Regulatory Affairs Manager
Katalyst HealthCares & Life Sciences
Job Title
Responsibilities:
Regulatory submissions including Original ANDAs, Amendments, Annual Reports, Supplements and PADERs to company applications.
Preparation/Review of Original submission/Amendments/ Supplements as assigned by the Director, Regulatory Affairs or VP, Regulatory Affairs.
Participate in project calls with minimal supervision and work very closely with internal and external project managers, contract manufacturers to ensure timely availability of documents for submission.
Review the submission documents for accuracy and adequacy and approach the management immediately for any questions or concerns.
Stay updated on the Agency's expectations based on guidance's/ deficiencies and apply the same logic for future submissions to avoid any similar deficiencies.
Ensure the facilities used in company's applications commit to GDUFA requirements (site identification, facility fees).
Requirements:
Degree in Science with at least 10 years of experience in the pharmaceutical industry.
Understanding of regulations relating to generic pharmaceuticals.
Understanding of generic drug approval process and associate regulations.
Capable of technical review of documents submitted in applications.
Organizational skills and multi-tasking.
Excellent written and verbal communication skills.
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Regulatory Affairs Manager in San Jose, CA vacancy
$120k - $145k
...The Regulatory Affairs Manager is responsible for monitoring, interpreting, and influencing regulatory and standards requirements that impact HVAC products and systems within the West Coast region, primarily California. This role will lead the company's state legislative...SuggestedContract workWork experience placementWork at officeDaikin
Santa Clara, CA1 day ago- ...Job Summary This Regulatory Affairs Manager position is an onsite opportunity. The candidate will combine knowledge of scientific, regulatory, and business issues to enable products, including combination products, that are developed, manufactured or distributed...SuggestedWork experience placement
Gateway Recruiting
San Jose, CA3 days ago - ...system generates data that must be stored, managed, and made accessible over time. That’s... ...in alignment with legal requirements, regulatory expectations, and the company’s values.\... ...n Internal Communications.\n Government Affairs.\n Business and regional leadership.\n\nServe...SuggestedWork at officeWorldwideShift work
Western Digital
San Jose, CAa month ago - ...technology, data, and AI to enhance surveillance, testing, and issue management while ensuring that human judgment remains central to the... ...that extends to enterprise-wide privacy, cybersecurity, and regulatory change. Applicants must have at least 12 years' of progressive...Suggested
- ...effectively, consistently, and in alignment with legal requirements, regulatory expectations, and the company's values. This executive will be... ...including but not limited to, compliance operations, program management, ethics reporting, investigations, anti-corruption compliance,...Suggested
- ...This executive oversees the day-to-day management of core compliance functions, ensuring that... ...in alignment with legal requirements, regulatory expectations, and the company's values.... ...Internal Communications. Government Affairs. Business and regional leadership....
- ...overseeing the implementation of the U.S. compliance regime, managing the compliance technology suite, maintaining annual corporate... ..., and ensuring that all products and services comply with the regulatory landscape. Applicants for the Chief Compliance Officer position...
- ...candidate will be responsible for leading and maintaining the firm's regulatory compliance program, serving as the primary liaison for... ...with federal and state regulatory requirements, as well as the management of tax reporting and withholding compliance. The Head of Compliance...
- ...lifecycle. The CCO will also be tasked with owning and improving key commercial metrics, building a scalable commercial structure, and managing a team to ensure the efficiency of the commercial funnel. Applicants for the CCO position at the company should have a minimum of...
- ...a pivotal role in the development and execution of legal and regulatory strategies. The successful candidate will be responsible for leading... ...team, involved in negotiating commercial agreements, managing vendor relationships, and building a robust compliance program...
- ...company. Essential experience includes personally carrying and hitting a direct quota on enterprise deals with large health systems, managing through at least one layer, and having a strong background in the full sales cycle. The ideal candidate will be a player-coach,...
- ...market share, and ensuring that all organizational activities are in line with strategic commercial goals. This role involves direct management of commercial revenue planning, maintaining global systems and procedures, and overseeing commercial reporting and dashboards....
- ...mentality, with the CCO expected to be a key player in the sales process while also leading and developing the sales team. Experience in managing through at least one layer and a strong background in hiring, coaching, and transitioning sales talent are essential. The...
- ...company's growth and must be adept at working in a fast-paced, dynamic environment, with a focus on preparing the business for a future private equity exit. Hiring Manager Title CEO Functions Marketing Sales/Revenue Business Development Confidential
- ...organizations. Strong strategic and financial acumen, including expertise in pricing strategy, revenue optimization, and margin management, is essential. The successful CCO will be a key player in shaping the company's growth strategy and future direction, and as such...
