Current jobs related to Associate Director, Global Regulatory Science, CMC - Cambridge - Moderna Theraputics
-
Associate Director, Regulatory CMC
4 months ago
Cambridge, United States Intellia Therapeutics Full timeWhy Join Intellia?Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to...
-
Director, Regulatory Affairs CMC
7 days ago
Cambridge, Massachusetts, United States Takeda Full timeRegulatory Affairs Director, Small MoleculesTakeda is seeking a highly experienced Regulatory Affairs Director, Small Molecules to lead our Global Regulatory Affairs CMC team. As a key member of our team, you will be responsible for overseeing the development and execution of regulatory CMC development and registration strategies.Key Responsibilities:Plan,...
-
Senior Manager, CMC Regulatory Expert
3 hours ago
Cambridge, Massachusetts, United States Relay Therapeutics Full timeThe OpportunityWe are seeking a highly skilled Senior Manager, CMC Regulatory to join our Pharmaceutical Development team. As a key member of our team, you will play a critical role in regulatory strategy development and execution of assigned Chemistry, Manufacturing and Control (CMC) programs.This position requires weekly onsite presence and involves...
-
Cambridge, Massachusetts, United States Takeda Full timePosition OverviewAt Takeda, we are committed to pioneering advancements in research and development that lead to transformative therapies for patients. Our focus on four key therapeutic areas, along with targeted investments, allows us to redefine the possibilities in delivering life-altering treatments globally.As the Senior Director of Regulatory Affairs...
-
Director, Global Regulatory Affairs
2 weeks ago
Cambridge, Massachusetts, United States GlaxoSmithKline Full timeAbout the RoleWe are seeking a highly skilled and experienced Regulatory Affairs Director to join our team at GlaxoSmithKline. As a key member of our Global Regulatory Affairs team, you will play a critical role in shaping our regulatory strategy and ensuring compliance with regulatory requirements.Key ResponsibilitiesDevelop and implement regulatory...
-
Director, GRA CMC Small Molecules
3 weeks ago
cambridge, United States Takeda Full timeJoin Takeda as a Director, GRA CMC Small Molecules where you will oversee the development and execution of regulatory CMC development and registration strategies. RA CMC member on Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff. Demonstrate high...
-
Director, GRA CMC Small Molecules
3 weeks ago
Cambridge, United States Takeda Full timeJoin Takeda as a Director, GRA CMC Small Molecules where you will oversee the development and execution of regulatory CMC development and registration strategies. RA CMC member on Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff. Demonstrate high...
-
Director, GRA CMC Small Molecules
3 weeks ago
Cambridge, United States Takeda Full timeJoin Takeda as a Director, GRA CMC Small Molecules where you will oversee the development and execution of regulatory CMC development and registration strategies. RA CMC member on Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff. Demonstrate high...
-
Senior Manager, CMC Facilities Regulatory Affairs
4 months ago
Cambridge, United States 9627 Corixa Corporation Full timeAt GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong...
-
Cambridge, Massachusetts, United States 9627 Corixa Corporation Full timeJob SummaryWe are seeking a highly skilled Senior Manager, CMC Facilities Regulatory Affairs to join our team. This role will be responsible for regulatory submissions, interactions with FDA, and strategy for various US vaccines regarding manufacturing facilities and equipment aspects.Key Responsibilities:Act as the legal agent for CMC Facility specific...
-
CMC Submissions Lead
1 week ago
Cambridge, Massachusetts, United States Takeda Manufacturing USA, Inc Full timeAbout the RoleTakeda Manufacturing USA, Inc. is seeking a highly skilled professional to lead the Global Chemistry, Manufacturing and Control (CMC) Submissions Team. As a key member of our organization, you will be responsible for overseeing the development and submission of regulatory documents for all countries, including:Development submissions...
-
Senior Director of CMC Technical Innovation
1 week ago
Cambridge, Massachusetts, United States Proclinical Staffing Full timeSenior Director CMC Technical InnovationProclinical is seeking a seasoned professional to lead our CMC Technical Innovation team in Gene Therapies. This role requires a unique blend of technical expertise, effective communication, and business acumen.Key Responsibilities:Develop and implement a centralized innovation framework to drive technical advancements...
-
Global Regulatory Labeling Director
2 weeks ago
Cambridge, Massachusetts, United States Proclinical Staffing Full timeJob Summary:Proclinical Staffing is seeking a highly experienced Director, Global Regulatory Labeling to join our team. As a key member of our organization, you will be responsible for developing and executing regulatory labeling strategies for our global biotech clients.Key Responsibilities:Regulatory Labeling Strategy: Develop and maintain current...
-
Senior Director CMC Technical Innovation
2 weeks ago
Cambridge, United States Proclinical Staffing Full timeSenior Director CMC Technical Innovation - Gene Therapies - Permanent - Massachusetts Proclinical is seeking a Senior Director of CMC Technical Innovation to focus on Gene Therapy. This role requires a combination of CMC technical expertise (e.g. gene therapy, RNA, gene editing), effective communication, business and strategic acumen. Primary...
-
Senior CMC Development Director
3 weeks ago
Cambridge, Massachusetts, United States MEDIPOST America, Inc. Full timeMEDIPOST America, Inc. is a prominent umbilical cord blood banking and cellular therapy organization, dedicated to pioneering innovative stem cell treatments for degenerative conditions such as Alzheimer's disease, Diabetic Neuropathy, and Osteoarthritis.Our flagship product, CARTISTEM, represents the first stem cell therapy globally approved for knee...
