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Regulatory Affairs Executive

1 month ago

Ahmedabad Gujarat, India SUNTARA COSMETICS Full time

**Responsibilities**
- Review formulations and claims and provide regulatory guidance to ensure full compliance to regulations including mandatory standards.
- Oversight of the preparation and filing of regulatory documents with the FDA and international regulatory bodies; setting the standards for and reviewing all submissions to assure adequacy and accuracy.
- Will scan regulations and mandatory BIS standards and identify opportunities to advocate for revisions in standards towards future fit regulations.
- Will scan competition claims for potential challenges or take learnings to guide Unilever innovations.
- Thoroughly study EU, USA, Gulf Region and ASEAN cosmetic regulations and help in building advocacy for cosmetic reforms.
- Network with other cluster teams and bring regulatory best practices to India.
- Artwork approvals for EU, USA, ASEAN, Gulf region scope.
- Help drive the Digital RA agenda.
- Collaborate closely with business partners to support key business objectives.
- Work with cross functional teams and third parties to obtain regulatory documentation for new and existing products related to testing, production, raw materials, formulas, finished goods, supplier documentation and external certifications.
- Work closely with third party partners and commercial teams to support international registrations, authorizations and product certifications.
- Provide regulatory review of product labels, artwork, manuscripts, information, labels, claims & marketing material to ensure accuracy and compliance.
- Update and maintain Product Information Files (PIF), track documentation, and support key regulatory deliverables to support global registration timelines and product launches.
- Maintain current knowledge of global cosmetic regulations and chemical compliance through ongoing research and data management.
- Compile and organize data for annual reporting requirements and to support product registration requests and cosmetic notification projects.
- Support retailer inquiries, technical documentation requests, and general product questions from various communication platforms.
- Support internal audits and external certification/audits including Vegan and Cruelty Free.

Qualification & Experience

**Education**:
3+ years of combined regulatory affairs experience in the cosmetics or pharmaceutical industry, both domestically and internationally.

Master’s degree in science, with 1-2 years industrial experience or / B. Pharm with at least 4 years of industrial experience in Regulatory Affairs or Cosmetics skin care, hair care, color cosmetics.

**Technical skills**:
Product technical knowledge Understanding of Drugs & Cosmetics regulations and BIS Standards

Experience in global regulatory affairs
- cosmetics, pharmaceuticals, or consumer goods.

Experience with OTC monograph and SPF products, preferred.

Experience with requirements for international product registration.

Experience engaging with Global Health Authorities, including the FDA, Health Canada, UK/European Union and China, preferred.

**Soft skills**:
Teamwork, networking, multi-tasking, good communication (verbal & written) skills, creativity, ability to analyze data and provide logical conclusions

Excellent organization and time management skills to ensure project deadlines are met.

An analytical and problem-solving mindset.

Ability to both understand and write technical documentation is required.

A good command of English is fundamental. Strong interpersonal, written and verbal communication and analytic skills.Strong judgement, attention to detail and the ability to lead multiple projects simultaneously

Well-organized and able to prioritize in a fast-paced environment, demonstrating dedication and creativity.

Previous experience in preparing documents for relevant authority submissions (Clinical Trial, Chemistry & Manufacturing, and or Product Registration).

.Ability to coordinate and analyze technical data and identify issues or gaps.

Strong Microsoft Office skills, including fluency in Microsoft Excel.

Self-motivated and committed to a team approach.

Ability to provide innovative solutions within the boundaries of regulation.

Bachelor's degree in scientific discipline or relevant field, or equivalent.

**Benefits**:

- Cell phone reimbursement
- Flexible schedule
- Food provided
- Health insurance
- Internet reimbursement
- Paid sick time
- Provident Fund

Schedule:

- Day shift

Supplemental pay types:

- Performance bonus

**Experience**:

- total work: 3 years (preferred)

Work Location: In person