- Provide strategic and operational regulatory support for Chemistry, Manufacturing, and Controls (CMC) collaboration within project teams.
- Planning, coordinating, and developing CMC sections for regulatory submissions, reviewing protocols and reports, and ensuring compliance with regulations.
- Offering regulatory advice to cross-functional teams, leading the drafting of submission responses to regulatory queries, and collaborating with CMC and Quality departments for Scale-up and Post-Approval Changes.
- Contribute to regulatory plans, strategies, and risk mitigation is expected.
- Life Sciences Degree (MSc, MPH, PhD - preferred)
- 7-10yrs of direct Pharmaceutical experience within Regulatory Affairs
- IND through Late Stage development required
- Hands on NDA experience
- Successful regulatory submissions to FDA
-
Director/Sr. Director of Sales
13 hours ago
Menlo Micro California, United StatesTitle: Director/ Sr. Director of Sales & Business Development, Americas · Reports To: Vice President, WW Sales & Business Development · Remote office location with willingness to commute to Irvine, California (when required) · About Us: · Menlo Micro has reinvented one of the mos ...
-
Director/ Sr. Director, Strategy
1 week ago
EMPIRE California, United StatesSr. Director or Director, Strategy and Data Analytics · EMPIRE is a premier and dynamic music company that prides itself on the development and support of independent artists. We are a rapidly growing firm that has been making waves in the music industry, with an extensive portfo ...
-
Sr Medical Director/Medical Director
4 weeks ago
Meet California, United StatesMeet has partnered with a biotech that is at the forefront of research and development in cortisol modulation, pioneering molecules that regulate cortisol activity at the glucocorticoid receptor (GR). They are seeking a Sr Medical Director/Medical Director to play a pivotal role ...
-
Sr. Director, Product Management
1 week ago
Infinera California, United States Full timeCA Pay Range (Annual): · $206, $383,500.00 Non-CA Pay Range (Annual): · $185, $345,200.00 At Infinera, your base pay is one part of your total compensation package. Your actual base pay will depend on your skills, qualifications, experience, and location. This role may be eligibl ...
-
Director
2 weeks ago
Flight Crew International California, United StatesThe Director of Operations is a senior leadership role responsible for overseeing and managing all · aspects of flight operations for our FAA 121 operations and maintains the FAA 119 certificate. This · includes developing and implementing strategies, policies, and procedures to ...
-
Director
1 week ago
FIFTEEN WEST California, United StatesJob Title: Director of Recruitment (HR) · Salary: $150k+ DOE · Location: San Francisco, CA (Hybrid) · My client, established in 2005, is a premier HR recruitment specialist with a strong presence in both the UK and the US. Our client base spans across Financial Services, Not-fo ...
-
Director of IT
1 week ago
Wisner Baum California, United StatesAbout This Job · Are you passionate about technology? Do you thrive on your ability to use technology to protect a firm and improve its operational efficiency? Does leading a team inspire you? Do you thrive on the idea of working for a law firm celebrated for its victories agains ...
-
Technical Director
1 week ago
Radiant Innovations Superior, United StatesSuperior '100% Team Spirit - 453 Employees - 420 Beds for Inpatient Care per Year - 7 Sister Clinics My Team, My Path The m&i Specialist Clinic is nestled in the beautiful natural landscape of the Upper Bavarian foothills between Lake Starnberg and Lake Tegernsee. Our collaborati ...
-
Sr. Director of GTM Strategy and Execution
2 weeks ago
Adobe California, United States Full timeOur Company · Changing the world through digital experiences is what Adobe's all about. We give everyone—from emerging artists to global brands—everything they need to design and deliver exceptional digital experiences We're passionate about empowering people to create beautiful ...
-
Associate Director/Director, Biology
3 weeks ago
Firefly Bio California, United StatesAbout Firefly Bio: · Firefly specializes in Degrader Antibody Conjugates (DACs) which combine the unique strengths of ADCs with selective protein degraders. Our state-of-the-art platform results in highly specific delivery of degraders to target tissue. Our mission is to realize ...