-
Regulatory Affairs Manager
3 weeks ago
Cambridge, Massachusetts, United States Biogen Full timeJob SummaryWe are seeking a highly experienced Regulatory CMC Team Lead to lead our small molecules portfolio. As a key member of our Regulatory CMC team, you will be responsible for defining regulatory CMC strategy, planning, and preparation of global CMC regulatory submissions to achieve timely approvals of clinical trial applications, initial marketing...
-
Senior Director CMC Technical Innovation
2 weeks ago
cambridge, United States Proclinical Staffing Full timeSenior Director CMC Technical Innovation - Gene Therapies - Permanent - Massachusetts Proclinical is seeking a Senior Director of CMC Technical Innovation to focus on Gene Therapy. This role requires a combination of CMC technical expertise (e.g. gene therapy, RNA, gene editing), effective communication, business and strategic acumen. Primary...
-
Senior Director CMC Technical Innovation
2 weeks ago
cambridge, United States Proclinical Staffing Full timeSenior Director CMC Technical Innovation - Gene Therapies - Permanent - Massachusetts Proclinical is seeking a Senior Director of CMC Technical Innovation to focus on Gene Therapy. This role requires a combination of CMC technical expertise (e.g. gene therapy, RNA, gene editing), effective communication, business and strategic acumen. Primary...
-
Senior Director CMC Technical Innovation
2 weeks ago
Cambridge, United States Proclinical Staffing Full timeSenior Director CMC Technical Innovation - Gene Therapies - Permanent - Massachusetts Proclinical is seeking a Senior Director of CMC Technical Innovation to focus on Gene Therapy. This role requires a combination of CMC technical expertise (e.g. gene therapy, RNA, gene editing), effective communication, business and strategic acumen. Primary...
-
Senior Director CMC Technical Innovation
2 weeks ago
Cambridge, United States Proclinical Staffing Full timeSenior Director CMC Technical Innovation - Gene Therapies - Permanent - Massachusetts Proclinical is seeking a Senior Director of CMC Technical Innovation to focus on Gene Therapy. This role requires a combination of CMC technical expertise (e.g. gene therapy, RNA, gene editing), effective communication, business and strategic acumen. Primary...
Associate Director, Global Regulatory Science, CMC
3 months ago
The Role:
The Associate Director, Global Regulatory Science - CMC will be responsible for leading regulatory CMC strategy and execution for one or more programs. The Associate Director will be responsible for developing global regulatory CMC strategies and collaborating with key stakeholders to execute the strategies in alignment with regulatory requirements and business priorities. The individual will be expected to provide guidance to CMC teams and collaborate within the Global Regulatory Science CMC team. The Associate Director will be responsible for preparation of CMC and Quality related Health Authority correspondence and regulatory submissions. The candidate will need to successfully manage multiple projects in a fast and results-oriented environment to deliver on maintaining a new, transformative medicine for patients. The Associate Director can be based at Norwood or Cambridge, MA or Basel, Switzerland sites.
Here's What You'll Do:
* Develop and implement effective regulatory CMC strategies for global IND/CTA/BLA/MAA
* Identify regulatory risks and mitigation strategies
* Provide regulatory CMC advice to manufacturing and quality teams
* Review documents for submission-readiness, to ensure that all submissions conform to global Health Authority regulatory requirements
* Lead regulatory CMC discussions and interactions with Health Authorities to facilitate review and approval of submissions
* Assess change controls related to quality/manufacturing changes
* Support development of regulatory processes and procedures
* Support the creation and maintenance of CMC submission tools and templates
* Provides interpretation of regulatory guidance documents, regulations and directives
* Advises Manufacturing, Quality and Process/Analytical Development groups regarding their applicability and impact on internal programs
Here's What You'll Bring to the Table:
* BS/MS/PhD in Molecular Biology, Pharmaceutics, Chemistry, Chemical Engineering, or closely related field is required
* 8+ years of experience in the pharmaceutical/biotech industry, manufacturing and/or analytical focus
* 5+ years of experience in Biologics focused Regulatory CMC
* Strong knowledge of current US CMC regulations, including CTD format and content of CMC regulatory submissions
* Knowledge of current CMC regulations outside of the US, as well, is preferred
* Knowledge of and broad experience with regulatory procedures and legislation related to CMC aspects of drug development, product registration, and post-approval lifecycle management (LCM)
* Ability to effectively collaborate in a dynamic, cross-functional matrix environment to meet critical regulatory milestones
* Ability to work independently
* Exceptional written and oral communication
Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:
* Highly competitive and inclusive medical, dental and vision coverage options* Flexible Spending Accounts for medical expenses and dependent care expenses* Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities* Family care benefits, including subsidized back-up care options and on-demand tutoring* Free premium access to fitness, nutrition, and mindfulness classes* Exclusive preferred pricing on Peloton fitness equipment* Adoption and family-planning benefits* Dedicated care coordination support for our LGBTQ+ community* Generous paid time off, including:* Vacation, sick time and holidays* Volunteer time to participate within your community* Discretionary year-end shutdown* Paid sabbatical after 5 years; every 3 years thereafter* Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents* 401k match and Financial Planning tools* Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options* Complimentary concierge service including home services research, travel booking, and entertainment requests* Free parking or subsidized commuter passes* Location-specific perks and extras
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Moderna is a smoke-free, alcohol-free and drug-free work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply
Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We're focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)
*
#J-18808-Ljbffr
