CMC Regulatory Affairs Manager
Katalyst Healthcares and Life Sciences
Responsibilities:
- Lead the preparation, review, and submission of CMC sections of regulatory filings (e.g., INDs, NDAs, BLAs, MAAs, variations, renewals) to global health authorities, ensuring accuracy, completeness, and compliance with applicable regulations and guidelines.
- Provide regulatory guidance and support to cross-functional teams throughout the product development lifecycle, including manufacturing process development, technology transfer, scale-up, validation, and post-approval changes.
- Interpret and communicate regulatory requirements, guidelines, and expectations related to CMC to internal stakeholders, ensuring alignment with global regulatory strategies and objectives.
- Proactively identify regulatory risks, opportunities, and challenges related to CMC activities and provide strategic recommendations to mitigate risks and optimize regulatory outcomes.
- Collaborate with internal stakeholders, including Manufacturing, Quality Assurance, Quality Control, Supply Chain, and Clinical Development, to ensure regulatory compliance and alignment with business objectives.
- Establish and maintain positive relationships with regulatory agencies and industry peers, representing the company in regulatory interactions, meetings, and negotiations as needed.
- Stay abreast of emerging regulatory trends, changes, and developments related to CMC and communicate potential impacts to relevant stakeholders.
- Bachelor's, Master's, or Ph.D. degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or related scientific discipline.
- 5-7 years of experience in regulatory affairs CMC in the pharmaceutical industry.
- Demonstrated expertise in preparing CMC sections of regulatory submissions (e.g., INDs, NDAs, BLAs, MAAs, IMPDs) and interacting with global health authorities (e.g., FDA, EMA, Health Canada, PMDA).
- Strong understanding of global regulatory requirements, guidelines, and expectations related to CMC for pharmaceutical products (e.g., ICH guidelines, FDA regulations, EudraLex).
- Excellent communication, collaboration, and project management skills, with the ability to effectively interact with cross-functional teams and external stakeholders.
- Proven ability to prioritize tasks, manage multiple projects simultaneously, and meet deadlines in a fast-paced, dynamic environment.
- Detail-oriented mindset with a focus on quality, accuracy, and compliance.
- Experience with regulatory submissions for small molecules, biologics, or other pharmaceutical modalities is preferred.
- Regulatory Affairs Certification (RAC) is a plus.
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the CMC Regulatory Affairs Manager in Atlanta, GA vacancy
- ...preparation, review, and submission of CMC sections of regulatory filings (e.g., INDs, NDAs, BLAs, MAAs... ...-7 years of experience in regulatory affairs CMC in the pharmaceutical industry.... ...communication, collaboration, and project management skills, with the ability to...Suggested
Katalyst HealthCares & Life Sciences
Atlanta, GA1 day ago - ...Regulatory Affairs Manager In this critical role, you will lead regulatory strategies, product submissions, and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA...Suggested
Katalyst HealthCares & Life Sciences
Atlanta, GA1 day ago - ...delivering diagnostic solutions to some of the most critical questions in healthcare. Job Type: Full time Job Title: Regulatory Affairs Manager Location: Onsite - Atlanta, GA Position Summary: The Regulatory Affairs Manager will support the preparation,...SuggestedFull timeFlexible hours
CorDx
Atlanta, GA2 days ago $96.9k - $135k
A major specialty chemical supplier is seeking a Regulatory Manager in Atlanta, GA. This strategic role leads global regulatory affairs across various applications, ensuring compliance and managing risks. Responsibilities include overseeing regulatory documentation, maintaining...Suggested- JM Huber Corporation in Atlanta is seeking a Regulatory Affairs Manager to lead the global regulatory affairs function for Huber Specialty Minerals. This strategic role ensures compliance across diverse applications, including pharmaceuticals and food. The ideal candidate...Suggested
- A multi-national biotech organization in Atlanta is seeking a Regulatory Affairs Manager to oversee regulatory documentation for medical devices. The ideal candidate will have extensive experience in regulatory affairs, knowledge of FDA regulations, and the ability to...Flexible hours
- A leading logistics company in Atlanta seeks an Executive Assistance/Sales Program Manager responsible for managing strategic projects and supporting executive leadership. The role requires strong project management and analytical skills, with 3-5 years of relevant experience...
$85k - $105k
...patients win. Our ecosystem connects phlebotomists, clinical managers, couriers, independent physicians, nurse practitioners, and patient... ...'s full compliance program including HIPAA, CLIA, and state regulatory requirements → Develop compliance content and verbiage for...Full timeImmediate startASAP Results
Atlanta, GA3 days ago$150k - $225k
...employee relations efforts, HR compliance, HR Program and Project Management as well as ongoing identification of continuous improvement... ...regular audits and reviews to ensure adherence to legal and regulatory requirements. Own timelines for ongoing deliverables. Track...Work at officeLocal areaWorldwideVerifone
Atlanta, GA1 day ago- ...is seeking a Chief Compliance Officer to lead compliance efforts across its investment services. This critical role involves managing regulatory relationships, designing compliance programs, and ensuring systematic adherence to legal standards. The ideal candidate will...
$200k - $290k
...investment adviser (RIA) compliance program and serving as the primary regulatory‑facing executive for the firms. This role partners closely... ...organizations (including the SEC, FINRA, and MSRB), including managing routine interaction, regulatory inquiries, and examinations....Full timePart timeWork at officeShift workNight shiftDay shift- ...activities to ensure compliance with state and federal regulations. This role includes strategic direction and advice to senior management on regulatory matters. The ideal candidate has extensive experience in healthcare licensure and a strong understanding of regulatory...
