
Expert Regulatory Affairs
1 day ago
Job Title **:Expert Regulatory Affairs ( Contract for 18 months)**
Job Type : Remote / WFH / Hybrid
Location : India
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.
**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 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
-
Regulatory Affairs
5 days ago
India Sunrise Remedies Full timeSunrise Remedies Job Opening for Regulatory Affairs (RA). **Experience**: Minimum 2 Years **Industries**: Pharmaceutical Company **Education**: B.Sc. / M.Sc / B.Pharm / M.Pharm **Job Location**: Santej Ahmedabad. **Key Responsibilities**: - Regulatory Affairs Specialists assist in obtaining and maintaining government approval for drugs, medical devices,...
-
Regulatory Affairs Specialist
4 days ago
India Frisch Medical Devices PVT LTD Full timeJob Title: Regulatory Affairs Junior ManagerLocation: At Ahmedabad Office , Near Thaltej CrossroadsDepartment: RAReports To: RA Head and Regulatory Department at HO /DirectorEmployment Type: Full TimeOffice hours : 9,30 AM to 6 PMWeek of: Sunday and Saturday Half DayPreferred Gender : M/FExperience: Minimum 2 yearsJob Summary:We are seeking a proactive and...
-
Regulatory Affairs Specialist
2 weeks ago
India beBeeregulatory Full time ₹ 12,00,000 - ₹ 20,00,000Regulatory Affairs Specialist">The Regulatory Affairs team is seeking a highly skilled and experienced specialist to support the management of regulatory submissions for healthcare products across diverse geographies.">Key Responsibilities:">Management and coordination with vendors of technical and legal requirements for obtaining marketing authorization...
-
Regulatory Affairs Executive
1 day ago
India Kumar Organic Products Full time**Entry Level**: **Education**: Chemistry background - BSc - Chemistry / MSc - Chemistry **Notice Period**: Immediate - 30 days **Job type**: Full Time **Industry**: Specialty chemicals, Beauty & Personal Care, Pharmaceutical **Job location**: - India (Head Office)_ **Salary**: Best In Class **Benefits** Group Medical Insurance Group Accidental...
-
Regulatory Affairs Manager
2 days ago
India eteraflex connects Full time ₹ 9,00,000 - ₹ 12,00,000 per yearWe are seeking an experienced Clinical Trial Regulatory and Operations Manager based in Delhi/NCR who will ensure the timely initiation and successful execution of clinical trials. The ideal candidate will have extensive knowledge of India's clinical trial regulatory landscape, CDSCO submissions, import licensing, and operational oversight of clinical...
-
Regulatory Affairs Supervisor
7 days ago
India Guerbet Full time**At Guerbet, we build lasting relationships so that to enable people to live better**. This is **Our Purpose.** We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95...
-
Senior Regulatory Affairs Specialist
6 days ago
India vueverse. Full timeKey Responsibilities:- Lead and manage CMC regulatory activities for USFDA submissions including ANDA preparation, review, and filing.- Oversee compilation and submission of Annual Reports, amendments, and deficiency responses.- Interface with cross-functional teams including Quality Assurance, Production, and R&D to gather required documentation and data.-...
-
Senior Regulatory Affairs Specialist
4 weeks ago
India vueverse. Full timeKey Responsibilities:Lead and manage CMC regulatory activities for USFDA submissions including ANDA preparation, review, and filing.Oversee compilation and submission of Annual Reports, amendments, and deficiency responses.Interface with cross-functional teams including Quality Assurance, Production, and R&D to gather required documentation and data.Review...
-
Regulatory Consultant
3 days ago
India Metina PharmConsulting Pvt. Ltd. Full time US$ 90,000 - US$ 1,20,000 per yearPosition – Regulatory ConsultantCompany InformationWe are a reputed Pharmaceutical Consulting firm working in the area of GMP and Global Regulatory Affairs. We have our head office in Mumbai and subsidiaries in Singapore and Australia, and currently establishing in Europe. We have been providing high quality & timely consulting service to the...
-
Regulatory Affairs Specialist
6 days ago
Pydibimavaram, Andhra Pradesh, India Dr Reddy's Laboratories Limited Full time ₹ 1,04,000 - ₹ 1,30,878 per yearCompany Description Dr. Reddy's Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can't Wait.We started in 1984 with a modest investment, 20...