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Manager/Sr Manager Regulatory Affairs New Markets

Company: BeiGene
Location: Des Moines
Posted on: September 24, 2022

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: Responsible for developing, implementing, and advising on global regulatory strategies for development programs to secure and maintain market access for product(s) in line with business objectives, with a focus on developing these capacities in jurisdictions where BeiGene does not yet have affiliates. The role will include building a team that facilitates the submission of BeiGene applications in these regions, either directly or through business partners, with a focus on jurisdictions in Latin America initially, and potentially other territories as the groups experience grows. This individual will facilitate business partners regulatory interactions with health authorities of BeiGene assets through all phases of development, post-approval, and lifecycle. The incumbent will provide leadership and strategic regulatory oversight for designated projects ensuring that the latest requirements and standards are met. The individual has departmental and corporate-level influence and acts as an advisor/liaison to senior management in order to plan, evaluate and recommend regulatory strategy. Externally, the individual will interface with outside Health Authority Agencies, local regulatory colleagues, vendors, and business partners regarding development, regulatory guidance, evaluation and registration strategies. They will provide line management, people development, and performance management as well as support/lead development and implementation of department policies. In this role, you will be responsible for ensuring availability of contemporary regulatory documentation to formulate regulatory strategy to achieve competitive and accelerated product approvals.Essential Functions of the job:

  • Provides high level strategic and operational regulatory direction and mentorship on projects including, but not limited to, general regulatory strategies, regulatory requirements for clinical studies and marketing approval in international markets with a focus on Latin America, and critical issue management and advice on Health Authority interactions in these regions.
  • Solid and extensive regulatory experience, including knowledge of regional regulations and ICH regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues to support corporate goals.
  • Oversees the preparation and submission of documentation to support investigational and marketing registration packages throughout the world and ensures timelines are met.
  • As the role develops, will be responsible for review of sections of IND/CTA, NDA/MAA/NDS, and other global submission documents in support of clinical trials and marketing applications, and their amendments in conformance with local regulatory requirements.
  • Liaises and negotiates with global regulatory authorities as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals of product and labeling changes.
  • Maintains awareness of global regulatory environment and assess impact of changes on business and product development programs. Facilitate policy and development of standard interpretation of global regulation.
  • Integrates functional expertise with business knowledge to solve problems and make good decisions for the overall business.
  • Perform complex compliance risk versus business benefit scrutiny in ambiguous situations and formulate a recommendation for action, review with stakeholders and drive resolution.
  • Trains, develops, and manages an effective regulatory team both via direct and indirect reporting structure. Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise.
  • Manages critical issues, taking leadership for the regulatory contribution Responsible for assisting with the development and implementation of regulatory processes.
  • Recruits, develops, manages, and mentors regulatory professionals and helps sustain BeiGenes mission and culture.Education Required:Minimum of 7+ years in pharmaceutical industry and a Bachelor's degree or 5+ years and an advanced degree.Supervisory Responsibilities:
    • Extensive supervisory responsibilities for multi-level regulatory team(s), with opportunity to grow the supervised organizational structure.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.Computer Skills: Extensive experience with Microsoft Office suite; Veeva regulatory publishing; expertise with PowerPoint presentation authoring, charts and presentation.Other Qualifications: must be detail-oriented and able to manage multiple priorities, skilled in written and verbal communications; manages ambiguity, strategic mindset, demonstrates self-awareness, cultivates innovation, and develops talentLanguage Skills : Excellent written and verbal communication skills. Spanish (desirable).Travel: Business travel to be 10-20% as required; negotiable.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, 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, Des Moines , Manager/Sr Manager Regulatory Affairs New Markets, Executive , Des Moines, Iowa

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