General Electric Company

Associate Director, Regulatory Affairs, CMC

General Electric Company • $132K — $198K *
US-AnywhereRemote in United States
Pharmaceuticals & Biotech
Less than 5 years of experience
Reposted Today
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Job Overview by Ladders

Qualifications

  • Advanced degree in pharmacy, radiopharmacy, pharmaceutical sciences, chemistry, or related discipline (PharmD or MSc in radiopharmacy preferred).
  • Minimum of 3 years in Regulatory Affairs or Quality with experience supporting marketed products and/or clinical development of radiopharmaceuticals.
  • Familiarity with PET production and GMP requirements for radiolabeled compounds.
  • Strong problem-solving and negotiation skills in a regulated environment.
  • Proficient in written and oral English for clear communication.

Responsibilities

  • Act as the regulatory CMC strategy point of contact for project teams.
  • Build submission strategy documents identifying necessary data and document types for packages.
  • Guide project teams during planning to ensure data is correctly collected for all markets.
  • Author and review CMC submission documents to support regulatory submissions.
  • Provide expert regulatory advice to deliver business value and mitigate compliance issues.
  • Maintain registration tracking and develop document management practice standards.
  • Collaborate with global and regional regulatory affairs to address authority inquiries.

Benefits

  • Medical, dental, and vision insurance.
  • Paid time off and 401(k) plan with employee and company contributions.
  • Life, disability, and accident insurance.
  • Tuition reimbursement for continuing education.
Full Job Description
Job Description Summary
We are seeking a highly motivated and detail-oriented Regulatory Affairs – CMC professional with a strong background in radiopharmacy or radiopharmaceutical development. The successful candidate will support global regulatory strategy and execution for both marketed and development-stage radiopharmaceutical products involving PET and SPECT tracers. This is a cross-functional role requiring close collaboration with CMC, QA, manufacturing, and supply chain teams to ensure continued regulatory compliance and support for post-approval changes across global markets.

Job Description

Roles and Responsibilities

  • To be the regulatory CMC strategy point of contact for project teams and to provide CMC related regulatory input for the assigned projects/products.
  • Build, or provide input to, submission strategy documents by defining supplement type, data required to support submission, and submission documents required for the submission package.
  • Guide the project team in the project planning phase so that the correct data (and level of detail) to suit the needs of all markets is collected and submitted.
  • Author and review individual CMC submission documents/CMC dossier sections to support regulatory submissions.
  • Provide consistent expert advice to the organization, determining feasible regulatory strategies and identify potential options, to assist in delivering optimal business value or mitigate compliance issues.
  • Maintain registration tracking information and assist in the development of good document management practice standards.
  • Work closely with global RA and, regional RA’s to address questions from regulatory authorities.

Required Qualifications

  • Advanced degree in pharmacy, radiopharmacy, pharmaceutical sciences, chemistry, or related discipline (Doctor of Pharmacy (PharmD) or MSc in radiopharmacy preferred).
  • Minimum 3 years of experience in Regulatory Affairs or Quality, with a track record of supporting marketed products and/or clinical development of radiopharmaceuticals.

Desired Characteristics

  • Familiarity with PET production, automated synthesis (cassette-based systems), and GMP requirements for radiolabeled compounds.
  • Experience with regulatory submissions for post-approval changes, including FDA supplements and EU variations.
  • Ability to prioritize, plan & evaluate deliverables to established strategic goals for complex projects, including scientific discussions on how best to present information. Strong problem solving and negotiation skills.
  • Demonstrated experience of operating in a highly regulated environment. Capable of applying analytical skills in a CMC regulatory environment.
  • Has experience working within a matrix organization and has strong interpersonal and influencing skills to work across disciplines. Has the capability to influence managers and help drive decisions at a project level.
  • Demonstrated knowledge & experience in scientifically related field e.g. pharmaceutical sciences, chemistry and analytical sciences.
  • Demonstrated strong ability in written and oral English in order to clearly and concisely present information targeted to the relevant audience.
  • Experience in pharmaceutical CMC regulatory or QA environment particularly with experience with injectable diagnostic or pharmaceutical products. Ability to interpret global regulations and present to the wider business.
  • Experience in electronic document management and Quality management systems.
  • Ability to proactively champion projects & experienced in mentoring team members.
  • Knowledge of international CMC regulatory requirements.
  • Strong interpersonal skills and ability to engage effectively with colleagues at all levels.
  • Prior regulatory agency interaction experience (e.g., query responses, scientific advice, deficiency letters).
  • Experience of global regulatory affairs from the pharmaceutical and/or healthcare industry.
  • Experience of regulatory project management and regulatory agency interactions.
  • Experience with Veeva RIM or other registration tracking tools.
  • Ability to work across cultures/countries/sites.
  • Demonstrated experience of prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.

