Senior Manager Regulatory affairs and Product Compliance
1 week ago
As a regulatory affairs manager, you'll be the crucial link between the company, its products, and regulatory authorities. You'll combine your knowledge of scientific, legal, and business issues to ensure that the personal care products developed, manufactured, or distributed by the company, meet the required legislation, and are fit for the purpose.
Key duties and responsibilities of the role
Ensuring compliance of products with regulations set by the cosmetic regulatory agencies as per country-wise requirements for USA/EU/Asia.
• Studying legal documents and collating information in a variety of formats.
• Advising scientists and manufacturers on regulatory requirements.
• Providing strategic advice to senior management throughout the development of a new product. • Keeping up to date with changes in regulatory legislation and guidelines and appraising the related teams and the management about them.
• Responding to queries from regulatory bodies of different geographies.
• Outlining requirements for labelling, storage and packaging.
• Maintain and support procedures to ensure the compliance of all cosmetic products and packaging.
• Developing and writing clear arguments and explanations for new product licenses and renewals. • Preparing submissions of license variations and renewals to strict deadlines
• Preparing product dossiers and PIF (Product Information File) with the help of internal teams or external agencies or both.
• Undertaking and managing regulatory inspections.
• Reviewing company practices and provide advice on changes to systems.
• Liaise with, and make presentations to, regulatory authorities.
• Negotiating with regulatory authorities for marketing authorization.
• Taking part in the development of marketing concepts and approving packaging and advertising before a product's release concerning content and claims.
Specific skills or competencies needed for success in the role
You'll be required to have,
• Understanding of both legal and scientific matters.
• ability to take in complex technical information and make sense of it.
• The ability to grasp new concepts quickly and to assimilate and evaluate scientific data.
• Analytical and problem-solving skills.
• Written and oral communication skills.
• Attention to detail.
• Strong negotiation skills.
• IT skills, particularly in relation to using databases and familiarity with commercial software.
• The ability to work under pressure and to strict deadlines.
• The confidence to report to management.
• Teamworking skills and the ability to lead and motivate others.
• Project-management skills.
• Good time management.
• Integrity and a professional approach to work
Personal qualities or attributes that are important for the role
• Teamwork
• Leadership
• Problem-solving abilities
• Self-driven approach
• Integrity
Special working conditions
Travel is only conditional, primarily seating will be at corporate R&D centre.
Qualifications, Skills & Experience Qualifications
Any postgraduate degree from the list below will be the minimum qualification required.
Any diploma certifications in regulatory affairs, ISO etc is desirable.
A postgraduate degree like M Pharma, Drugs and Regulatory Affairs, will be highly valued.
• Biochemistry,
• Biology,
• Biomedical science,
• Biotechnology
• Chemistry,
• Medicine,
• Pharmacology,
• Pharmacy or cosmetology.
Skills
• Should be well versed primarily with US FDA, EU regulatory requirements. China, South Korea, Singapore, Japan, and Middle-Eastern countries, cosmetic regulations, and compliances in addition will be preferred.
• PIF ( Product Information File), and CPNP ( Cosmetic Products Notification Portal) files.
• Good knowledge of the Indian Drug and Cosmetic Act especially on Schedule S Standards & GMP (must) and FSSAI (desirable).
• Knowledge of US FDA 21 CFR and ISO 22716 will be an added advantage and is desirable.
Experience required for the role:
• A minimum of 10- 15 years of experience is required as a senior regulatory affairs manager in the pharmaceutical with a minimum 5-7 years in the cosmetics industry.
• Having faced US FDA / MHRA audits in a senior capacity/ lead auditee will be highly valued and will give you an advantage
Company Website :
-
Manager - Regulatory Affairs and Compliance
4 months ago
Gurgaon, India 3M Full time3M has a long-standing reputation as a company committed to innovation. We provide the freedom to explore and encourage curiosity and creativity. We gain new insight from diverse thinking, and take risks on new ideas. Here, you can apply your talent in bold ways that matter. Job Description: About the Role: Reporting into the Asia RAQC Manager, you...
-
Gurgaon, India Transformative Learning Solutions Full timeJob Summary As a regulatory affairs manager, you'll be the crucial link between the company, its products, and regulatory authorities. You'll combine your knowledge of scientific, legal, and business issues to ensure that the personal care products developed, manufactured, or distributed by the company, meet the required legislation, and are fit...
-
Head of Regulatory Affairs, India
1 week ago
Gurgaon, India Takeda Pharmaceuticals Full timeBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my...
-
Head of Regulatory Affairs, India
1 week ago
Gurgaon, India Takeda Pharmaceutical Full timeBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...
-
Regulatory Affairs Executive
3 months ago
Gurgaon, India career and job Full timeREQUIRE REGULATORY AFFAIRS EXECUTIVE experience in medical devices **Job Types**: Full-time, Regular / Permanent **Salary**: ₹75,000.00 - ₹95,000.00 per month Schedule: - Day shift **Education**: - Bachelor's (preferred) **Experience**: - total work: 5 years (preferred) **Speak with the employer** +91 9136838735
-
Sr Executive
6 days ago
Gurgaon, India MAISON D' AURAINE Full timeAbout the Company: MAISON D' AURAINE is a conglomerate with a portfolio of premium brands in hair, beauty, and personal care. We started our journey in 2014 by partnering and launching "Gkhair" in India and over the course of the last 10 years, we have cemented our position as the leader in this category servicing 15000 salons across 300 cities of...
