CambridgeRecruiter Since 2001
the smart solution for Cambridge jobs

Associate Director, Regulatory Affairs

Company: BeiGene
Location: Cambridge
Posted on: March 28, 2020

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 Associate Director/Director, Regulatory Affairs will be 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, and in coordination with key internal stakeholders. This individual will manage regulatory aspects of compounds through all phases of development, post-approval, and life-cycle of the product. 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 to plan, evaluate and recommend regulatory strategy. Externally, the individual will interface with outside regulatory agencies and business partners regarding development, regulatory, and registration strategies. He/she will also provide line management, people development, and performance management as well as support/lead development and implementation of department policies.

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 domestic and international markets, regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority interactions
  • Uses extensive knowledge of US, EU 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
  • Reviews sections of IND/CTA, NDA/MAA, 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
  • 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 create a goal oriented culture


    • Minimum 10 years of experience in the biotechnical or pharmaceutical industry, and a minimum of 5 years' experience in a Regulatory capacity with a broad background
    • Preferred candidates will have experience working as a lead in Regulatory Affairs across two or more major geographic areas, and prior experience with both small molecules and biologics
    • Thorough understanding of drug development process and the pharmaceutical industry and healthcare environment including regulatory requirements and policy trends
    • Extensive regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with Health Authorities, leading and managing regulatory teams, developing and implementing regulatory strategies with a proven track record of significant regulatory accomplishments
    • Strong business acumen and ability to make sound decisions that contribute positively to the business
    • Very strong strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges (e.g., new competition, shifting market environment) 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

      Education Required: Bachelor's degree required, advanced degree preferred

      Communication and 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

        Travel: 10 - 20% of time, as required


        Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically in accordance with BeiGene's Code of Business Conduct and Ethics, policies and procedures.

        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 and 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 within budget.

        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, Cambridge , Associate Director, Regulatory Affairs, Executive , Cambridge, Massachusetts

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

Nurse Manager Cardiac Cath Lab
Description: - -- An award-winning hospital system in Massachusetts--is looking to add a proven leader to join their Cardiac Catheterization Lab management team. This is a wonderful opportunity for an ambitious Healthcare--Professional (more...)
Company: Clinical Management Consultants
Location: New Bedford
Posted on: 04/11/2020

Nurse Manager Hospital Operations
Description: An exciting position is now available for a Nurse Manager of Hospital Operations at a prestigious hospital in the Greater Boston area.-- This short term acute care hospital is located just outside the (more...)
Company: Clinical Management Consultants
Location: Peabody
Posted on: 04/11/2020

Operating Room Clinical Nurse Director
Description: An exciting opportunity is now available for an Operating Room Clinical Nurse Director at an innovative hospital in Rhode Island.-- The Operating Room Clinical Nurse Director will join a nationally recognized, (more...)
Company: Clinical Management Consultants
Location: Warwick
Posted on: 04/11/2020

Area Sales Director - Lighting Experience
Description: Are you passionate about Building Financial Security Are you interested in developing your career with a technology powerhouse who empowers entrepreneurs' creativity to change, challenge, and influence (more...)
Company: Titan LED
Location: Portland
Posted on: 04/11/2020

RN Manager of Professional Development and Clinical Education
Description: A unique opportunity is now available for an RN Manager of Professional Development and Clinical Education The RN Manager of Professional Development and Clinical Education will join a 200-bed hospital (more...)
Company: Clinical Management Consultants
Location: Plymouth
Posted on: 04/11/2020

Director of Hospital Facilities Management
Description: A Magnet designated acute care hospital located just outside of the Greater Boston area is currently searching for an experienced Director of Hospital Facilities Operations to join their award-winning (more...)
Company: Clinical Management Consultants
Location: Lawrence
Posted on: 04/11/2020

Area Sales Director - Lighting Experience
Description: Are you passionate about Building Financial Security Are you interested in developing your career with a technology powerhouse who empowers entrepreneurs' creativity to change, challenge, and influence (more...)
Company: Titan LED
Location: Nashua
Posted on: 04/11/2020

Nurse Director Perioperative Services
Description: A great opportunity for a Nurse Director Perioperative Services is now available in beautiful New England at a fantastic short term acute care hospital.-- This is an ideal position for somebody who wants (more...)
Company: Clinical Management Consultants
Location: Concord
Posted on: 04/11/2020

General Manager
Description: General Manager Job Description -- If you're a positive, burrito-loving, high performer and a born leader, then we want to talk to you As the General Manager, you'll enjoy the following work-related (more...)
Company: Qdoba
Location: Cranston
Posted on: 04/11/2020

Assistant Nurse Manager Case Management
Description: A beloved community medical center in beautiful Massachusetts is now hiring for an Assistant Nurse Manager Case Management to join their Care Management and Utilization Review leadership team. Reporting (more...)
Company: Clinical Management Consultants
Location: Attleboro
Posted on: 04/11/2020

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Cambridge RSS job feeds