We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $132,000.00-$198,000.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

Additional Information

Relocation Assistance Provided: No

Application Deadline: July 06, 2026

About General Electric Company

GE Healthcare provides medical technology, intelligent devices, and care solutions. They offer medical imaging, information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies. GE Healthcare's mission is to improve patient care and outcomes by providing innovative healthcare solutions. Their technologies are used in hospitals, clinics, research institutions, and pharmaceutical companies worldwide to diagnose and treat various medical conditions.

General Electric Company Careers

Join the dynamic team at General Electric Company, a global leader in innovation and technology. As one of the most respected companies worldwide, we offer unparalleled job opportunities that propel your career to new heights. Work You’ll Do At General Electric Company, you’ll be part of a diverse team committed to transforming industries and improving lives through leadership in sectors such as aviation, power, renewable energy, and healthcare. Our culture thrives on innovation and leadership, fostering an environment where you can grow professionally and personally. Lead in a Unique Market Position General Electric Company stands at the forefront of digital and industrial transformation. Here, you’ll leverage your skills to solve complex challenges, drive growth, and lead projects that have a global impact. Our commitment to professional development and diversity training ensures that every team member is equipped to lead and innovate. Collaborate with Industry Experts Work alongside a global network of professionals, each bringing a wealth of knowledge and experience to our collaborative projects. General Electric Company’s culture of inclusivity and teamwork makes it a prime environment for networking and personal development. Innovative Work Join us to work on groundbreaking projects that redefine what’s possible. Our teams at General Electric Company are constantly pushing the boundaries of technology and innovation to create solutions that not only meet but exceed the needs of our customers and communities around the world. Be Part of a Great Team At General Electric Company, we understand that our employees are our greatest asset. That’s why we offer competitive benefits, extensive career advancement opportunities, and a supportive environment that values work-life balance. Our commitment to employee growth is reflected in our robust training programs and our focus on internal mobility. Future-Proof Your Career With a career at General Electric Company, your growth is limitless. Through our various training programs, internships, and leadership development initiatives, you can enhance your skills and advance your career in a direction that aligns with your professional and personal aspirations. Explore Job Opportunities and Internships Whether you’re starting your career or looking to make a significant impact in your field, General Electric Company offers a range of positions and employment opportunities that cater to your talents and ambitions. From internships that provide real-world experience to leadership roles that challenge your strategic thinking, there’s a place for you here. Stay Connected Join Our Team Search open positions that match your skills and interests. We are always on the lookout for passionate, curious, and solution-driven team players. Explore the possibilities that await you at General Electric Company. Keep Up to Date Stay informed with career tips, insider perspectives, and industry-leading insights—all from the people who work here. At General Electric Company, we’re more than a company—we’re a community. Job Alert Emails Customize your subscription to receive job alerts, the latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding career opportunities available at General Electric Company and become part of a team that’s reshaping the future of technology and industry. Join General Electric Company today and be a part of our journey to build a better world through essential technology and innovative solutions. Your career at General Electric Company awaits—explore, innovate, and lead with us.
Learn more about General Electric Company
Size
168,000 employees
Market Cap
$90.4 billion
Industry
Business Services
Net Income
$5.7 billion
Founded
1892
5 Year Trend
-9.1%
Revenue
$79.6 billion
NASDAQ
GE
* Ladders Estimates

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