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Manager/Senior Manager Regulatory Diagnostics

Company: BeiGene, Ltd. APAC
Location: Ridgefield Park
Posted on: June 7, 2021

Job Description:

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.

General Description:

The Manager/Senior Manager, Diagnostic Regulatory Affairs will be responsible for developing, planning, and coordinating regulatory submissions in line with program strategies and cross-functional initiatives. This individual will represent Regulatory Affairs on cross-functional teams, provide guidance on In-Vitro Diagnostic regulatory strategies and tactics for therapeutic programs, and coordinate with key stakeholders, as required. The Manager/Senior Manager will also lead authoring of regulatory documentation and will partner with regulatory team members for management of regulatory documentation and submissions. Externally, this individual will interface with outside regulatory agencies for application submission and management.

Education Required:

Bachelor's degree required, Advanced degree preferred. Minimum 5 years of experience in the biotechnical, medical device or pharmaceutical industry and a minimum of 2 years experience in a Regulatory capacity, or 5 years experience in research & development of In-Vitro Diagnostic (IVD) development or Companion Diagnostics. Preferred candidates will have Regulatory Affairs experience with companion diagnostics and biomarker development.

Essential Functions of the job:

  • With minimal supervision, plan and manage regulatory activities related to assigned projects that span technical areas including clinical andnon-clinical.
  • Assist in developing and implementing strategies for the earliest possible approvals/clearance of IVD or Companion Diagnostic regulatory submissions associated with assigned programs
  • Manage the preparation, including writing as necessary, assembly, review, and timely submission of regulatory dossiers as required for investigation and registration of products in the US and abroad
  • Ensure regulatory submissions are maintained in compliance with regulatory requirements. Support and manage preparation of meeting requests and briefing documents
  • Manage the preparation, review, and submission of all components of regulatory submissions including INDs and amendments, BLAs/NDAs and supplements, annual reports, safety reports, etc. Participate on project teams and provide expertise on regulatory matters
  • Develop and maintain current regulatory knowledge and advise management of significant developments. Prepare and maintain regulatory archive. Work with external regulatory consultants/CRO's as required

Core Competencies, Knowledge & Skill Requirements:

  • Minimum 5 years of experience in the biotechnical, medical device or pharmaceutical industry and a minimum of 2 years experience in a Regulatory capacity
  • 3 years experience with In-Vitro Diagnostic and/or Companion Diagnostic development
  • Experience managing regulatory submissions and FDA interactions for In-Vitro Diagnostic Devices (e.g. PMA, 510(k), IDE) submissions)
  • Experience with pre-Submission process and have participated in meetings with CDRH
  • Experience with publishing documents in Adobe Acrobat Professional.
  • Working knowledge of FDA and ICH regulatory guidance and regulations
  • Understanding of FDA structure and function
  • Knowledge/experience with regulatory requirements for other regions also desirable
  • Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism

Communication & Interpersonal Skills:

  • Excellent verbal and written skills; able to analyze, define, and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to be internal and external stakeholders
  • Skilled in conflict resolution/negotiation. Fosters open communication. Listens and facilitates discussion.
  • Strong negotiating skills and ability to think creatively and develop creative solutions
  • Proven ability to build trust and respect within the organization.
  • Ability to prioritize and handle multiple projects simultaneously.
  • Interacts with external business partners and Regulatory Agencies.

Supervisory Responsibilities:

  • No

Competencies:

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

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.

Computer Skills: PC, including MS Office Suite

Other Qualifications:

Travel: ~20% and as required for business (may exceed 20%).

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.

Keywords: BeiGene, Ltd. APAC, Tenafly , Manager/Senior Manager Regulatory Diagnostics, Other , Ridgefield Park, New Jersey

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