DSM
3 days ago
Job Title : Expert Regulatory Affairs ( Contract for 18 months)
Job Type : Remote / WFH / Hybrid
Location : India
We are seeking a highly skilled and experienced Senior Expert, Regulatory Affairs to manage the re-registration of pharmaceutical drug products in APAC. The ideal candidate will have hands-on experience in the filing and approval process and be familiar with the country authorities in APAC.
At dsm-firmenich, being a force for good is not optional. Diversity, Equity & Inclusion is a shared responsibility woven into our daily work, benefiting to our People, Customers & Communities and driving business value. Equal access to opportunities is a given, belonging is a shared feeling, authenticity is celebrated.
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 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/consultant, 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 7-10 years of experience in regulatory affairs within the pharmaceutical industry.
• Proven track record of successful regulatory submissions and approvals
• Strong understanding of country guidelines and regulatory requirements.
• Excellent organizational, analytical, and project management skills.
• Strong communication skills, both written and verbal.
• Experience with legal entity changes and their impact on regulatory approvals.
• Familiarity with electronic submission systems and regulatory databases.
The application process.
Interested in this position? Please apply on-line by uploading your resume in English via our career portal. For further information, please contact Avinash Pandey, Talent Acquisition Manager (avinash.pandey@dsm.com)
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; theres 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 applicants 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 worlds 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 operations 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