-
Sr. Art Director, Fun Brand
4 weeks ago
24 Seven Talent California, United StatesOur client, a beauty and wellness brand , is looking for an Art Director who work with creative director and marketing teams to concept and execute 360 strategies. Candidates should have experience working from concept to execution. · Hybrid – El Segundo, CA · Art Director /Sr. A ...
-
Medical Director- Executive Medical Director
2 weeks ago
SciPro California, United StatesDirector-Executive Medical Director, Clinical Development, San Diego · I am currently searching for a Clinical Development Director (title ranging from Director to Executive Director), for a Cardiovascular development program in a mid size Rare Disease Organization. · The Clinica ...
-
Development Director
1 week ago
Community Water Center California, United StatesLocation: CWC currently has offices in Sacramento, Visalia and Watsonville, CA. CWC believes our mission can be effectively advanced while being flexible in our approach to work style and location. We prefer candidates for this position to be able to work in-person at least two d ...
-
Director of Nursing
2 weeks ago
SimiTree California, United StatesDirector of Nursing - Home Health · If you are an experienced Executive Director, Director of Operations, Administrator, Director of Nursing / DON, Director of Patient Care Services / DOPCS, or Director of Clinical Services / DOCS, Clinical Manager, Clinical Supervisor, or Pati ...
-
Director of Engineering
3 weeks ago
EVONA California, United StatesDirector of Engineering - Los Angeles · We are on the lookout for a Director of Engineering / Chief Engineer to join a rapidly growing Spacecraft development organization based in Los Angeles. · Job Summary: · As the director of engineering, you will be the cornerstone of the En ...
-
Development Director
4 weeks ago
Samuel Knight International California, United StatesJob Title: Renewable Energy Development Director/ Senior Director · Department: Renewable Energy Development · Reports to: Regional Vice President · Location: California/Nevada · Renumeration: $148K - $220K/y · About Our Client: · Our client is a leading independent power produ ...
-
Director of Engineering
13 hours ago
Henderson Scott California, United StatesRole: Director of Engineering (HealthTech) · Location: San Diego, CA (Remote/Hybrid) · Salary: $200k + 401k + Health Cover · Our client who we're founded in 2013 are going through an exciting growth phase. They're looking to recruit a Director of Engineering to report into the ...
-
Director/Senior Director Analytical Development
3 weeks ago
Barrington James California, United StatesDirector/Senior Director of Analytical Development · (CA, hybrid or remote with frequent travel) · I've got a great opportunity to join a pioneering biotech company at the forefront of innovative biologics development, specializing in antibodies for infectious and rare diseases ...
-
Director of Facilities
1 week ago
DSJ Global California, United StatesDirector of Facilities · Join Our Mission to Protect Humankind · A clinical-stage vaccine innovation company is dedicated to engineering high-fidelity vaccines to combat serious and costly bacterial diseases. Our goal is to eradicate or treat infections such as invasive pneumococ ...
-
Design Director
3 weeks ago
BGSF California, United StatesReporting to the Vice President of Brand & Creative, the Design Director leads (but does not people-manage) the design work streams of the design team, as they deliver high-bar creative assets for marketing campaigns, collateral, email, event signage, swag, and more. They collabo ...
Director/Sr. Director - California, United States - Meet
Description
My client is a clinical-stage biopharmaceutical company focused on developing innovative therapies for rare diseases. They are currently seeking a skilled regulatory professional to join their growing team as Director/ Sr. Director CMC Regulatory Affairs. This role will involve hands-on development and implementation of regulatory strategies for CMC aspects of their rare disease development programs, working closely with other departments. Will be onsite in the Bay Area 3x per week.
Responsibilities:
Qualifications:
Send a copy of your updated resume to to learn further details