Top Regulatory Affairs Executive jobs in San Jose, CA
Top Regulatory Affairs Executive oversees all regulatory matters and creates the overall strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Top Regulatory Affairs Executive establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Top Regulatory Affairs Executive investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to top management. The Top Regulatory Affairs Executive manages a business unit, division, or corporate function with major organizational impact. Establishes overall direction and strategic initiatives for the given major function or line of business. Has acquired the business acumen and leadership experience to become a top function or division head. (Copyright 2024 Salary.com)
Recently Added Top Regulatory Affairs Executive jobs
Executive Director, Regulatory Affairs CMC
- Allakos
-
Redwood, CA
FULL_TIME
-
Exec Director Regulatory Affairs/CMCAllakos Inc. is a dynamic clinical-stage biopharmaceutical company developing first-in-class antibody-based therapeutics to treat allergic and inflammatory diseases.
The Executive Director, CMC Regulatory Affairs is responsible for developing and directing the regulatory CMC strategy, objectives, and programs pertaining to development and marketing of drug products.
They will:- Lead teams with regulatory CMC responsibility for support of development, registration and life cycle support, and CMC regulatory strategy for United States and EU.
- Partner with regulatory support functions
- Partner with Quality, Manufacturing, Process Development, and Supply Chain
- Be the key interface between the Regulatory and the Technical Operations functions.
Responsibilities:- Creates and implements CMC regulatory strategies for CTA submissions and marketing applications. This role will have accountability for regulatory CMC as well as represents regulatory on key internal decision making teams. This role may oversee the work of junior CMC regulatory staff.
- Proactively partners with Technical Operations counterparts on processes and program prioritization.
- Proactively partners with the Head of Regulatory on the development of the regulatory strategy .
- Functions as the regulatory CMC lead , working with other Regulatory colleagues to drive regulatory strategies.
- Provides proactive guidance to internal groups (Quality, Manufacturing, etc) based on technical and CMC regulatory knowledge towards development of strategic and tactical plans. Identify and assess regulatory risks associated with assigned projects.
- Leads the development of strategic CMC plans and tactical implementation for the creation and submission of Regulatory documents, e.g., INDs, BLAs, CTAs, MAAs, and other relevant regulatory filings
- Serves as corporate liaison for CMC with regulatory Health Authority (HA) to develop effective professional relationships as well as a positive company image.
- Effectively leads key CMC focused meetings with HAs to ensure full discussion of issues and opportunities.
- Provides guidance to all appropriate departments to assure compliance with applicable regulations.
- Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel and works with regulatory policy/intel as appropriate.
- Makes recommendations for regulatory department operating procedures. May be responsible for creating and reviewing SOPs as needed.
- Leads and/or participates in regulatory and technical operation initiatives to improve processes and ways of working, keeping currently with approaches to regulatory strategy and submissions.
- Actively trains/mentors junior staff; provides broader guidance on regulatory interpretation to staff inside and outside Regulatory Affairs
- May supervise Regulatory Affairs team members.
Qualifications and Expertise:- BS, BSc, MS, MSc, PhD, PharmD, in science or healthcare preferred or equivalent relevant experience.
- 15 years of Regulatory CMC experience as well as additional experience in the biopharmaceutical industry in other areas. The regulatory experience should be broad (across the life cycle of pharmaceutical products and across main regions such as US, EU, Japan and Canada) to ensure appropriate leadership and mentoring for regulatory staff.
- Successfully prepared and filed a BLA, preferably for a monoclonal antibody or therapeutic protein,
- 5 years of management experience preferred
The salary is competitive and commensurate with experience and qualifications.Allakos is an equal opportunity employer. Allakos will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. - 8 Days Ago
Director, Clinical Regulatory Affairs
- Cymabay Therapeutics
-
Newark, CA
FULL_TIME
- Summary:The Director of Regulatory Affairs will support the development and implementation of regulatory strategies for pipeline programs. The Director will provide strategic and operational leadershi...
