
Expert Regulatory Affairs
6 days 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
1 week 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 weeks 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
3 weeks ago
Bengaluru, India Biocon Biologics Full timeJob Description Position Summary The Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings...
-
Head- Regulatory Affairs
3 weeks ago
Bengaluru, India Michael Page Full timeJob Description - Drive regulatory strategy with global impact at a leading healthtech innovator - Leadership role with strong visibility and growth potential Job Description 1. Regulatory Strategy Development- Define and drive the regulatory vision and strategy for CRM products, aligning with company's business goals. 2. Leadership and Team Management-...
-
Director, Regulatory Affairs
1 week ago
India Friday Plans Full timeJob Description About Us Friday Plansis a technology-driven US-based company evolving from a leading online pharmacy into a vertically integrated pharmaceutical company. Our mission is to develop, manufacture, and commercialize our own portfolio of medicines for the US market. We are seeking a seasoned regulatory leader to navigate this journey and build...
-
Regulatory Affairs Specialist
17 hours ago
Mumbai, India OrbiTouch HR (orbiTouch outsourcing pvt ltd) Full timeJob Description Designation : Regulatory Affairs Specialist Qualifications: Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry Experience : Minimum 4 years of experience in regulatory affairs Salary : good hike on current salary Location : Sandhurst Road Mumbai - Head office Essential Duties and Responsibilities: -...
-
Regulatory Affairs Associate
2 weeks ago
Surat, India Concept Medical Full timeJob Description About Us: Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are...
-
Regulatory Affairs Specialist
4 weeks ago
Mumbai, India Tek Support Full timeJob Description Job Title: Regulatory Affairs Specialist Med/Pharma (Female) Location: Remote Position Overview: We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health...
-
Senior Regulatory Affairs Trainer
4 days ago
Guntur, India Tek Support Full timeJob Description Job Title: Regulatory Affairs Location: Remote Job type: Part-time Job Summary: We are seeking a highly experienced Regulatory Affairs Trainer with over 10 years of expertise in global regulatory compliance, submissions, and lifecycle management across medical devices, pharmaceuticals, biotech, and FMCG sectors. The trainer will be...
-
Regulatory Affairs Specialist
6 days ago
Ahmedabad, Gujarat, India, Gujarat Frisch Medical Devices PVT LTD Full timeJob Title: Regulatory Affairs Junior ManagerLocation: At Ahmedabad Office , Near Thaltej Crossroads Department: RA Reports To: RA Head and Regulatory Department at HO /Director Employment Type: Full TimeOffice hours : 9,30 AM to 6 PMWeek of: Sunday and Saturday Half Day Preferred Gender : M/FExperience: Minimum 2 years Job Summary:We are seeking a...