Job Summary

Startup Inno is seeking a highly experienced and detail-oriented Remote Regulatory Affairs Manager – Pharma & Biotech to lead and manage global regulatory strategies for pharmaceutical and biotechnology products. This role is critical in ensuring that all products comply with regulatory requirements across multiple markets, including the US, EU, and other international regions.

As a key member of our regulatory leadership team, you will be responsible for driving regulatory submissions, maintaining compliance throughout the product lifecycle, and acting as a strategic advisor to cross-functional teams. This is a fully remote role, offering the opportunity to work with innovative healthcare solutions that impact patients worldwide.

Key Responsibilities

• Develop and implement global regulatory strategies for drug and biotech product development and commercialization.

• Prepare, review, and submit regulatory documents including IND, NDA, BLA, MAA, CTA, and variations.

• Act as the primary point of contact with regulatory authorities (FDA, EMA, MHRA, PMDA, and other global agencies).

• Ensure compliance with international regulatory standards such as ICH, GxP, FDA, and EMA guidelines.

• Provide regulatory guidance to R&D, clinical, quality assurance, manufacturing, and commercial teams.

• Manage regulatory intelligence, monitor regulatory changes, and assess impact on ongoing projects.

• Support audits, inspections, and responses to regulatory queries or deficiencies.

• Oversee labeling, advertising, and promotional material to ensure regulatory compliance.

• Lead regulatory risk assessments and mitigation strategies.

• Mentor and support junior regulatory staff or consultants.

Required Skills and Qualifications

• Strong knowledge of global pharmaceutical and biotech regulatory frameworks.

• Proven expertise in regulatory submissions and lifecycle management.

• Excellent written and verbal communication skills.

• Ability to interpret complex regulatory guidelines and translate them into business strategies.

• Strong project management and organizational skills.

• High attention to detail and analytical mindset.

• Ability to work independently in a remote environment.

• Proficiency in regulatory document management systems (RIMS, eCTD tools).

• Strong stakeholder management and leadership skills.

Experience

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

• 6+ years of experience in Regulatory Affairs within pharma or biotech industries.

• Demonstrated experience with global regulatory submissions (US, EU, and international markets).

• Experience working in a remote or cross-functional global team is a strong advantage.

• Regulatory certifications (RAC or equivalent) are highly desirable.

Working Hours

• Full-time, remote position.

• Flexible working hours with overlap required for global teams (Europe/US business hours).

• Results-driven environment with autonomy and accountability.

Knowledge, Skills, and Abilities

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

• Strong ability to manage multiple regulatory projects simultaneously.

• Strategic thinker with problem-solving capabilities.

• Ability to work under pressure and meet strict regulatory deadlines.

• Excellent collaboration skills in multicultural and cross-functional teams.

• Adaptability to fast-paced and evolving regulatory environments.

Benefits

• Competitive salary package based on experience and location.

• 100% remote work with flexible schedule.

• Health insurance and wellness programs.

• Paid time off, sick leave, and public holidays.

• Continuous learning and professional development opportunities.

• Access to global projects in cutting-edge pharma and biotech fields.

• Performance-based bonuses and career growth opportunities.

Why Join Startup Inno?

At Startup Inno, we are driven by innovation, integrity, and impact. You will join a forward-thinking organization working on transformative healthcare solutions that make a real difference in patients lives. We offer a culture of trust, flexibility, and continuous learning, empowering professionals to grow while contributing to meaningful global projects.

This role provides the unique opportunity to shape regulatory strategies for next-generation pharmaceutical and biotech products in a truly global and remote environment.

How to Apply

Interested candidates are invited to submit their updated resume along with a cover letter highlighting their regulatory experience and global submission expertise.

Please apply through our official career portal or send your application to our recruitment team us with the subject line: Remote Regulatory Affairs Manager – Pharma & Biotech.