This Associate Director, Regulatory Affairs will work on-site at our Alameda, CA location in the Diabetes Care Division. We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. This is an exciting opportunity to shape and execute regulatory strategies across the total product life cycle, driving innovation in next-generation diabetes management and digital health technology solutions.
Compensation
The base pay for this position is $148,700.00 – $297,300.00
Responsibilities
Develop global regulatory strategies for product development and planning throughout the product lifecycle
Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions
Provide technical leadership and strategic input on complex issues and to business units
Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams
Develop and communicate a vision for the organizational unit assigned
The Regulatory Affairs Specialist II supports regulatory compliance and product safety for Clorox’s FDA-regulated Foods portfolio in the U.S. and Canada, as well as the Kingsford business. This role helps bring new products to market and ensures existing products remain compliant by interpreting regulations, assessing risks, and providing practical guidance that balances business needs with regulatory requirements.
Compensation
The applicable salary range for every role in the U.S. is based on your work location and is aligned to one of three zones according to the cost of labor in your area. –Zone A: $90,900 - $170,100
–Zone B: $83,400 - $155,900
–Zone C: $75,800 - $141,700
Responsibilities
Serve as the regulatory representative on cross-functional project teams, providing proactive, risk-based guidance, including support for the Canada Foods business.
Review formulations, supplier documentation, claims, ingredient statements/nutrition information, and labels to ensure regulatory compliance for product innovation and commercialization.
Interpret regulations to recommend compliant and commercially viable pathways and be able to translate complex regulatory requirements into clear, practical guidance for stakeholders.
Identify regulatory risks early and propose mitigation strategies.
Support licensing activities, as needed.
Requirements
Bachelor of Science degree in a relevant technical field (e.g., Food Science, Nutrition, Chemistry, Biology)
Provides regulatory oversight, and strategic guidance on promotional and non-promotional communications or activities for assigned BeOne marketed products in North America.
Locations (2)
United States
Canada
Compensation
Salary Range: $176,000.00 - $236,000.00 annually
Responsibilities
Oversees the regulatory review process for promotional materials in conformance with local regulatory requirements and company policy, and to ensure consistency with approved labeling.
Provide advice and guidance on healthcare regulations applicable to the development and commercialization of BeOne’s products in North America.
Provide strategic guidance on commercial product labeling as part of the Labeling Working Group.
Serve as the lead regulatory representative on various cross-functional teams, including promotional and medical review committees.
Collaborate and participate on cross-functional teams for product labeling, product development teams, medical affairs, and marketing.
The Director, Regulatory Affairs will be responsible for developing, implementing, and advising on North America (NA) regulatory strategies for development programs to secure and maintain market access in NA for product(s) in line with business objectives.
Compensation
Salary Range: $176,000.00 - $236,000.00 annually
Responsibilities
Provide high level regulatory strategic and operational direction for NA and mentorship on projects
Oversee the preparation and submission of documentation to support investigational and marketing registration packages within the US and Canada
Liaise and negotiates with the FDA and Health Canada as needed for all aspects pertaining to drug development
Trains, develops, and manages an effective regional regulatory team
Requirements
Bachelor’s degree
advanced degree preferred
Nice to have: Experience working as a lead in Regulatory Affairs with the FDA
Nice to have: Experience with small molecules and biologics
The Regulatory Affairs Manager ensures compliant market access for diverse portfolios (medicines, devices, cosmetics, foods) by leading product registration, labeling, and claims aligned with commercial goals. They maintain ongoing compliance, manage health authority interactions, and oversee submissions and inspections.
Responsibilities
Lead the end-to-end regulatory process for new product launches and lifecycle maintenance (NPD & Line Extensions), utilizing systems like Veeva Vault to prepare dossiers, secure registrations, and ensure compliant labeling and claims aligned with commercial plans.
Develop robust regulatory strategies (e.g., RSD) and conduct gap analyses to identify risks early; proactively manage the impact of regulatory changes and propose solutions to ensure products are scientifically robust and legally compliant.
Act as a strategic partner to Marketing, Sales, Supply Chain, and QA teams, embedding regulatory requirements into business processes (e.g., Quality Agreements, TTS); maintain SOPs and compliance databases to drive operational efficiency.
Serve as the primary point of contact for Health Authorities and industry bodies, managing inspections, responding to queries, and building strong relationships to facilitate smooth approvals and negotiations.
Monitor global and local regulatory landscapes (including e-commerce and sustainability trends), analyze impacts on the portfolio, and establish robust safety review processes to ensure product integrity and compliance.
Lead regulatory strategy and oversight for companion diagnostics and in vitro diagnostic products, managing a team of regulatory professionals and coordinating with global stakeholders.
Compensation
$231,900.00 - $365,000.00
Responsibilities
Develop and oversee global regulatory strategies for companion diagnostics and IVD products
Provide strategic and tactical CDx/IVD regulatory guidance
Manage regulatory activities related to development, registration, approval, and lifecycle management
Lead regulatory interactions with external partners and authorities
Oversee preparation and approval of regulatory submissions
Requirements
Bachelor’s degree in a biological science, chemistry, engineering, regulatory science, or a related discipline
Supports the development and successful performance of the CMC regulatory strategy for the innovative pipeline of Cell & Gene Therapies.
Locations (4)
Santa Monica, California, United States
Gaithersburg, Maryland, United States
Boston, Massachusetts, United States
Cambridge, Massachusetts, United States
Compensation
The annual base pay (or hourly rate of compensation) for this position ranges from $135,624.80 - $203,437.20 USD Annual. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles).
Manager / Associate Director - Global Regulatory Strategy (Respiratory, Immunology & Inflammation)
gsk.wd5.myworkdayjobs.com/GSKCareers · Posted Nov 9, 2026
Develop and execute global and regional regulatory strategies for respiratory, immunology and inflammation assets, ensuring compliance and effective regulatory interactions across multiple markets.
Interpret global regulations and guidance to identify risks and provide input for guidance to cross functional product teams.
Partner with cross-functional stakeholders to deliver regulatory dossiers (e.g. CMC component(s) of IND / IMPD / BLA/ Master Files, amendments, annual reports) and health authority interaction briefing documents.
Manage regulatory dossiers throughout the product development lifecycle.
Support Reg CMC activities in complex programs.
Provide review and compilation and ensure that submission documents and correspondence are of the highest quality in terms of content, organization, clarity, and accuracy.
If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $138,600 to $231,000. The US salary ranges take into account a number of factors including work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role.
Responsibilities
Proactively develop regulatory strategies for local and global regions
Implement regional strategies to support global projects
Manage regulatory interactions and review processes in local regions
Ensure compliance with global/regional requirements at all stages of product life
Assess regulatory intelligence and competitive environment
Requirements
Degree-educated in relevant scientific or technical discipline
Nice to have: knowledge of all phases of drug development
Nice to have: knowledge of clinical trial and licensing requirements
Nice to have: experience in immunology & inflammation
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