of INDs/IMPDs, BLAs/MAAs, SPL, and briefing dossiers, provide document formatting support, and organize submissions in a professional, compliant, high-quality, and timely manner.
• Provide leadership for all Regulatory Operations matters on the global Regulatory Affairs team.
• Direct the development and training on Regulatory Operations and publishing SOPs and best practices, direct inspection readiness activities
• Maintain expert knowledge of regional regulatory publishing requirements and precedents that may affect company filings.
• Responsible for the development and implementation of systems and process improvements to support greater efficiency in regulatory operations.
• Maintain a world-class regulatory operation system and standards including publishing and archiving.
• Interface regularly with Regulatory leads to maintain an overview of upcoming submissions for all products and prioritize between the different projects.
• Accountable for the overall planning and management of Regulatory resources to support global submissions (IND, NDA, CTA, MAA, drug listing, and maintenance activities).

Skills: Regulatory Leadership, Vendor Management, Information Management, Cross-functional Coordination, eCTD Filing, Document Customization, SOP Development, Process Improvement

• Utilize expertise and knowledge of regulatory requirements to strategically interpret, plan, and communicate requirements to ensure RA goals and objectives are met.
• Oversee the Regulatory Affairs function and compilation of device regulatory filings/submissions including 510(k), PMA, IDE, Design Dossiers, and other correspondences to US and international regulatory agencies to obtain product marketing clearance.
• Apply regulations, standards, and guidance documents during the development of domestic and international regulatory documentation.
• Defines regulatory processes and best practices to ensure consistent implementation.
• Maintain up-to-date knowledge of the data, information, and formats required for inclusion in submission applications.
• Work with the Marketing functional group to develop regulatory strategies for new product registration projects including planning, facilitating requests, and monitoring the progress, status, and timelines to accomplish project deliverables.
• Provide feedback to project team members in a risk-based least burdensome approach to achieve essential requirements and regulatory deliverables.
• Provide input for product labeling including promotional material/literature and other potential labeling changes to sustaining products to ensure no regulatory issues exist
• Communicate results to management, cross-functional teams, notified bodies, distributors, and other functions as appropriate.
• Drive and maximize the use of the regulatory documentation systems/databases to improve departmental efficiencies.
• Manage regulatory interactions with local country distributors and serve as a point of contact
• Support local regulatory representatives in clarifying regulatory questions and providing input to help expedite responses to regulatory authorities.
• Oversee and maintain regulatory filings such as design dossiers, technical files, establishment registrations, device listings, certificates to Foreign Governments, etc.
• Adhere to strategic goals and objectives.
• Supervise, and provide mentoring, coaching, and training to regulatory staff to strengthen and deepen RA talent.

Skills: Regulatory Strategy, Device Regulatory Filings, Regulatory Documentation, Process Definition, Submission Knowledge, Cross-functional Collaboration, Risk-based Approach, Regulatory Systems Management

• Experience inclusive of postgraduate education and/or pharmaceutical or healthcare industry experience or equivalent
• Experience developing or contributing to global regulatory strategies while working in regulatory affairs or related functions (i.e., RandD, quality, reg compliance)
• Experience in biologics and knowledge of FDA regulations.
• Experience directly writing submission documents that support clinical trials, marketing applications, and lifecycle management
• Experience with regulations or product development in gene therapy, such as CAR-Ts, AAVs, or CRISPR technology, etc.
• Good understanding of regulatory precedent in the area and requirements for early/late development
• Solid understanding of biology, chemistry, and/or engineering relevant to the pharmaceutical industry
• Experience leading interactions with Health Authorities
• An understanding of health authority laws, regulations, guidance, and regulation submission routes available for assigned products 
• Excellent verbal and written communication and presentation skills
• Experience with imaging or high-risk devices
• Strong experience with management of regulatory projects in global regulatory organizations and working globally and across different cultures

