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9 days old

Regulatory Affairs Manager

Kelly Services
Springfield, NJ 07081
Kelly Science, a global staffing and solutions provider of specialty talent, is currently recruiting a **Regulatory Affairs Manager** for a radiopharmaceutical company with operations in Springfield, NJ. The state-of-the-art facility provides contract development and manufacturing services for radiopharmaceutical companies, including therapeutics and centrally distributed diagnostics. The company expects rapid growth in the next few years. They are a small team, where all team members support each other in a variety of activities and are looking for team members who are motivated to take on new challenges and excited to help build the company. Partial equity-based compensation packages possible.


**Responsibilities:**


+ Ensure compliance with FDA/EMA guidelines for NDA/MAA/IND/IMPD product manufacture

+ Manage the CMC regulatory activities for multiple projects simultaneously and respond readily to changing events and priorities

+ Lead the development of regulatory strategy and update strategy based upon regulatory changes

+ Strategize development and creation of CMC submission documents from early-phase clinical submissions through to marketing applications and lifecycle activities

+ Contribute to therapeutic area strategic product development

+ Oversee and review recommendations and implementation of improvements introduced by new regulations, agency guidance documents, industry standards, new technologies and internal needs

+ Edit public-facing literature/documents/content, create company-wide style guide, etc.

+ Maintain awareness of science and industry trends and integrate appropriately into work focus

+ Prepare site for regulatory inspections

+ Write/review/approve standard operating procedures, batch records, specifications, validation protocols and reports, and instrument acquisitions/decommissions, as applicable

+ Optimize procedures and processes company-wide to ensure effective operation

+ Lead and drive all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for projects/products, while applying global strategy to submissions

+ Ensure timely completion, accuracy, and quality of all regulatory and submission documentation across product life cycle

+ Streamline regulatory documentation process and provide strategic guidance and best practices

+ Identify required documentation and any content, quality, and/or timeline issues for global submissions; negotiate the delivery of approved technical source documents in accordance with project timelines

+ Strategically convert scientific data into clear, well-structured, scientifically sound, regulatory documents intended for global health authorities and stakeholders


**Education and Qualifications:**


+ 5 years+ pharmaceutical industry regulatory experience

+ Experience directly interacting with FDA, ideally in lead role

+ Minimum Bachelors Degree, but advanced scientific degree preferred

+ Knowledge of Radiopharmaceuticals a plus

+ Excellent communication skills

+ Excellent technical writing skills

+ Self-starter with strong problem solving skills


**Interested? Apply today and send updated resumes to Chelsea.Crosier@kellyscientific.com for immediate consideration!**


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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Posted: 2022-09-19 Expires: 2022-10-20

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Regulatory Affairs Manager

Kelly Services
Springfield, NJ 07081

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