Consultant Regulatoty CMC

2 weeks ago

Boston, United States ProClinical Full time

Consultant Regulatory CMC- Permanent

Experience, qualification, and soft skills, have you got everything required to succeed in this opportunity Find out below.
- Boston, MAProclinical 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:The successful candidate will provide lifecycle management support to a broad, global portfolio of commercial products.Skills & Requirements:Minimum of 3 years of significant post-approval CMC experience in global markets, including experience with the FDA and EU Agencies.Excellent communication skills and the ability to multi-task, stay organized, and prioritize.Incredible attention to detail and previous experience leading meetings and planning submission timelines.Fluency in French is a plus, but not required.CMC Vaccines authoring experience is preferred, but consideration will be given to those with strong CMC Biologics authoring experience.The Consultant Regulatory CMC will:Conduct CMC Variations/Submissions and CMC Change control assessments.Carry out global assessment of change controls in current markets and support for new Markets Assessment of existing change controls in support of market extension.Lead initial planning and determination of content and timing for submission planning.Interact with other groups for confirmation of timelines considering all relevant parameters for accurate planning.Maintain a record of activities to ensure all product activities are kept on target.Coordinate submission writing, review, and approval process with contributors and stakeholders.Dispatch CMC dossiers and secure document approvals.Respond to Health Authority Questions and support technical aspects of queries in coordination with the impacted SMEs.Update HA question record in Vault and coordinate dispatch of information to Affiliate noting status changes in Veeva.If you are having difficulty in applying or if you have any questions, please contact Funmi Gbadamosi at +(1) (XXX) XXX-XXXX or f.gbadamosi@proclinical.com.Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.Proclinical Staffing is an equal opportunity employer.

  • Consultant Regulatoty CMC

    2 weeks ago

    Boston, MA, United States ProClinical Full time

    Consultant Regulatory CMC- Permanent - Boston, MAProclinical 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:The successful candidate will provide lifecycle management support to a broad, global...

  • Sr. Manager Regulatory

    1 week ago

    Boston, United States Scientific Search Full time

    Sr. Manager Regulatory Affairs - CMC Location: Remote Industry: Biopharma Contract: 1 year contract Our California based biopharmaceutical client working in the rare disease space with one approved product and others behind it has tasked our team in finding them a Regulatory Affairs Consultant for a 1 year contract assignment. Working with the product leads,...

  • Head of Regulatory Affairs

    1 week ago

    Boston, United States Discera Search Full time

    Lead the regulatory efforts for IND-enabling activities, including the preparation of the Investigational New Drug (IND) application for our groundbreaking oncology and CNS therapies targeted for submission this year and early next. Be the go for all things regulatory and acting as a key voice to the future of all trials, SOPs and strategy for these early...

  • Director, Regulatory Affairs

    6 days ago

    Boston, United States Imbria Pharmaceuticals Full time

    Company OverviewImbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...

  • Director, Regulatory Affairs

    1 week ago

    Boston, United States Imbria Pharmaceuticals Full time

    Company OverviewImbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor to...

  • Head of Patient Access To Innovation

    6 days ago

    Boston, United States VCLS Full time

    Head of Patient Access to Technology & Innovation (PATI) (VP) VCLS are seeking to appoint a Head of Patient Access to Technology & Innovation (VP). The role will see you responsible for our flagship and primary revenue generating business division and igniting a transformation that will see VCLS expanding our service offering, deepening our client...

  • VP of Regulatory Affairs

    1 week ago

    Boston, United States Compass Therapeutics Full time

    Job DescriptionJob DescriptionCompass Therapeutics, Inc. is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. Compass' scientific focus is on the relationship between angiogenesis, the immune system and tumor growth. Our pipeline of novel product candidates is...

  • VP of Regulatory Affairs

    3 weeks ago

    Boston, United States Compass Therapeutics Full time

    Job DescriptionJob DescriptionCompass Therapeutics, Inc. is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. Compass' scientific focus is on the relationship between angiogenesis, the immune system and tumor growth. Our pipeline of novel product candidates is...

  • Head of Patient Access To Innovation

    3 weeks ago

    Boston, Massachusetts, United States VCLS Full time

    Head of Patient Access to Technology & Innovation (PATI) (VP)   VCLS are seeking to appoint a Head of Patient Access to Technology & Innovation (VP). The role will see you responsible for our flagship and primary revenue generating business division and igniting a transformation that will see VCLS expanding our service offering, deepening our client...

  • Senior Director, Nonclinical Safety

    1 week ago

    Boston, United States Nimbus Therapeutics Full time

    Nimbus has an outstanding opportunity for an exceptional Senior Director of Nonclinical Safety (Toxicology) to join our rapidly growing team. This role will lead the safety strategy, from discovery through both nonclinical and clinical stages, and direct all phases of early investigative toxicology and in vivo non-GLP and GLP toxicology studies, in...

  • Associate Director/Director, Global Program Management

    3 weeks ago

    Boston, Massachusetts, United States Scorpion Therapeutics Full time

    Scorpion is a pioneering clinical-stage oncology company redefining the frontier of precision medicine to deliver optimized and transformational therapies for larger populations of patients with cancer. Scorpion has built a proprietary and fully integrated platform of the most advanced technologies across cancer biology, medicinal chemistry, and data...

  • SENIOR DIRECTOR, NONCLINICAL SAFETY

    1 week ago

    Boston, MA 02298, USA, United States Nimbus Therapeutics Full time

    Nimbus has an outstanding opportunity for an exceptional Senior Director of Nonclinical Safety (Toxicology) to join our rapidly growing team. This role will lead the safety strategy, from discovery through both nonclinical and clinical stages, and direct all phases of early investigative toxicology and in vivo non-GLP and GLP toxicology studies, in...