Qualifications: BS in Pharmaceutical Sciences with 9 years of Experience

• Speaks clearly and persuasively in positive or negative situations
• Demonstrates group presentation skills and conducts productive meetings.
• Observe safety and security procedures and use equipment and materials properly.
• Ability to look for ways to improve and promote quality and demonstrate accuracy and thoroughness.
• Can identify and resolve problems promptly and gather and analyze information skillfully.
• Prioritizes and plans work activities, uses time efficiently, and develops realistic action plans.
• Synthesizes complex or diverse information.
• Displays willingness to make decisions exhibits sound and accurate judgment, and makes timely decisions.
• Demonstrates a willingness to organize and explain complex regulatory or compliance concepts.
• Has made the growth and development of others a priority.
• Observed to share information positively, accurately, and effectively with others.
• Effective communicator both written and verbal to project team members, cross-functionally, to regulatory consultants and clients.
• Has a history of helping diverse groups accomplish goals positively.
• Excellent technical, written, and verbal communication skills
• Excellent interpersonal skills, and strong computer skills, including Microsoft Office.

Qualifications: BS in Clinical Research with 11 years of Experience

• Knowledge of West elastomer product portfolio
• Previous work in a fee-for-service organization
• Managerial experience with a demonstrated track record of successfully managing high-performance cross-functional matrix teams in a complex organization
• Strong RA and QA background for IVD medical devices.
• Knowledge of global regulatory standards required (EU, China, US) and international registration processes.
• Extensive experience implementing, interpreting, and providing guidance on domestic and international regulations for medical devices/ IVD.
• Comfortable with technical data, and effectively present and respond to questions on global requirements and practices.
• Development of the members of the team to effectively execute the RA/QA activities.
• Ability to communicate and work with leaders across business units
• Writing skills needed for policy updates and process updates
• Ability to facilitate training extending from sales teams to executive teams
• Fluent in English and Chinese/Mandarin (written and communication)

Qualifications: BS in Public Health with 13 years of Experience

• Experience in a similar role in the medical device industry.
• In-depth knowledge of FDA regulatory pathways (510(k), de novo), CFR 21 Part 820, ISO 13485, and MDR as well as a sound understanding of product development including clinical trials/GCP and how they affect the regulatory approval timeline in different territories
• Direct experience with the US regulator e.g. pre-submission meetings, lead on 510(k), IDE or PMA submission/deficiency responses
• Experience with software as a medical device (SaMD) including firmware, apps, and cloud-based algorithms is a strong plus
• Excellent communication, people, and project management skills to lead the “approval journeys”
• Ability to work independently in a fast-paced environment and to manage multiple, competing priorities
• Comfortable dealing with high-pressure and regulatory uncertainties
• Fluency in English, and other European languages 
• Professional experience in Regulatory Affairs, Healthcare, or Pharma-related areas.
• Diversified leadership, planning, communication, organization, and people motivation skills (or equivalent experience).
• Knowledgeable of regulatory affairs, compliance, and due diligence
• Executive-level writing skills
• Ability to handle multiple tasks and challenges simultaneously.

Qualifications: BS in Pharmacy with 12 years of Experience

• Extensive knowledge of clinical research and product development life cycles for investigational and marketed healthcare products.
• Extensive working knowledge of activities related to regulatory affairs, reimbursement, and quality assurance, both domestic and international.
• Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff, and with the public.
• Ability to be detail-oriented with a background adequate to deal with scientific issues related to technical regulations and SOPs.
• Ability to read and synthesize technical material and to prepare clear and concise written documents.
• Comprehensive knowledge of US Good Clinical Practice (GCP), ISO 14155-2011 (GCP), Good Manufacturing Practices (GMP), Quality Systems Management (ISO 13485) and Good Laboratory Practices (GLP) requirements,
• Demonstrated experience in client service in the clinical research business.
• Demonstrated ability to motivate, lead, and grow a regulatory affairs team.
• Extensive demonstrated experience directing and supervising staff.
• Demonstrated high energy level, and excellent negotiation skills.
• Demonstrated ability to form strong working relationships across functional boundaries.
• Excellent written and verbal communication skills.
• Exceptional ability to conceptualize, develop, and manage timelines.

Qualifications: BS in Chemical Engineering with 10 years of Experience