Position: Director

Job type: Full-time

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Job content

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

No Agency Assistance Required

ROLE CAN BE BASED IN SWITZERLAND, UK, FRANCE, GERMANY, ITALY OR SPAIN

General Description

This position can interact at all levels of the organization responsible for creating, reviewing and/or authoring submission dossiers for Health Authorities located in EMEA (Europe, Middle, East, Africa). The incumbent should have knowledge of global guidance/regulations to support Regulatory/Reg Ops leaders outside EMEA.

The incumbent will provide leadership ensuring that the latest regional submission requirements and standards are met.

This position will provide strategic direction to the EMEA Publishing and Technical Editing function (e.g. Document Process, Reporting Publishing), as applicable.

Overview Of Essential Duties & Responsibilities
  • Work to establish Publishing and Technical Editing teams in collaboration with other Regional Submission Leads, under the guidance of the Director, Global SOM.
  • Strong project/submission management skills to drive the development and implementation of robust submission publishing activities associated with generating electronic/paper submissions. This includes working with internal staff and external vendors to produce regional compliant dossiers.
  • Deliver a service to our customers, through the planning, production, and distribution of submissions in EMEA.
  • Work with peers to drive the establishment of global submission processes (e.g. submission checklists, internal authoring standards, publishing timelines, and supporting tools) while providing strategic value to the overall positioning of the function.
  • Allocate publishing/technical editing resources; ensure compliance with global regulatory submission requirements and timeliness of submitting regional dossiers.
  • Responsible for resource allocation based on short and long-term filing plans and advises management of resource implications.
  • Provide direct oversight of multiple projects managed by staff. Participates in cross-functional project teams.
  • Analyze and improve activities to increase throughput in time-sensitive situations.
  • Communicate/report on “on-going” project status to management; sets expectations where necessary and takes decisions regarding issue resolution.
  • Articulate critical/complex issues, evaluate alternatives, and implement viable solutions.
  • Anticipate and proactively plan for submission expectations of the Regulatory team and EMEA Regional Regulators.
  • Collaborate with key internal stakeholders to ensure the regulatory submission strategy, deliverables, and timelines are incorporated and implemented into product objectives.
  • Support Regulatory Affairs Strategists with managing submission documentation, and internal review processes for regulatory dossiers.
  • Develop and maintain effective relationships with regulatory agency personnel, regulatory/reg ops peers, and consultants to optimize outcomes.
  • Provide submission gap analyses, proactively identify risks, and propose potential solutions/mitigation plans to ensure successful acceptance of submissions.
  • Build a strong partnership and communication vehicles with internal teams aligning resources to project expectations with consideration of possible project risks.
  • Maintain constructive and positive interactions with senior management and colleagues.
Core Competencies, Education And Skill Requirements
  • Bachelor’s Degree required.
  • Minimum of 10 years of industry experience; 8+ years of direct Regulatory Affairs/ Regulatory Operations experience
  • Preferred candidates will have experience working across two or more major geographic areas.
  • Significant experience within a Regulatory/ Regulatory Operations environment including hands on eCTD experience and broad industry standard systems knowledge.
  • Prior leadership and management experience.
  • Working knowledge of business software, including MS Word, Excel, PowerPoint, Project, Adobe Acrobat and Outlook.
  • Experience in the preparation and submission of documents using regulatory/document management systems (e.g. VAULT®, Documentum®, FirstDocs®, Publishing Tools, and Validation tools) is required
  • Ability to think strategically with a focus on process improvement and optimization.
  • Excellent verbal and written skills and attention to detail as well as time management and prioritization skills.
  • Demonstrated ability to balance multiple projects to achieve goals and meet deadlines and customers’ expectations.
  • Relevant experience includes project coordination/management, project management systems, electronic document management systems, global regulatory submissions or other experience directly related to project management and Regulatory Operations.
  • Familiarity with pharmaceutical development and global Regulatory submissions.
  • Organized with systematic approach to prioritization.
  • Process orientated to achieve the business objective.
  • Ability to learn new technologies and processes quickly.
  • Extensive experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, leading and managing regulatory operations teams, developing, and implementing regulatory operations strategies with a proven track record of accomplishments.
  • Strong business acumen and ability to make sound decisions that contribute positively to the business.
  • Strong strategic skills including creativity and effectiveness in identifying and addressing major challenges and the ability to balance short-term needs with long-term vision.
  • Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism.
Primary Job Requirements
  • Extensive experience with regulatory submission processes, documents, and requirements, such as INDs, clinical trial applications, Therapeutic Biologics Applications (BLA).
  • Excellent interpersonal skills with the ability to build strong relationships across multiple functions and organizations.
  • Ability to work independently and with the flexibility to handle workflow in a fast-paced environment.
  • Proven excellence in operational strategy.
  • Ability to interpret, communicate, and present regulatory information in a clear and concise manner.
  • Demonstrated ability to influence peers and external colleagues proactively and effectively across all levels of management.
  • Proven negotiation skills.
  • Self-starter, independent and a practical thinker, strong and passionate team leader.
  • Excellent verbal, written communications, and meeting presentation skills.
Competencies

Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically;

Upholds organizational values.

Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.

Communication - Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.

Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone’s efforts to succeed. Contributes to building a positive team spirit, Shares expertise with others.

Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.

Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.

Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.

Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully

Project Management - Communicates changes and progress; Completes projects on time and

budget.

No Agency Assistance Required

We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
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