Lead Expert, Regulatory A ffairs HNC Singapore

Job title - Lead Expert, Regulatory Affairs HNC Singapore

Location - Singapore

Job model - 2-year contract

We are seeking a highly skilled and experienced Regulatory Affairs Specialist/Manager to manage the re-registration of pharmaceutical drug products in Singapore. The ideal candidate will have hands-on experience in the filing and approval process and be familiar with the relevant country authorities.

At dsm-firmenich, people are at the heart of the company. We are committed to equal employment opportunities and value diversity in the workplace.

Your key responsibilities

• Regulatory Strategy and Planning: Develop and implement regulatory strategies for the re-registration of pharmaceutical products with authorities. Coordinate with cross-functional teams to ensure alignment on regulatory timelines and deliverables.
• Documentation and Submission: Prepare and compile high-quality regulatory submission dossiers in accordance with regulatory requirements. Ensure all documentation is accurate, complete, and submitted within the required timelines.
• Compliance and Monitoring: Monitor regulatory changes and updates to ensure compliance with all relevant guidelines and regulations. Maintain up-to-date knowledge of Indian regulatory requirements and ensure that the company complies with all applicable laws and standards.
• Communication and Liaison: Act as the primary point of contact with authority, and other relevant regulatory authorities. Facilitate communication between internal departments and external stakeholders to ensure a smooth approval process.
• Project Management: Track and manage the progress of all re-registration activities. Provide regular updates to senior management and other stakeholders on the status of approvals.

You bring

• Bachelor's degree in Pharmacy, Life Sciences, or a related field advanced degree preferred
• Minimum of 5-10 years of experience in regulatory affairs within the pharmaceutical industry
• Proven track record of successful regulatory submissions and approvals
• Strong understanding of country guidelines andregulatory requirements.Familiar with Drug Master file.
• Excellent organizational, analytical, and project management skills
• Strong communication skills, both written and verbal.

We bring

• A rich history and a promising future of bold scientific innovation and passionate creation with our customers
• A space to grow by encouraging and supporting curiosity and an open mindset
• A culture that prioritizes safety and well-being, both physically and mentally
• The opportunity to work for a company where sustainability is much more than a claim and is core to our strategy and purpose
• A flexible work environment that empowers people to take accountability for their work and own the outcome
• Barrier-free communities within our organization where every employee is equally valued and respected - regardless of their background, beliefs, or identity

Equal Opportunities Commitment

dsm-firmenich is fully dedicated to inclusion because when people feel engaged and empowered, their creativity and innovation drives unprecedented progress. We aim to build a workplace where opportunity really is equal, so everyone can thrive. We do not discriminate, there's a place for everyone at dsm-firmenich.

dsm-firmenich is an Equal Opportunity and Affirmative Action Employer. dsm-firmenich people are as diverse as our customers. For us that includes a commitment to ensuring equal employment opportunities for all job applicants and employees. Employment decisions are based upon job-related reasons regardless of an applicant's race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, marital status, genetic information, protected veteran status, or any other status protected by law.

We are committed to providing reasonable support for disabled applicants in our recruiting process. Should you need assistance, and are comfortable to share this, please let us know.

About dsm-firmenich

As innovators in nutrition, health, and beauty, dsm-firmenich reinvents, manufactures, and combines vital nutrients, flavors, and fragrances for the world's growing population to thrive. With our comprehensive range of solutions, with natural and renewable ingredients and renowned science and technology capabilities, we work to create what is essential for life, desirable for consumers, and more sustainable for the planet. dsm-firmenich is a Swiss-Dutch company, listed on the Euronext Amsterdam, with opera tions in almost 60 countries and revenues of more than 12 billion. With a diverse, worldwide team of nearly 30,000 employees, we bring progress to life every day, everywhere, for billions of people.