RegCMC Small Molecules Team Lead

2 weeks ago

Cambridge, United States Biogen Full time
Job DescriptionJob DescriptionJob Description

About this role

The role can be US based hybrid in Cambridge or RTP or Baar based in Switzerland

As Regulatory CMC Small Molecules Team Lead you are responsible for the line management of direct reports, with responsibilities for the  small molecule portfolio. The Regulatory CMC Team Lead with the Regulatory CMC Global Regulatory Lead (RegCMC GRL), where applicable, assigns activities to the team members, supports the team members in setting regulatory CMC strategies and their daily work. Where a program does not have a designated RegCMC GRL you provide regulatory strategic support and advice for the program when required.  You ensure coaching is provided as needed and the talents of the team members are enhanced through the assigned projects and through development opportunities.  In this role you are responsible for defining regulatory CMC strategy, planning and the preparation of global CMC regulatory submissions to achieve timely approvals of clinical trial applications, initial marketing authorization applications and lifecycle changes with a focus on small molecule programs, identifying and assessing global regulatory risks, implementing filing readiness strategy, leading global CMC Health Authority interactions, and providing regulatory CMC leadership on the cross functional sub teams for the assigned program. 

 

What you'll do

 

  • Accountable for line management and development of direct reports.
  • Managing RegCMC small molecule resources efficiently – budget tracking, ensure proper resources allocation (including external regulatory partnerships), enhance knowledge sharing and support the team to prioritize activities.
  • As part of RegCMC, lead the development of working processes and activities to increase the efficiency within RegCMC function including continuous improvement initiatives and development of agreed RegCMC strategic frameworks.
  • Accountable for strategy, planning, definition of content, preparation, review and approval of RegCMC submissions and responses to Health Authority questions.
  • Highlight and proactively communicate anticipated and ongoing critical RegCMC issues throughout the product lifecycle, in a timely manner, to key stakeholders as appropriate.
  • Monitor and influence changes in the global RegCMC environment in alignment with business needs.

 

 

What we offer

A leadership role where you are able to work with accountability, both independently and within project teams or committees to attain group goals and key project milestones. Inclusive leadership, strategic thinking, change champion leadership, and risk assessment, including ability to integrate overall business objectives into the goals/vision/values of department and to communicate these effectively.

 

Qualifications

  • BS University degree in Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science; Graduate degree preferred.

Regulatory Skills

  • At least 10 years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 8+ years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field.
  • Successful leadership in delivering CMC sections of marketing authorizations, clinical trial applications (CTA/IND) and post-approval submissions for new oligonucleotide, and/or complex chemical entities
  • Broad background of registration experience gained from working in the pharmaceutical industry or a regulatory authority in one or more of the ICH regions.
  • Extensive experience of direct communication and negotiation with regulatory agencies on CMC topics
  • Knowledge of global guidance, regulations and ICH/GMP requirements
  • Demonstrated competence in leading cross-functional teams and operating within a matrix organizational structure

Leadership/Management Skills

  • Demonstrated competency in planning, project management and tracking projects of high complexity and risk with clearly defined critical paths.
  • Demonstrated ability to pioneer and execute on an agreed global regulatory CMC strategy and ensure that results are in alignment with business priorities.
  • Proven ability to manage projects across global locations/time zones.
  • Proven ability to create strong, productive working relationships in a global setting with many different cultures.
  • Enthusiastic orientation to teamwork. Works inclusively and collaboratively, effectively and efficiently with others internally and externally. Strong conflict resolution skills: proven abilities to effectively and expeditiously reach satisfactory resolution among all involved parties.
  • Competence in people development and management.


Additional Information

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts

  • Scientist II, Small Molecule Chemistry Development

    Found in: Resume Library US A2 - 6 days ago

    Cambridge, Massachusetts, United States Biogen Full time

    Job Description About This Role   Biogen is seeking a motivated and creative process chemist to join our small molecule development team in Cambridge, MA. This individual will provide support for chemical process research and development of Biogen’s small molecule programs from pre-clinical, clinical stage of development to commercial products. This...

