Other Locations:US- NJ- Summit East
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Bachelors degree. Advanced degree preferred; Minimum of 15 years pharmaceutical industry experience with a minimum of 10 years in regulatory affairs leading strategy development and implementation in a cross-functional project team setting. Regulatory experience in multiple phases of drug development across various disease areas, with expertise in Hematology/Oncology diseases required; Demonstrated leadership in mentoring, building successful goal-oriented teams and supervising staff. Prior supervisory experience preferred.
Responsibilities will include, but are not limited to, the following:
- Accountable for the development and implementation of innovative global regulatory strategies within a team, disease or program to maximize the likelihood of regulatory success.
- Accountable for the planning and execution of submission strategy for major regulatory dossiers.
- Accountable for conducting regulatory risk planning and mitigation
- Accountable for maintenance of existing product portfolio and for life cycle management to ensure alignment with corporate objectives
- Accountable for resource planning and implementation consistent with strategic priorities, as appropriate.
- Provide information from regulatory team to support planning and maintaining the regulatory budget
- Represents Regulatory Affairs as a collaborative partner to provide strategic regulatory guidance
- Represents Regulatory Affairs on Disease Strategy Team, as appropriate.
- A member of the Hematology/Oncology Regulatory Leadership Team, as appropriate.
- Represent Regulatory Affairs at corporate governance committees, as appropriate, providing strategic advice to senior management throughout the development of a product.
- Represent Regulatory Affairs on due diligence activities and alliance management partnership programs
- Participate in or lead internal cross-functional initiatives, as appropriate
- Participate in or lead industry initiatives (eg, workshops, symposia etc)
- Maintain oversight of, or participates in key interactions with health authorities and communicate health authority feedback as appropriate to Regulatory Leadership Team
- Maintain oversight of the development and maintenance of internal Global Regulatory Affairs practices and procedures
- Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidance.
- Maintain knowledge of the disease areas through regulatory intelligence, KOL interface etc; interpret and impart this knowledge within the disease areas and to stakeholders
- Supports Celgene priorities in Regulatory Policy, intelligence and Science
- Lead, mentor and guide development of talent within the team, which includes succession and development planning, performance management, and recognition
- Bachelor’s degree; Advanced degree preferred
- Minimum of 15 years pharmaceutical industry experience with a minimum of 10 years in regulatory affairs leading strategy development and strategy implementation in a cross-functional project team setting
- Regulatory experience and knowledge in multiple phases of drug development across various therapeutic areas, with expertise in Hematology/Oncology diseases required
- Demonstrated experience in strategic planning, preparing and leading global dossier submissions (eg, US, EU, etc)
- In depth knowledge of current global regulations and guidance (eg, US, EU, ICH, etc) essential as they relate to the overall global regulatory strategy
- Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously
- Demonstrated ability and credibility to anticipate, analyze and resolve complex global regulatory related problems and ability to cope with ambiguity
- Demonstrated management experience with direct report and in-direct report supervision
- Demonstrated ability to effectively lead, coach and mentor colleagues
- Anticipate future needs within the function when selecting and developing talent (eg, develops successors and talent pools for key positions)
- Domestic and occasional International travel is required
- Results driven and team-orientated with the ability to influence outcomes as necessary skills in the environment
- Demonstrated ability to use scientific and clinical knowledge to conceptualize study designs
- Proficiency in data interpretation
- Display a willingness to challenge the status quo and take risks through innovation
- Cultivates internal and external networks of people across a variety of functions and locations
- Able to develop and actively use external relationships with key stakeholders to reinforce Celgene’s regulatory credibility
- Excellent skills in oral and written communication, including effective presentation skills to clearly articulates ideas, opinions and information
- Excellent interpersonal skills and ability to communicate effectively across Global Regulatory Affairs and across the different organization functions
- Good listening skills and a strong willingness/desire to help resolve issues faced by others around them
Celgene Leadership Competencies
- Drive Innovation and Results
- Shape Strategy
- Attract and Develop Talent
- Promote Open Communication
- Create Global Mindset
- Demonstrate Adaptability
- Foster Risk Taking
- Foster Teamwork
- Passion for the Patient
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.