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Job description
Job Description
This Role is responsible for developing and implementing Chemistry, Manufacturing and Control regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidances and defined regulatory strategies, in addition to the preparation and review of information required for development of regulatory Chemistry, Manufacturing and Control dossiers for commercial products-
Our Regulatory Affairs team brings new medical advancements to the world by-facilitating communications and procedures that allow swift, organized compliance-across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical-products, practices and solutions to the world. Your role at our organization is integral-to helping the world meet new breakthroughs that affect generations to come, and-we're counting on your skills and inventiveness to help make meaningful contributions-to global medical advancement.
Regulatory Responsibilities
Lead global product and project regulatory strategies by identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks.
Execute regulatory strategies by leading the development, authoring and review of Chemistry, Manufacturing and Control submission components and documentation to support approval supplements/variations, Drug Master Files, New Drug Application/Biologics License Application/Marketing Authorization Application, Annual Reports, Commitment and responses to health authority questions--
Liaise with global Chemistry, Manufacturing and Control, Manufacturing Division and external partners including Contract Manufacturing Organizations to-support compliant execution of change management and conduct all activities-with an unwavering focus on regulatory conformance.
Assess and communicate potential regulatory risks and propose mitigation strategies.
Deliver all regulatory milestones for assigned products across the product-lifecycle-
Technical Skills
Experience in reviewing scientific information to assess technical merits and-suitability of scientific rationale to ensure information is presented clearly and-conclusions are adequately supported by data.
Demonstrated oral and written communication skills and the ability to-communicate issues in a succinct and logical manner. Strong listening skills.
Demonstrated understanding of related fields (e.g., manufacturing, analytical testing, and quality assurance).
Proficient computer skills and previously demonstrated ability to operate in-electronic document based GMP systems-including Veeva.
Leadership Skills
Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders.
Demonstrated flexibility in responding to changing priorities or dealing with-unexpected events.
Capability to handle multiple priorities and balance work to achieve business goals.
Demonstrated effective leadership, communication, and interpersonal skills
Qualifications & Skills
Bachelor's in science, Engineering, or a related field (advanced degree-preferred but not required). Fields of study include Pharmacy, Chemical-Engineering, Biology, Microbiology, Virology, Molecular Biology, or-Biochemistry-
Preferred: At least 5 years pharmaceutical industry experience, or up to 3 years' experience in managing Chemistry, Manufacturing and Control Regulatory submissions for small molecules/vaccines/biologics. Experience in Veeva.
Required Skills
Adaptability
Biologics License Application (BLA)
Cross-Cultural Awareness
Detail-Oriented
Electronic Common Technical Document (eCTD)
Employee Training Programs
International Regulatory Compliance
Pharmaceutical Process Development
Regulatory Affairs Management
Regulatory CMC
Regulatory Strategy Development
Regulatory Submissions
Regulatory Writing
Strategic Thinking
Technical Writing
US and Puerto Rico Residents Only
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds.
The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
The salary range for this role is $142,400.00 - $224,100.00
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at .
San Francisco Residents Only
We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only
We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
Employee Status
Regular
Relocation
No relocation
VISA Sponsorship
No
Travel Requirements
No Travel Required
Flexible Work Arrangements
Hybrid
Shift
1st - Day
Valid Driving License
No
Hazardous Material(s)
n/a
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Worksite address
rahway, NJ, 07065, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.