Regulatory CMC– Biosimilar/Biologics

Description

We are looking for amazing candidates with at least 10 years of Regulatory CMC strategy experience who can lead or support biologics projects for successful outcomes with regulators. Ideal candidates will have acquired the end-to-end knowledge and line-of-sight needed to facilitate a smooth path to licensure and understand the needs of the post-approval space, as well as having lead health authority interactions (ie, submission packages, virtual or face-to-face meetings, responses to questions, pre-approval inspections, etc).

Experience must be Regulatory CMC for Biosimilar therapeutic proteins, or with combination product experience a plus for Regulated Markets like USA, Europe, Canada.

The candidate will regularly lead project teams and will be responsible to author and review key submission and technical documentation such as agency meeting packages, INDs/CTAs, marketing applications, post-approval submissions, risk assessments, change controls, development plans, protocols, reports, investigations, SOPs, and policies.

What We’re Looking For:

The 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 live and attenuated vaccines, gene therapies, tissue and cell therapies, protein therapies, biosimilars, and combination products.

You will work collaboratively with other BSS 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 BSS’s highest standards of quality and meet both client and health authority expectations.

In-depth attention to detail and communication skills are absolute musts.

What You Will Be Doing:

- Play a key role in supporting the development of BSS CMC regulatory strategies and content plans for biologic and combination products for regulated market
- Work with our partners to formulate and implement successful CMC and regulatory strategies for assigned products
- Lead, plan, author, and review CMC submission documents, including agency meeting packages; m3 and m2.3 for clinical and marketing applications, supplements, and variations; responses to agency information requests
- Ensure CMC regulatory strategy is aligned with the BSS regulatory strategy, Therapeutic Area portfolio, regional strategies, commercial plans, and the Target Product Profile (TPP)
- Interface with Manufacturing, Supply Chain, Quality, CROs, and other strategic partners
- Identify risks and diplomatically propose plans to mitigate risks
- 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, eg, Interacts, Type meetings, Scientific Advice meetings
- Support BSS teams wherever needed and provide direction on the interpretation and application of BSS CMC regulations and guidance related to biosimilars,



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 regulatory requirements
- Build positive relationships with clients and co-workers

Requirements

What Qualifications and Skills are Required or Preferred:

- Education and industry experience: 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 (a degree in biology, chemistry, or a related science/technical field)
- Specific and hands-on work experience: At least 5 years in CMC-specific regulatory strategy role that included leading or being a strong contributor to agency interactions and the development of written agency communications and submission packages AND in the development of CMC regulatory strategy for pre- and post-approval of complex biologics/biosimilars and/or combination products
- REQUIRED: Direct experience in the authoring, editing, and review of Module 3 for INDs/CTAs and/or BLAs/MAAs
- REQUIRED: Significant knowledge of biologics, biosimilars, and/or combination therapy regulations
- REQUIRED: Demonstrated sound understanding of relevant technical areas (ie, biologics manufacturing and analytics) and the ability to be creative and imaginative in the approach to new and diverse problem solving
- REQUIRED: Experience and comfort working remotely and in virtual environments
- PREFERRED: Has lead health authority interactions (FDA, EMA, and other national agencies)
- PREFERRED: Has managed directly/indirectly other people in a matrix team workplace

📌 Director / Senior Director - Regulatory Science (Mumbai)
🏢 BioSimilar Sciences India
📍 Mumbai