Average salary: $173,837 /yearly
More stats ...of my knowledge.
Job Description
Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the following requirements: Masters degree in Regulatory Affairs or related field plus 2 years of related experience...
Suggested
Minimum wage
Holiday work
Full time
Temporary work
Local area
Remote job
...possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program leadership and develop CMC regulatory strategy for global vaccine programs in various stages of development...
Suggested
Minimum wage
Holiday work
Full time
Temporary work
Local area
Remote job
Worldwide
...the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Join Takeda as a Director, GRA CMC Pharmaceuticals, Oligonucleotides where you will lead the GRA CMC Pharmaceuticals regulatory team in the development and...
Suggested
Minimum wage
Holiday work
Full time
Temporary work
Local area
Remote job
Worldwide
...Summary of Position: The Director Regulatory CMC will be responsible for developing and delivering innovative regulatory CMC strategies for product development and approval. With limited guidance from the EVP Regulatory Affairs & Quality Assurance , the incumbent acts...
Suggested
Local area
Remote job
...Consultant Regulatory CMC - Permanent - Boston, MA
Proclinical is seeking a Senior Regulatory Affairs Associate or a Regulatory Affairs Consultant with a strong background in CMC post-approval. This permanent position is located in Boston, MA.
Primary Responsibilities...
Suggested
Permanent employment
...Job Description
Job Description Join Frontier Medicines on an exciting journey as our newest Senior Manager/Associate Director in CMC Development, located at either our Boston or South San Francisco office.
As a crucial member of our team, reporting directly to...
Suggested
Holiday work
Temporary work
...colleagues in quality and commercial organizations to manage pipeline products and bring current products to industry standards.
Represent CMC and GRA on key governance committees and play a critical role in driving the organization towards innovative approaches for the...
Suggested
Minimum wage
Holiday work
Full time
Temporary work
Local area
Worldwide
...a key leadership role for the development of the In Vivo franchise at CRISPR. Reporting to the Senior Director of Regulatory Affairs CMC, you will work closely with cross-functional teams and partners to bring multiple novel therapies to patients. As the Regulatory CMC...
Suggested
Contract work
Remote job
...We are actively searching for an innovative and motivated Business Development Manager / Director, DP&C (Discovery, Preclinical & CMC). This role involves managing and cultivating business relationships, representing Pharmaron as the preferred CRO for prospective clients...
Suggested
Contract work
Temporary work
Flexible hours
.... You need to be the kind of person who gives everything you've got. Our patients deserve the best. Our nurses give it to them.
CMC is a 16-bed intermediate care unit. The unit specializes in the care of advanced heart failure, cardiac transplant (pre and post) and...
Suggested
Work experience placement
Local area
...•Experience with ELISA-based specificity screening of mAbs (PSR, DNA, insulin, serum binding assays) is desirable.
•Experience in CMC management of analytical method development/validation and DS/DP specification under ICH guideline
•Experience with Flow cytometry...
Suggested
Worldwide
...expertise and commit resources to execute specific project tasks.
Review, interpret and communicate data cross-functionally within CMC and project teams.
Plan and implement resolutions to technical problems/issues.
Represent functional area on GCT project teams...
Suggested
Minimum wage
Holiday work
Full time
Contract work
Temporary work
Local area
Worldwide
...with internal groups such as Analytical Development, Formulation Development, Supply Chain, Global Quality Assurance, and Regulatory CMC to advance Cerevel's pre-clinical and clinical candidates
Required Qualifications
Significant experience in small molecule process...
Suggested
Work experience placement
...Oncology's accounting policies and procedures positions on a range of accounting topics, implementing SOX, providing support to clinical, CMC, medical and research teams from the Finance side, and managing a team of accounting professionals. This role leads all accounting...
Suggested
Holiday work
Full time
Remote job
Flexible hours
...worldwide.