- 16 Days Ago
Director of Regulatory Affairs
- Imperative Care Inc
-
Campbell, CA
FULL_TIME
- SUMMARY: Manage day to day activities for Regulatory Affairs function. Partner with internal departments and external consultants to efficiently deliver accurate, timely, and effective regulatory docu...
- 21 Days Ago
Regulatory Affairs specialist
- Katalyst Healthcares & Life Sciences
-
Santa Clara, CA
CONTRACTOR
- Responsibilities: Participate on project teams as regulatory or as RA/QA/CA representative. Develop plans to receive approvals to sell products identified in the marketing sales plan. Maintain knowled...
- 21 Days Ago
Principal Regulatory Affairs Specialist
- Imperative Care Inc
-
Campbell, CA
FULL_TIME
- SUMMARY: Partner with Truvic's functional groups to efficiently deliver accurate, timely, and effective regulatory strategies, documents, deliverables and other projects in line with company objective...
- 21 Days Ago
Regulatory Affairs Specialist II
- Katalyst Healthcares & Life Sciences
-
Redwood City, CA
FULL_TIME
- Responsibilities: You are responsible for regulatory submissions and regulatory compliance for currently marketed products, as necessary, to ensure ongoing compliance Regulatory representative on core...
- 21 Days Ago
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0 Top Regulatory Affairs Executive jobs found in San Jose, CA area
Regulatory Affairs Specialist – Digital Health Technologies
- Abbott
-
Alameda, CA
- Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-chan...
- 4/24/2024 12:00:00 AM
Regulatory Affairs Specialist
- GForce Life Sciences
-
Santa Clara, CA
- Regulatory Affairs Specialist– Santa Clara, CA Must be able to work on a W2 Job Summary: We are seeking a regulatory aff...
- 4/23/2024 12:00:00 AM
Principal Regulatory Affairs Specialist
- Planet Pharma
-
Palo Alto, CA
- Responsibilities and Duties: Acts as technical regulatory lead on core product development teams, communicates regulator...
- 4/23/2024 12:00:00 AM
Regulatory Affairs Specialist
- GForce Life Sciences
-
Santa Clara, CA
- Regulatory Affairs Specialist II – Santa Clara, CA Must be able to work on a W2 Job Summary We're looking for a Regulato...
- 4/22/2024 12:00:00 AM
Regulatory Affairs Specialist II – Heart Failure
- Abbott Laboratories
-
Pleasanton, CA
- Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-chan...
- 4/22/2024 12:00:00 AM
Regulatory Affairs Specialist - Digital Health Technologies
- Abbott
-
Alameda, CA
- Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-chan...
- 4/22/2024 12:00:00 AM
Principal Regulatory Affairs Specialist
- Planet Pharma
-
Palo Alto, CA
- Responsibilities and Duties: Acts as technical regulatory lead on core product development teams, communicates regulator...
- 4/21/2024 12:00:00 AM
Regulatory Affairs Specialist – Digital Health Technologies
- Abbott Laboratories
-
Alameda, CA
- Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-chan...
- 4/5/2024 12:00:00 AM
About San Jose, California
San Jose is located at 37°20′07″N 121°53′31″W / 37.335278°N 121.891944°W / 37.335278; -121.891944. According to the United States Census Bureau, the city has a total area of 180.0 sq mi (466 km2), of which 3.4 sq mi (8.8 km2) (1.91%) is water, making it the fourth-largest California city by land area (after Los Angeles, San Diego and California City).
San Jose lies between the San Andreas Fault, the source of the 1989 Loma Prieta earthquake, and the Calaveras Fault. San Jose is shaken by moderate earthquakes on average one or two times a year. These quakes originate just east of the city on...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Top Regulatory Affairs Executive jobs
$367,613 to $601,425
San Jose, California area prices
were up 2.9% from a year ago
were up 2.9% from a year ago
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