At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients. We are looking for experienced Quality professionals to help us reach our ambitious goals.
As the Sr. Regulatory CMC Facilitator, you will support and facilitate on-site regulatory CMC related launches and post-approval activities of the site-specific products to ensure timely supply to the markets in compliance with current regulatory obligations and requirements. Champion regulatory compliance and consistency through representation in initiatives and experience sharing within and outside the site. This role will report to the Head of Quality.
Key Responsibilities:
• Act as primary liaison with Global and Country Quality/Regulatory teams to stay informed of new regulatory requirements, knowledge of global product dossiers and submission strategies. Collaborate and provide advice on the implementation of new regulatory requirements and guidance on regulatory and change control related aspects.
• Enhance site understanding of relevant regulatory issues and topics through training, information sharing and collaboration on projects. Coach and support site personnel on all regulatory specific aspects of change management to maintain site regulatory compliance.
• Evolve Change Control practices and be a strategic leader of compliance best practices across the RLT platform. Participate in the CMC facilitator network sharing lessons learned, providing expertise to facilitators from other sites.
• Routinely monitor and report to site leadership key metrics regarding site compliance in executing Change Controls. Identify needs and lead cross-functional/cross-site initiatives as applicable to improve processes.
• Maintain good quality source documentation, ensuring regulatory compliance, quality oversight and adherence to best practices. Monitor project scope, timing, and progress of submission-related activities.
• Provide on-site coordination, guidance and support for the preparation of CMC responses to Health Authority (HA) commitments, within expected timelines.
• Support and address issues related to regulatory compliance checks. Maintain oversight of any compliance activities at the site, ensuring appropriate handling and prompt completion.
• Mentor site personnel on compliance SOPs and regulatory processes.
• Provide regulatory support during on-site HA inspections.
Additional Notes:
• This role is Monday-Friday, day shift, located on-site at our Millburn, NJ location.
Commitment to Diversity & Inclusion:
We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:
Role Requirements
• Bachelor’s degree in Science (e.g., Chemistry, Pharmacy, Biotechnology, Biochemistry, Biology) or equivalent required.
• Advanced degree preferred.
• 8+ years’ experience in Quality, Compliance, and/or Regulatory Affairs CMC, within pharmaceutical manufacturing required.
• 3+ years’ experience in Regulatory Affairs CMC required.
• Demonstrated ability with leading, executing, and documenting both complex change controls and regulatory strategies.
• Excellent organization, communication, and collaboration skills.
Desirable Requirements:
• Previous Radio pharma experience a plus
• Demonstrated experience managing and/or mentoring of team members is a plus.
Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: People and Culture | Novartis.
Pay transparency statement: The pay range for this position at commencement of employment is expected to be between $144,000 and $216,000 a year; however, while salary ranges are effective from 1/1/23 through 12/31/23 fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards
Accessibility and Reasonable Accommodations: The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: Novartis Talent Pool.
About the roleBringing life-changing medicines to millions of people, Novartis sits at the intersection of cutting-edge medical science and innovative...
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