Global Regulatory Strategy Director: Submissions Lead
Exelixis Inc
Exelixis Inc in Alameda, CA is seeking a Regulatory Affairs leader to develop and implement global regulatory strategies that align with asset and corporate goals and health authority requirements. You will ensure timely preparation of organized, scientifically valid submissions and communicate regulatory plans to stakeholders to mitigate risk. The role requires a high degree of regulatory expertise, leadership in cross-functional teams, and the ability to manage multiple development programs #J-18808-Ljbffr Exelixis Inc
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Global Regulatory Strategy Director: Submissions Lead in Alameda, CA vacancy
- ...heart and lung disease - the leading causes of death globally. Our FDA cleared, industry... ...globally by leading regulatory strategy across the full product lifecycle. The Director owns the overall regulatory... ...drives highly coordinated submissions and approvals (FDA, CE Mark...SuggestedWork at office
- ...Inc. seeks an Executive Director, Regulatory Affairs to oversee global regulatory activities from... ...- approval, developing strategies across clinical, non-... ...disciplines. This role leads the regulatory program team... ...ensuring timely, high-quality submissions and effective agency...Suggested
- Ray Therapeutics, Inc. is seeking a Director of Regulatory Affairs to lead global regulatory strategy for clinical programs. Reporting to the Chief Regulatory Officer... ...teams to ensure compliance and timely submissions. This role requires 10-12+ years in biotech/pharma...Suggested
$195k - $277.5k
...the development and implementation of global regulatory strategies that align with asset and corporate... ...consistent, and scientifically valid submissions. Provides expertise in translating regulatory... ...work instructions and company SOPs. Lead multiple assets and/or studies as...SuggestedFull timeWork at officeLocal areaFlexible hours- Exelixis is seeking a Senior Regulatory Affairs role in California to develop and implement global regulatory strategies that align with asset and... ...preparation of organized submissions and translate regulatory... ...interact with authorities, lead cross-functional teams, review...Suggested
- Exelixis, Inc. in Alameda, CA is seeking an Assoc Regulatory Affairs Strategy Director (Oncology) to lead global regulatory strategies, ensure timely submissions, and guide study teams. The role requires senior-level expertise in regulatory affairs and collaboration with...
- Eko is seeking a Director of Regulatory Affairs to lead global strategy for SaMD and hardware. You will own FDA/CE/Health Canada submissions, shape regulatory pathways, and partner with R&D, Quality, and Commercial teams to accelerate compliant market access. You will build...
- Epia Neuro in Alameda, CA is seeking a Director of Regulatory Affairs to lead and execute regulatory strategy for Class III implantable neurotechnology. You will report... ...from early FDA engagement through IDEs and PMA submission. This role requires deep FDA knowledge, ISO...
$268.5k - $380k
...JOB PURPOSE:The Executive Director, Regulatory Affairs has oversight for... ...and implementing global regulatory strategies encompassing clinical, non... ...and scientifically valid submissions. Provides expertise in translating... ...Has extensive experience leading multiple projects...Full timeContract workWork at officeLocal areaFlexible hours- Exelixis seeks an Associate Regulatory Operations Director to oversee submission activity for our global portfolio, ensuring staffing and timely filings. The role requires deep knowledge of regulatory submission requirements and collaboration across Regulatory Affairs...
$157.5k - $222.5k
...Alameda, California, is looking for an Associate Regulatory Operations Director to oversee regulatory submission activities and ensure effective collaboration within... .... This position requires extensive knowledge of global regulatory requirements and involves managing...- Exelixis, Inc. is seeking an Associate Regulatory Operations Director in Alameda, CA. This role is responsible for overseeing submission activities and managing the submission forecast. The ideal candidate will have substantial experience in regulatory operations and will...
- Exelixis Inc. seeks a senior leader to drive recruitment and retention governance for informed consent across global clinical trials. You will align policy with external regulations and collaborate with CROs, vendors, and site teams to meet enrollment goals. You will guide...
- Itlearn360 is seeking an Associate Director, Search Engine Marketing &... ...Emeryville, CA. This role involves leading SEO and SEM initiatives, managing global PPC campaigns, and analyzing performance... ...skills, capable of developing strategies for optimization. #J-18808-...
$172k - $245k
...is seeking a Senior Clinical Trials Manager to manage and lead the execution of clinical trials in Alameda, California. This... ...requires expertise in clinical operations, overseeing global study delivery strategies, and maintaining compliance with ICH/GCP guidelines. The ideal...- Abbott, a global healthcare leader, invites you to join the Capital Procurement team in Alameda... ...equipment expansion, develop category strategy, manage SRM, and collaborate with... ...offers travel up to 20% and opportunities to lead international negotiations. A Bachelor's...