  • Sr. Scientist, Small Molecule Formulation Development

    Found in: Resume Library US A2 - 7 days ago

    Cambridge, Massachusetts, United States Biogen Full time

    Job Description Biogen is seeking a qualified candidate to fill a Scientist II or Senior Scientist position within its Small Molecule Development organization. This individual will work with other scientists to develop drug product formulations including pediatric formulations to support small molecule formulation development from pre-clinical through...

  • Head of Product Development and RegCMC, Biologics and Advanced Therapy Medicinal Products

    Found in: Resume Library US A2 - 1 week ago

    Cambridge, Massachusetts, United States Biogen Full time

    Job Description This role is located in Cambridge, MA or RTP, NC. The Head of Product Development and RegCMC, Biologics and Advanced Therapy Medicinal Products leadership role in PO&T is responsible for the process, analytical, and technology development of all biologic and advanced therapy medicinal product (ATMP) modalities including existing...

  • Director, Bioanalytical DMPK

    Found in: beBee S US - 2 weeks ago

    Cambridge, United States Mersana Therapeutics, Inc Full time

    Mersana is growing and has an exciting new opportunity for a Director, Bioanalytical DMPK to join our team.As the Director, Bioanalytical DMPK, you will have the opportunity to lead a team of ligand binding assay (LBA) and mass spectrometry laboratory scientists in developing bioanalytical assays for new and existing ADC programs for preclinical...

  • Associate Director/Director, CMC Program Leadership

    6 days ago

    Cambridge, United States MOMA Therapeutics Full time

    MOMA Therapeutics is looking for an experienced Associate Director/Director, CMC Program LeadershipImagine joining a company where you.... Will be part of an experienced and resilient team that is collectively unstoppable, trusts one another, and selflessly collaborates Will work with incredible humans who are committed to the discovery of transformative...

  • Director, Bioanalytical DMPK

    Found in: beBee jobs US - 2 weeks ago

    Cambridge, Massachusetts, United States Mersana Therapeutics, Inc Full time

    Mersana is growing and has an exciting new opportunity for a Director, Bioanalytical DMPK to join our team.As the Director, Bioanalytical DMPK, you will have the opportunity to lead a team of ligand binding assay (LBA) and mass spectrometry laboratory scientists in developing bioanalytical assays for new and existing ADC programs for preclinical...

  • HPLC Small Molecule Scientist

    Found in: Resume Library US A2 - 6 days ago

    Cambridge, Massachusetts, United States Eurofins USA PSS Insourcing Solutions Full time

    Job Description Execute testing of assigned analysis type for routine sample submissions for chemical and physical properties characterization of drug substance and drug product Performing dissolution testing to inform formulation development are essential Identify and help to resolve equipment and basic test method issues Provide feedback to client on...

  • Head of Biochemistry and Biophysics

    6 days ago

    Cambridge, United States MOMA Therapeutics Full time

    Job DescriptionJob DescriptionMOMA Therapeutics is looking for an experienced Head of Biochemistry and Biophysics Imagine joining a company where you….Will be part of an experienced and resilient team that is collectively unstoppable, trusts one another, and selflessly collaboratesWill work with incredible humans who are committed to the discovery of...

  • Head of Biochemistry and Biophysics

    2 weeks ago

    Cambridge, United States MOMA Therapeutics Full time

    Job DescriptionJob DescriptionMOMA Therapeutics is looking for an experienced Head of Biochemistry and Biophysics Imagine joining a company where you….Will be part of an experienced and resilient team that is collectively unstoppable, trusts one another, and selflessly collaboratesWill work with incredible humans who are committed to the discovery of...

  • Principal Scientist

    Found in: beBee S US - 2 weeks ago

    Cambridge, United States Nuvalent Inc Full time

    We are seeking an entrepreneurial Medicinal Chemist with strong technical and problem-solving skills in organic and medicinal chemistry.The scientist in this position will work with the Nuvalent team, including the scientific founder, and will be responsible for leading medicinal chemistry efforts on at least one early-stage project operating under a...

