Nationwide, Senior Regulatory CMC Strategist – Complex Biologics/Combined Products ; Full-time and part-time permanent roles are available
Location: Remote: 100% home-based with ~25% travel
Are you a senior-level Regulatory CMC Strategist and Writer with 6 to 10+ years of experience guiding biotechnology products through the full development lifecycle? We are looking for amazing candidates with the end-to-end knowledge and line-of-sight needed to ensure successful outcomes with regulators and facilitate a smooth path to licensure. We want someone who can lead or support, as needed, Regulatory CMC interactions with global health agencies, whether through submission packages, virtual or face-to-face meetings, responses to questions, or pre-approval inspections.
We believe success is based on building a foundation of trust with both clients and regulators, which is achieved through:
thoughtful assessments and communication of risks;
formulating risk mitigation strategies;
collaborating effectively and influencing decision-makers for the best technical packages, positioning, and messaging; and
honoring commitments to ensure high-quality, on-time deliverables.
The candidate will regularly develop and review key technical documentation such as marketing applications, protocols, reports, development plans, investigations, change controls, post-approval supporting documentation, SOPs, and policies. Candidates with expertise in process validation is a plus. We are specifically looking for professionals with the following product experience:
Cell and gene therapies
Live and attenuated virus vaccines
Therapeutic proteins, fusion proteins, recombinant proteins, immunoglobulins, antibody-drug conjugates
Novel excipients and adjuvants
Mammalian, bacterial, yeast, and insect host cell lines
Virus seed banks
Solutions for injection and IV administration
Biologic/device combination products (Autoinjectors, prefilled syringes, dual-chamber cartridges; Electroporation)
Lyophilized products for reconstitution
What We’re Looking For:
The Senior-level Regulatory CMC Strategist will help us provide regulatory strategy and technical writing services to biotech, biosimilar, and combination therapy companies engaged in research, development, manufacturing, and clinical trials. Projects span a full range of product types, including biologics, vaccines, gene therapies, tissue and cell therapies, biosimilars, and combination drug-device products.
As a senior member of this team you will work collaboratively with other GLOBAL team members and with client companies to support the development of international CMC regulatory strategies and content plans for the lifecycle of products. Successful candidates must have extensive experience in the Regulatory CMC space and possess working knowledge of industry-standard biologics manufacturing and/or analytical techniques. The candidate must be comfortable distilling technical information from multiple sources into concise and well-crafted written deliverables that are aligned with GLOBAL’s highest standards of quality and meet both client and health authority expectations. Crazy-good ninja-like attention to detail and communication skills are absolute musts.
As a virtual company, GLOBAL employees work remotely out of their own home offices and must have stable and reliable internet and phone service, and an environment conducive to the type of work and to having professional interactions with team members and clients. Critical to success is being self-motivated and responsible to manage your workload and deliver projects on time without direct supervision. You also need to be friendly, client-focused, and outgoing in asking questions to educate yourself on the technical elements of the project.
What You Will Be Doing:
Play a key role in supporting the development of global CMC regulatory strategies and content plans for combination products throughout the lifecycle of the product
Implement regulatory strategies and prepare the submission of CMC sections, marketing applications, supplements, and variations
Understand the client well enough to ensure the CMC regulatory strategy is in alignment with the global regulatory strategy, Therapeutic Area portfolio, regional strategies, commercial strategy, and the Target Product Profile (TPP)
Interface with Manufacturing, Supply Chain, Quality, CMOs, and other strategic partners
Identify risks and diplomatically propose plans to mitigate risks
Oversee global and US CMC regulatory support and submissions for various stages of development and commercial products
Plan, author, and review CMC components of briefing packages in connection with health authority scientific advice and (pre-)submission meetings
Provide technical review and approval of test protocols, reports, and other source documents
Assist in negotiations with regulatory agencies to resolve CMC issues and shepherd proactive interactions with regulators
Support client teams wherever needed and provide direction on the interpretation and application of global CMC regulations and guidance related to biologics and/or combination products
Ensure communication and alignment of the CMC regulatory strategy through partnership and communication with therapeutic area regulatory affairs leaders, project development teams, and all other internal and external stakeholders
Maintain a high-level understanding of US and global (ICH, FDA, EMA) regulatory requirements
Build positive relationships with clients and co-workers
Participate in GLOBAL business development opportunities; attend, represent GLOBAL and occasionally speak at industry conferences
Mentor junior GLOBAL CMC team members and participate in developing internal training programs
What Qualifications and Skills are Required or Preferred:
The ideal candidate will have the following qualifications and experience:
REQUIRED: A Bachelor’s degree with 10+ years of regulatory CMC-specific complex biologics, biosimilar, or combination product industry experience OR a Master’s degree with 8+ years of industry experience OR a PhD with 6+ years of industry experience is required (a degree in pharmacy, chemistry, biology, or a related science/technical field is preferred)
REQUIRED: At least 6+ years of experience in CMC-specific regulatory strategy role, including planning and ownership of submissions such as marketing applications and briefing documents AND developing CMC regulatory strategy for pre- and post-approval of complex biologics or combination products
REQUIRED: Direct experience in the preparation (authoring, editing and review) of regulatory submissions (Module 3) in most of the following submissions IND/IDE/CTA/NDA/BLA/MAA
REQUIRED: Significant knowledge of biologics, biosimilars, and/or combination therapy and device regulations
Previous experience with medical device submissions PMAs, 510(k)s, IDEs, MAFs, CE Mark Technical Files for those with combination therapy experience is preferred
Experience in leading Health Authority meetings (FDA, EMA and national agencies) is preferred
Previous experience managing directly/indirectly other people in a matrix team environment is required, with remote experience preferred
Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving
GLOBAL is an EEO/AA employer committed to providing opportunities to minorities, women, veterans, and individuals with disabilities. The position is home-based in the U.S., but it requires up to 25% travel as needed. We are offering a competitive base salary plus generous benefits, as well as significant bonuses and long-term profit-sharing opportunities (aka, “skin in the game”) upon successful realization of new growth.