Company Description:

With over 78 years of experience, Bioplus Life Sciences is a pharmaceutical company based in Bengaluru. We focus on advanced Biotechnology and have programs in late-stage clinical phases for global unmet needs. Our pipeline includes pre-clinical programs and blockbuster Novel therapeutics,
with a strong emphasis on R&D and Clinical Development.

We are delighted to invite you to explore an opportunity of learning, contributing and discovering science and medicine with us as part of our global research team. Bioplus Life Sciences and its affiliate Theialife
Inc, USA & Akeso Biopharma, Singapore have a novel portfolio of first in class and best in class novel therapeutics in discovery stage to Phase 3 clinical stage.

Theialife is currently building a global leadership team in Boston, as a prerequisite to list on NASDAQ.

Our lead molecule ND 10 for early onset paediatric myopia
control will be applying for EU Marketing Authorization in Q1-2025 and US FDA
pre submission meeting NDA meeting also in Q1-2025.

As you are probably familiar with the drug discovery journey you will appreciate that is the culmination of 18 years of effort, perseverance, and devotion to a single-minded goal of creating a global
biopharmaceutical company. The myopia drug opportunity is itself over USD 20 billion and there is no other therapeutic in clinical development except Atropine which has had efficacy endpoint issues. We are adding new large manufacturing capability including a 2-million-liter microbial fermentation bio
foundry and significant dosage form capacity.

By 2030 we intend to be amongst the World’s top 5 Ophthalmology innovation led global companies.

To support, build and develop our pipeline we are looking to add Scientists, Doctors and Engineers and Technical People to our team of likeminded dedicated science warriors who have devoted their lives to pursue excellence and contribute to finding medical solutions for significant global unmet medical needs.

POSITION SUMMARY:

Bioplus Life Sciences seeks a Director – Regulatory Affairs to lead global regulatory strategy and submissions for its pipeline of novel biopharmaceuticals, including 4 advanced-stage programs (Phase 2/3) in ophthalmology and metabolic disorders. This role requires a strategic leader with 5+ years of experience heading regulatory functions at a global biopharmaceutical company, adept at navigating US FDA, EU, and other international regulatory pathways for NDAs and clinical trial approvals.

KEY RESPONSIBILITIES:

Global Regulatory Strategy & Submissions

• Develop and execute regulatory strategies for novel biologics, including pre-IND meetings, orphan drug designations, and accelerated approvals
• Lead NDA/MAA submissions for US FDA, EMA, and other agencies, ensuring compliance with ICH guidelines and regional requirements
• Oversee clinical trial applications (CTAs/INDs) and provide input on study design, endpoints, and risk mitigation.

Team Leadership & Cross-Functional Collaboration

• Manage a global team of regulatory professionals, fostering expertise in biologics, ophthalmology, and metabolic disorders
• Partner with R&D, Clinical Development, and CMC teams to align regulatory plans with development milestones.

Compliance & Audit Management

• Ensure adherence to GCP, GMP, and 21 CFR Part 11 standards during regulatory inspections and audits
• Maintain submission timelines using eCTD formats and electronic submission gateways

Team & Project Management

• Mentor QA leaders across sites, fostering a culture of quality and accountability
• Design training programs on GMP/GLP updates, inspection readiness, and root cause analysis methodologies.

Post-Marketing & Lifecycle Management

• Direct post-approval regulatory activities, including variations, renewals, and safety updates
• Monitor evolving regulations (e.g., FDA’s Novel Drug Approvals guidance) and implement proactive compliance measures.

QUALIFICATIONS

• Education: Advanced degree in Life Sciences, Pharmacy, or related field
• Experience:
• 15+ years in regulatory affairs, including 5+ years leading global teams in biopharmaceuticals
• Proven track record in NDAs/BLAs for novel therapies (ophthalmology/metabolic disorders preferred)
• Expertise in FDA/EMA interactions, including Pre-NDA meetings and Advisory Committees.

Skills:

• Proficiency in clinical trial design, statistical analysis, and regulatory writing
• Familiarity with eQMS tools (Veeva, TrackWise) and regulatory intelligence platforms

WHAT WE OFFER

• Opportunities for professional development and career growth
• A collaborative and innovative work environment

WHY JOIN BIOPLUS?
Bioplus offers a unique opportunity to make a significant impact on global healthcare by shaping the commercial success of novel, life-changing therapies. As part of our team, you’ll collaborate with passionate professionals committed to improving patient outcomes worldwide.

EQUAL EMPLOYMENT OPPORTUNITY (EEO) POLICY:

Career opportunities at Bioplus are provided without discrimination on the basis of race, sex/gender, religion/caste/creed, social or ethnic origin, colour, age, differently abled (including physical medical conditions), sexual orientation, domestic partnership status, gender identity or expression, marital status, ancestry, genetic information or any other reason prohibited by laws in India.

REFERENCE: https://bioplus.in / https://www.theialife.com
For further information contact:
Hemant Patel, DGM – Human Resources
Email: recruitment@bioplus.in