- ...Exelixis, Inc. is seeking an Exec Medical Director for Pharmacovigilance Risk Management in Alameda, CA. This role is responsible for leading the development and execution of global product safety strategies for oncology products, overseeing safety analyses, and engaging...
- ...Exelixis Inc is looking for an Executive Medical Director based in California to oversee the global product safety strategy for oncology products. This role requires extensive experience in pharmacovigilance and clinical development, along with strong leadership skills...
$164.5k - $234.5k
...recruitment and retention strategy while ensuring adherence to global requirements and... ...forms and clinical trials. Leads a cross-functional governance... ...informed consent global submissions to integrate into... ...trials.Knowledge of GCP and regulatory requirements related to...Full timeWork at officeLocal areaWorldwideFlexible hours- Abbott is seeking a senior portfolio leader to drive the Global Strategic Initiatives PMO. You will own governance, prioritization, and... ...tools, and marketing roadmaps. You will partner with BTS/IT, Regulatory, Quality, and Commercial teams to ensure alignment with strategic...
- Farasis Energy USA in Hayward, CA, is hiring an IT Manager to create and implement technology strategies that enhance global collaboration and efficiency. The ideal candidate will have a Bachelor’s degree in Computer Science and at least 5 years of experience in IT management...Remote work
$157.5k - $222.5k
...PURPOSE: The Associate Regulatory Operations Director is responsible for overseeing submission activity for the... ...in-depth knowledge of global regulatory submission... ...impact due to changes in strategy and/or timelines are assessed... ...and management. Leads a cross-functional team...Full timeWork at officeLocal areaFlexible hours$248k - $352.5k
...the development and implementation of global regulatory strategies that align with asset and corporate... ...consistent, and scientifically valid submissions. Provides expertise in translating regulatory... ...objectives and regulatory strategy. Lead, author and evaluate documents...Full timeContract workWork at officeLocal areaFlexible hours$114k - $228k
...Full timeAbbott is a global healthcare leader that... ...spectrum of healthcare, with leading businesses and... ...sensing technology. This Regulatory Affairs Manager... ...talent, shape regulatory strategy, and partner across functions... ...on FDA pathways, submissions, and interactions, including...Shift work$114k - $228k
...Full timeAbbott is a global healthcare leader that... ...spectrum of healthcare, with leading businesses and... ....The Opportunity This Regulatory Affairs Manager - APAC... ...robust global regulatory strategies, working with cross-... ...compiling regulatory submissions, and ensuring data is...Shift work$168.9k - $281.7k
...creating software trusted by over 90% of leading industrial companies.Salary Range:$168,... ...educational attainment and/or training.Director, Global Practice Lead — PI Data Infrastructure... ...practice worldwide. You will lead the strategy, the teams, and the emerging industry enablement...Full timeWork at officeLocal areaRemote workWorldwideFlexible hours- ...Role We’re looking for a Director of Regulatory Affairs for our office... ...who wants to lead, develop and execute the regulatory strategy for Epia Neuro’s Class... ...through IDEs and PMA submission and approval, and commercialization... .... Define and own the global regulatory strategy,...Full timeWork at office3 days per week
Epia Neuro
Alameda, CA4 days ago $115k - $130k
...Job Description: Director of Regulatory Affairs and Policy... ...social impact alongside leading experts in engineering... ...and regulatory affairs strategy for the Oakport Project... ..., and related submissions prepared by third-party... ...Through partnerships with global supply chains and...Work at officeLocal areaRemote work3 days per weekSupplyBank.org
Oakland, CA1 day ago$114k - $228k
Abbott Laboratories is looking for a Manager of Public Affairs to lead the global public relations strategy for its diabetes business in Alameda, California. The candidate should have over six years of relevant experience, excelling in media relations, content development...$100k - $200k
Abbott is a global healthcare leader that helps people live more... ...spectrum of healthcare, with leading businesses and products in diagnostics... ...that influence business strategy, and present compelling... ..., and high-quality financial submissions, serving as a trusted source...Work experience placementWorldwide
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Regulatory Strategy Director: Submissions Lead. Be the first to apply!
Related searches
- director global regulatory affairs Alameda, CA
- regulatory manager Alameda, CA
- manager regulatory affairs Alameda, CA
- regulatory & compliance manager Alameda, CA
- head compliance Alameda, CA
- regulatory affairs director Alameda, CA
- compliance director Alameda, CA
- compliance manager Alameda, CA
- corporate planning manager Alameda, CA
- planning manager Alameda, CA