$118.5k - $251.6k
...Job Description We are specifically looking for a ** Senior Manager of Data Center Compliance Integration** . You will be... ...engagement lead for all new data center products, sites, regions, regulatory frameworks, and material changes impacting the Data Center Compliance...Contract workTemporary workFlexible hoursOracle
Atlanta, GA1 day ago- ...The ideal candidate will have a Bachelor's degree, with a preference for a Master's, and at least 5 years of experience in grants management. This role involves ensuring compliance with Federal regulations and maintaining detailed grant files. Candidates must...
- ...Compliance Manager Do you want a career without limits? Do you want to shape your own future and be surrounded by people who listen... ...workflow coordination, and quality control to meet client and regulatory requirements. Essential Functions Uphold firm and...Local area
Smith + Howard
Atlanta, GA4 days ago - ...programs. The Corporate Director of Compliance informs up-line management of trends and makes recommendations for improved outcomes and... ...with coverage requirements, physicians’ orders, company policy, regulatory requirements, and accreditation standards. Responsible for...Permanent employmentTemporary workWork at officeLocal area
Gentiva
Atlanta, GA3 days ago $120k - $150k
...Piedmont Technical College is seeking a Chief Legal Officer responsible for providing legal guidance, managing the Legal Division, and overseeing compliance with regulatory standards. The role involves advising on executive decisions and managing grants related to federal...- ...and services, including lighting, lighting controls, building management solutions, and an audio, video and control platform. We focus... ..., including third‑party risk reviews, investigation support, regulatory documentation, and compliance recordkeeping. The position is...Flexible hours
Acuity Brands
Atlanta, GA2 days ago $200k - $225k
...hospitality company in Atlanta is seeking a Senior Director, Legal to act as the commercial legal leader. You will be responsible for managing commercial contracts, overseeing litigation, and developing risk management strategies. The ideal candidate has over 8 years of...Remote workKASA
Atlanta, GA4 days ago- ...of 7 years in compliance leadership, preferably within a public company. The successful candidate will enhance compliance programs, manage core components, lead training initiatives, and develop metrics for continuous program improvement. Strong collaboration,...
- ...high-growth phase. This role is being created to put a dedicated, senior owner on regulatory and clinical compliance for the first time in OVME's history. The role The Sr. Manager, Clinical Compliance is the single owner of OVME's regulatory and compliance posture...Remote jobTemporary work
OVME
Atlanta, GA17 days ago $22 per hour
...operations, ensuring inventory is maintained at appropriate levels. Identify reactive work order opportunities and communicate with management to propose changes. Communicate, implement and support process change initiatives as directed by management. Manage team...Casual workWork at officeLocal areaMonday to FridayAfternoon shiftIK Hofmann
Atlanta, GAa month ago- ...Job Description Job Description With the assistance of management, lead the development, implementation, and oversight of the Operations... ...submittals and filings, management updates, responses to regulatory advisories and inquiries, ballots, and, with input from management...
Georgia Transmission Corporation
Tucker, GA8 days ago - ...Solutions is a rapidly growing network of interventional pain management practices dedicated to helping patients reclaim their quality... ...incidents, and other compliance matters; ensure timely reporting to regulatory bodies. Assist with regulatory audits, policy development,...Full timeRemote workFlexible hours3 days per week
Resolve Pain Solutions
Atlanta, GA14 days ago - Job Description Job Description Responsible for the overall day-to-day activities surrounding Davis Bacon and Related Acts (DBRA) compliance . Duties include: • Ensuring that a weekly certified payroll is submitted electronically every week for every DBRA-covered...For contractorsApprenticeshipFor subcontractor
4P Consulting Inc.
Atlanta, GA20 days ago - Summary In the Compliance Manager role, you’ll lead multi-state and local indirect tax compliance engagements for clients across North... ...workflow coordination, and quality control to meet client and regulatory requirements. Essential Functions Uphold firm and AICPA and...Local area
$60k - $80k
...accommodation or an alternative application process. Compliance Manager CORP ATL, Atlanta, GA, US 20 days ago Requisition ID: 1347... ...position plays a key role in maintaining audit readiness, ensuring regulatory compliance, and driving continuous improvement initiatives....Immediate start- ...Investing. We are a fee-only financial advisory and portfolio management firm headquartered in Atlanta with offices throughout the U.S.... ...knowledge of the Investment Advisers Act of 1940, including the regulatory requirements applicable to SEC registered investment advisers...Work at officeLocal area
$159k - $215k
...currently seeking a talented, well-versed, and experienced Compliance Manager to serve as a subject matter expert on consumer protection... ...teams, and Legal and Compliance colleagues to provide regulatory guidance on new and existing products. Translate complex regulatory...- Stellantis Financial Services US is searching for a Reinstatement Team Manager in Atlanta, GA. The successful candidate will oversee the reinstatement process for delinquent accounts, collaborating with internal departments and external vendors to ensure compliance. This...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to CMC Regulatory Affairs Manager. Be the first to apply!
Related searches
- operations compliance manager Atlanta, GA
- regulatory affairs director Atlanta, GA
- regulatory manager Atlanta, GA
- head compliance Atlanta, GA
- director global regulatory affairs Atlanta, GA
- compliance manager Atlanta, GA
- manager regulatory affairs Atlanta, GA
- hr compliance manager Atlanta, GA
- compliance director Atlanta, GA
- senior director regulatory affairs Atlanta, GA