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Senior Manager Regulatory affairs and Product Compliance

2 months ago

Gurgaon, India Transformative Learning Solutions Full time

Job 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 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

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