Job Summary

Startup Inno is seeking an experienced and highly motivated Remote Regulatory Affairs Manager – Pharma & Biotech to lead and manage global regulatory strategies across our pharmaceutical and biotechnology product portfolio. This role is critical in ensuring that our products meet all regulatory requirements and are successfully developed, registered, and maintained in compliance with international regulatory standards.

As a key member of our leadership and product development teams, you will provide regulatory guidance from early-stage development through commercialization. You will work cross-functionally with R&D, Clinical, Quality, Manufacturing, and Commercial teams to drive regulatory excellence and accelerate market access in multiple regions.

Key Responsibilities

• Develop and implement global regulatory strategies for pharmaceutical and biotech products.

• Prepare, review, and submit regulatory documentation including IND, NDA, BLA, CTA, MAA, and post-marketing submissions.

• Act as the primary regulatory liaison with health authorities such as FDA, EMA, MHRA, and other global agencies.

• Ensure compliance with applicable regulations, guidelines, and standards throughout the product lifecycle.

• Provide regulatory guidance to internal teams on product development, labeling, clinical trials, and quality systems.

• Monitor changes in regulatory legislation and assess their impact on company products and strategies.

• Support regulatory inspections, audits, and responses to agency queries.

• Lead and manage regulatory timelines, risks, and deliverables for assigned projects.

• Contribute to strategic planning and decision-making at senior management level.

Required Skills and Qualifications

• Bachelors degree in Life Sciences, Pharmacy, Biotechnology, Regulatory Affairs, or a related field (Masters preferred).

• Strong knowledge of global regulatory frameworks (FDA, EMA, ICH, WHO, etc.).

• Proven ability to manage complex regulatory submissions and interactions.

• Excellent written and verbal communication skills in English.

• Strong analytical, organizational, and problem-solving abilities.

• Ability to work independently in a remote environment.

• Proficiency in regulatory documentation systems and compliance tools.

Experience

• Minimum 5–8 years of experience in Regulatory Affairs within the pharmaceutical or biotech industry.

• Hands-on experience with regulatory submissions for clinical and commercial products.

• Experience working in a global or multi-regional regulatory environment is highly preferred.

• Prior experience in a fast-growing startup or innovative environment is an advantage.

Working Hours

• Full-time remote position.

• Flexible working hours with overlap required for global team collaboration.

• Occasional availability for meetings across different time zones.

Knowledge, Skills and Abilities

• In-depth understanding of drug development processes and regulatory pathways.

• Strong project management and leadership skills.

• Ability to translate regulatory requirements into practical business strategies.

• High attention to detail and commitment to quality and compliance.

• Strong stakeholder management and cross-functional collaboration skills.

• Adaptability to fast-changing regulatory and business environments.

Benefits

• Competitive salary package based on experience and market standards.

• 100% remote work with flexible schedule.

• Performance-based bonuses and incentives.

• Health and wellness benefits.

• Professional development and training opportunities.

• Opportunity to work with cutting-edge biotech and pharma innovations.

• Supportive and inclusive company culture.

Why Join Startup Inno?

At Startup Inno, we are building the future of healthcare through innovation and technology. You will be part of a dynamic, forward-thinking team that values expertise, creativity, and impact. This role offers a unique opportunity to shape regulatory strategies for breakthrough products while enjoying the flexibility of remote work and the excitement of a high-growth startup environment.

How to Apply

Interested candidates are invited to submit their updated resume and a cover letter highlighting relevant regulatory experience and achievements. Shortlisted candidates will be contacted for virtual interviews.

Join Startup Inno and play a pivotal role in bringing life-changing pharmaceutical and biotech solutions to the global market.