- ...unified, scalable commercial organization, and requires a hands-on, data-driven approach to sales leadership, pricing, and margin management. The CCO will also be instrumental in M&A integration, leading commercial diligence on acquisition targets and ensuring a...For contractorsFor subcontractor
- ...the compliance function, serve as a key advisor to the Chief Risk Officer, and oversee all aspects of compliance, including managing regulatory exams, audits, and reporting. The role also involves collaborating with various teams to identify and manage compliance risks...
$165.18k - $247.5k
...across HR, Finance, Marketing, Legal, Compliance, and Workplace Management. Led by the Senior Director of Enterprise Applications, the... ...management, contract lifecycle management (CLM), e-billing, and regulatory compliance platforms.Ensure applications meet audit, data...Permanent employmentContract workInternshipWork at officeWork from homeMarvell
Santa Clara, CA3 days ago- ...Job Title Director of Regulatory Affairs | Requisition ID req1179 Type of Employment Regular Full-Time Employee... ...Distinguishing Features: This position is distinguished by management level responsibility for regulatory affairs and by the performance...Full time
Connecticut Water
San Jose, CA4 days ago $346.64k
...of the patients across the world. As the Global Head of Regulatory Affairs, you enable and empower your team to deliver on our vision through... ...Monitors the global regulatory environments, and provides management with assessments of the impact of new and changing...Full timeLocal areaRelocation package$105k - $120k
...Summary A direct hire opportunity is available for a Compliance Manager in San Jose, CA within the healthcare services industry. This... ..., claims processes, and business practices align with regulatory requirements, accreditation standards, ethical expectations, and...Temporary workWork at office- ...Executive Director, Regulatory Affairs About the Company Esteemed company developing medicines for inflammatory & autoimmune diseases... ...rigor, regulatory compliance, and commercial impact. Hiring Manager Title SVP, Chief Regulatory Officer Functions Legal...
$90k - $100k
...organization in Milpitas, CA is seeking an experienced Compliance Manager for a direct hire opportunity. This role is ideal for a... ...leadership and operational teams. The Compliance Manager will oversee regulatory compliance, claims management, policy development, audits,...Temporary workWork at office$130k - $175k
...production. Join us to help create the displays that will power the future of immersive computing. Description We are seeking a Manager, Contracts & Compliance to support commercial contracting, compliance activities, and business operations across the company. This...Contract workInlighten Technologies
Santa Clara, CAa month ago- ...Risk & Compliance Officer, the Compliance Manager is responsible for the administration... ...investigations, corrective action management, and regulatory compliance tracking. The Compliance... ..., quality improvement, regulatory affairs, grants compliance, contract compliance,...Contract workWork experience placementWork at officeLocal area
- ...Job Description Job Description Overall Summary: Compliance Manager is responsible for ensuring policies and procedures comply with regulatory and ethical standards of the organizations comply accreditation standards by implementing and administering practices,...Work at office
Bay Area Community Health
San Jose, CAa month ago - ...Administration LOCATION: San Jose, CA (onsite) Summary: Company X seeks an experienced grants administrator to oversee the management, budgeting, and compliance of $8+ million in federal, state, and local grants and contracts. Reporting to the Vice President of...Contract workFor subcontractorLocal area
The Rockridge Group
San Jose, CAa month ago - Director of Regulatory Affairs Supporting innovative endoscopy and diagnostics technologies Onsite/hybrid : Bay Area ( San Jose ) Reports... ...submission of regulatory documentation and reports. Utilize project management skills to plan, execute, and monitor regulatory projects....
- ...Job Description Job Description Job Description Primary Function of Position: As a Regulatory Affairs Manager/Director-your primary function will be to prepare regulatory FDA submissions for products including pre-submissions. You will work closely with cross...Permanent employmentContract workTemporary workWork experience placement
W3Global Inc.
Saratoga, CA3 days ago - ...leading the compliance strategy to ensure the highest standards of regulatory and product integrity as the company expands its market... ...Head of Compliance will also be involved in incident response, managing internal investigations, and coaching the compliance team to promote...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Affairs Manager. Be the first to apply!
Related searches
- manager regulatory affairs San Jose, CA
- head compliance San Jose, CA
- compliance manager San Jose, CA
- regulatory affairs director San Jose, CA
- director global regulatory affairs San Jose, CA
- compliance director San Jose, CA
- regulatory & compliance manager San Jose, CA
- regulatory manager San Jose, CA
- regulatory accountant San Jose, CA
- regulatory law San Jose, CA