Join Takeda as a Senior Director, GRA Pharmaceuticals- Small Molecule where you will establish collaboration with Global CMC teams and leadership through networks and enable CMC regulatory teams success in meeting goals/objectives. You will also influence...
Suggested
Minimum wage
Holiday work
Full time
Temporary work
Local area
Remote job
Worldwide
...the function including (including regulatory, technical, and financial strategies) and is responsible for the management of all CMC analytical testing a ctivities for the global R&D portfolio including the e stablish ment of GMP labs for release testing...
Minimum wage
Holiday work
Full time
Temporary work
Local area
Remote job
Night shift
...will work in a project team environment, interfacing internally with multiple functional areas such as Biology, Chemistry, DMPK/Tox, CMC and Clinical Development. The Project Manager will also interact externally with alliance partners, vendors, and others.
Responsibilities...
Overseas
...Roles & Responsibilities:
Collaborate with mRNA CoE functional heads, Global Project Managers, CMC Leaders, CMC Project managers to proactively plan, monitor and update project operational plans and assign resource loading in Company's Planisware system "RDPM...
For contractors
...GPT implements its plans and adheres to key development milestones for assigned projects.
* Accountable for aspects of pre-clinical, CMC, clinical plans and programs across from Post-PoC through commercial approval for assigned projects.
* Leads the global project...
Temporary work
Local area
Worldwide
Work alone
Flexible hours
3 days per week
...regulatory document workflows, organize information into regulatory information management systems.
Partner with the Clinical team and the CMC team as well as external Regulatory and QA consultants to ensure regulatory plans are well established and maintained and leads to...
Summer work
Local area
Work alone
Flexible hours
...Job Responsibilities
Provide organizational support for CMC and LCM initiatives in Analytical Sciences & Technology
Generate and maintain AS&T book of work for ongoing projects and regulatory submissions
Compile and track Quality Management System (QMS...
Contract work
Temporary work
...management system
Prior authoring of eCTD Module 3 sections supporting regulatory submissions
Relevant industry experience in CMC-related scientific writing, QC activities and processes in a regulated (GMP-compliant) environment including batch production records...
Remote job
...required to actively support the preparation of regulatory filings. Technical collaboration and integrated planning with PepGen’s internal CMC team and associated CMO/CRO organizations are key success factors, along with experienced leadership for the completion of planned...
...as the subject matter expert on protein stability and formulation. Represent the formulation development function on cross-functional CMC project teams.
Author relevant sections in regulatory submissions (IND, DMF, BLA, etc.) and technology transfer documentation....
Full time
Local area
Remote job
...of our drug products. This individual will join a multidisciplinary team of scientists and engineers and contribute to a variety of CMC activities in a fast-paced, agile and highly collaborative environment.
KEY RESPONSIBILITIES
Routinely perform batch and...
Local area
Remote job
...team that aims to advance preclinical gene editing candidates into the clinic and work closely with discovery, process development, CMC, and internal quality control groups.
Job Responsibilities
Develop, optimize and execute biophysical methods intended for a variety...
...Regulatory guidelines by providing oversight and management of the global contract testing laboratories in partnership with the Company's CMC Team. The Associate Director also participates in drafting and reviewing CMC sections of the IND, IMPD and BLA/NDA submissions. This...
Holiday work
Contract work
Flexible hours
...schedule and that there are smooth transitions from process development to successful regulatory submissions.
Write and evaluate CMC sections & technical reports needed for regulatory submissions.
QUALIFICATIONS:
Master's or PhD in Chemical Engineering, Microbiology...
...support for in-house drug discovery and development activities. The successful candidate also will work very closely with experienced CMC and discovery teams to develop and qualify phase-appropriate analytical methods for various chemical entities like peptides, oligos...
...clinical supply documentation in support of labeling and packaging activities as well as supply chain documentation to support critical CMC activities.
* Support the collection of clinical supply chain metrics and/or participate in critical non-pipeline activities as a...
Holiday work
Remote job
Relocation
Visa sponsorship
Flexible hours
Shift work
3 days per week