-
Associate Director, Regulatory Affairs
1 month ago
Gurgaon, Haryana, India MSD Full timeJob DescriptionAssociate Director – Regulatory AffairsOur Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant...
-
Officer - Regulatory Affairs (Agrochemical)
2 months ago
Gurgaon, India Om Sai Global HR Services Full time_**Roles and Responsibilities**_ - To have a clear understanding of regulatory guidelines and data requirement for pesticide export. - Collect and coordinate information to prepare regulatory documentation for submission to regulatory agencies - Coordinating for Domestic and International Product registration. - Preparation of Product related Dossiers. -...
-
Associate Director, Regulatory Affairs
1 month ago
Gurgaon, India MSD Full timeJob DescriptionAssociate Director – Regulatory AffairsOur Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant...
-
Senior Manager
1 week ago
gurgaon, India Home Credit India Full timeObjectiveThe job holder is responsible for ensuring compliances with all the laws applicable to the Company, provision of legal advisory services whenever required and ensuring effective compliance, contract management, providing legal support in designing various products/ processes and resolving legal issues.Key ResponsibilitiesCapable of handling company...
-
gurgaon, India Aviva India Full timeFormal QualificationsL.L.B. and / or Company Secretary / Insurance Post Graduate / Chartered Accountant /AIII / FIII /Membership of associations such as CIA and CISAExperienceCompetence in interpreting insurance laws and regulationsUnderstanding of insurance industry and regulations5-7 years of relevant work experience in the life /non-life/health insurance...
-
Executive – Govt Affairs
7 days ago
gurgaon, India Olympus Medical Systems India Pvt Ltd Full timeThe role exists to establish Olympus reputation as a effective participant to the government and other stakeholders in country’s healthcare ecosystem in advancing standards of care and access to healthcare in rare and underserved disease conditions. Incumbent needs to establish and cultivate relations with central and state policy-makers, key opinion...
-
Taxation and Compliance Lead
3 days ago
Gurgaon, India Takeda Full timeDescriptionROLE PURPOSEThe role exists to manage compliances for Direct and Indirect Taxes. Engage and mentor the teams in accounting and taxes. The role requires the person to manage and be responsible for NPPA compliances such as filing quarterly statements, filing applications for price increase and other related compliances. Work closely with business...
-
Account Manager-Public Affairs
2 months ago
Gurgaon, India Burson Full timeBursonis looking forAccount Managerfor ourGurugramOffice .The individual will join our Public Affairs & Advocacy team. Our PA team comprises of lawyers, communication specialists, research experts and journalists as well as senior policy advisors who have worked with the Government for many years.As an Account Manager in the Public Affairs division, you are...
-
Executive - Govt Affairs
6 days ago
Gurgaon, India Olympus Medical Systems India Pvt Ltd Full timeThe role exists to establish Olympus reputation as a effective participant to the government and other stakeholders in country’s healthcare ecosystem in advancing standards of care and access to healthcare in rare and underserved disease conditions. Incumbent needs to establish and cultivate relations with central and state policy-makers, key opinion...
-
Senior Market Access Manager
2 days ago
gurgaon, India Takeda Full timeDescription ROLE PURPOSE As a Senior Market Access Manager for Vaccines, you will play a critical role in co creating robust public market access strategy and implementing market access strategies to ensure optimal patient access , private insurance, corporate accounts and public reimbursement for our vaccine portfolio. You will work closely...
-
Senior Market Access Manager
3 weeks ago
Gurgaon, India Takeda Full timeDescription ROLE PURPOSE As a Senior Market Access Manager for Vaccines, you will play a critical role in co creating robust public market access strategy and implementing market access strategies to ensure optimal patient access , private insurance, corporate accounts and public reimbursement for our vaccine portfolio. You will work closely with...
-
Product Manager
1 week ago
gurgaon, India Antara Senior Care Full timeJob Title: Product ManagerRole Summary:You will be responsible for product planning and execution throughout the product lifecycle, including gathering and prioritizing product and customer requirements, defining the product vision, and working closely with sales, marketing, and support to ensure revenue and customer satisfaction goals are met. You will also...
-
Head of Public Policy
1 week ago
gurgaon, India the private office Full timeLocation : Gurgaon – National Capital RegionReports To : Board of DirectorsJob OverviewThe Head of Public Policy and Legal will be responsible for leading and managing the company's public policy initiatives and legal matters. This role will involve developing and implementing strategies to integrate the organisation with relevant public policies, meeting...
-
Taxation and Compliance Lead
3 weeks ago
Gurgaon, India Takeda Full timeDescription ROLE PURPOSE The role exists to manage compliances for Direct and Indirect Taxes. Engage and mentor the teams in accounting and taxes. The role requires the person to manage and be responsible for NPPA compliances such as filing quarterly statements, filing applications for price increase and other related compliances. Work closely...