  • Principal Scientist

    Found in: beBee jobs US - 2 weeks ago

    Cambridge, Massachusetts, United States Nuvalent Inc Full time

    We are seeking an entrepreneurial Medicinal Chemist with strong technical and problem-solving skills in organic and medicinal chemistry.The scientist in this position will work with the Nuvalent team, including the scientific founder, and will be responsible for leading medicinal chemistry efforts on at least one early-stage project operating under a...

  • Associate Director

    Found in: beBee S US - 2 weeks ago

    Cambridge, United States Cullinan Oncology, Inc Full time

    Anchored in a deep understanding of immuno-oncology and translational cancer medicine, we leverage our scientific excellence in small molecules and biologics to create differentiated ideas, identify unique targets, and select the optimal modality to develop transformative therapeutics across cancer indications.A successful incumbent would help integrate...

  • Senior Scientist, Medicinal Chemistry

    Found in: beBee S US - 2 weeks ago

    Cambridge, United States Relay Therapeutics Full time

    We are looking for a self-motivated, creative, and experienced medicinal chemist to join our team and help drive projects from lead generation through candidate selection in a fast-paced, highly collaborative environment.Be an integral part of a multi-disciplinary lead optimization team (alongside pharmacologists, computational chemists, biophysicists, and...

  • Lead Business Analyst, Enterprise Applications

    7 days ago

    Cambridge, United States Relay Therapeutics Full time

    The Opportunity We are seeking a dynamic, thoughtful Enterprise Applications Engineer/Analyst. Reporting to the Head of IT Operations, this individual will lead our technology engagements with our Finance, Accounting, People, Legal, Corporate Communications, Investor Relations, Facilities and Operations teams. They will align technology capabilities to...

  • Senior Scientist, Medicinal Chemistry

    Found in: beBee jobs US - 2 weeks ago

    Cambridge, Massachusetts, United States Relay Therapeutics Full time

    We are looking for a self-motivated, creative, and experienced medicinal chemist to join our team and help drive projects from lead generation through candidate selection in a fast-paced, highly collaborative environment.Be an integral part of a multi-disciplinary lead optimization team (alongside pharmacologists, computational chemists, biophysicists, and...

  • Technical Associate I, Shoulders Lab

    Found in: Talent US C2 - 6 days ago

    Cambridge, United States MIT Full time

    Job Description TECHNICAL ASSOCIATE I , Chemistry-, to join a group that is interested in understanding how cells fold proteins and using the tools of evolution to understand proteostasis and develop next-generation biomolecules. Will work in the area of protein homeostasis and assist with projects studying the folding and quality control mechanisms...

  • Engineering Team Lead

    7 days ago

    Cambridge, United States Massachusetts Institute of Technology Full time

    ENGINEERING TEAM LEAD MIT Quest for Intelligence - Systems Engineering Team To lead and supervise a team that is building and maintaining artificial intelligence and machine learning (ML) computational platforms designed to advance Quest missions research, compose and benchmark models of natural intelligence, and assess the utility of systems in solving real...

  • Benefits, HR Operations

    7 days ago

    Cambridge, United States Fulcrum Therapeutics Full time

    **Company Overview** Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum's two lead programs in clinical development are losmapimod, a small molecule for the treatment of facioscapulohumeral muscular dystrophy (FSHD)...

  • Director, Quality Management Systems

    Found in: Talent US C2 - 2 weeks ago

    Cambridge, United States Apex Systems Full time

    Job#: 2019758 Job Description: Director, Quality Management Systems 2019758 Location: Boston,MA(Hybrid / Onsite) Therapeutic Area: Small molecule Pharma Job Overview: The role requires leading the development, design, and maintenance of the Quality Management System to ensure efficiency, effectiveness, and compliance with quality regulations...

  • Director / Senior Director, Process Chemistry

    Found in: Appcast Linkedin GBL C2 - 2 days ago

    Cambridge, United States Alkeus Pharmaceuticals, Inc. Full time

    About Alkeus Pharmaceuticals:Alkeus Pharmaceuticals, Inc. is a late-stage biopharmaceutical company developing transformative therapeutics to address serious, progressive eye diseases that lead to blindness. Our lead compound, gildeuretinol (ALK-001), is an oral investigational drug being developed for the treatment of Stargardt disease (STGD) and Geographic...