Regulatory Affairs

**Job Description Form**

Consumer - Regulatory Affairs

**Department / Project **( OTC+Cosmetics+Food and **Job Title **Team Lead

Dietary Supplements)

**Duties and Responsibilities**

**Regulatory Strategist/ Specialist**:

- Complete Regulatory Support - providing regulatory services/ support for client projects for assigned markets.
- Markets assigned could be few or all from the following:

- Should be well versed with country specific regulations and standards or at least know-how on obtaining information from relevant resources/ Freyr internal teams or Global/ regional offices.
- Promptly gathering RA/ RI information from database or resources for projects.
- Advise and inputs on Regulatory strategy/ Pathway of various products in scope.
- Devising Regulatory strategy right from the product development to lifecycle management to addressing all submission requirements and to comply with the mandatory requirements.
- Identification of applicable product category/ product classification (Nutraceuticals/Health
Supplements/ OTC/ Cosmetics)
- Advising on the given/ specified claims for products ( as a part of claims review) basis claims guidelines for the markets.
- Label review and Formula review ( ingredient assessment) of products in scope.
- Assessment of current product compliance against registration requirements.
- Identifying risks and challenges in registration and recommend mitigation approach, alternate route
- Addressing queries from HA (Health authority) within the stipulated timeframe.
- Promptly acknowledging and suitably addressing regulatory queries and issues within Team / globally, resulting utmost resolution.
- Effective management of resource and timeline - Manage regulatory resource and track registration timelines to ensure plans are aligned to commercial objectives
- Managing the given project independently for delivery and project Management aspects. Delivery schedule of projects should be managed effifiently without any delays from team.
- Sharing of information pertaining to latest, updated or New Guidelines/Regulations etc., published by the Regulatory Authorities, trade associations, journals, news inorder to keep them abreast of latest development and guide the team on the impact, if any, due to the changes in regulatory environment and way forward to handle the changes effectively - for the assigned markets
- Review of all delivery reports of the assigned markets projects.
- Responding to queries/ requests in timely manner (within team and cross functional teams)
- Participating in various meetings/ calls of team in India/ globally on behalf of client for given markets
- Preparing regulatory overview presentations ( as per requirement) for internal team, Global team members / clients
- Training team as and when required, on Consumer RA for specific markets - as and when needed.
**Registration operations support**
- Complete support to teams (Mfg, R&D, Mktg, QA/QC, packaging / design, advertising and promotion, licensing, imports etc), Estimate lead times expected for registrations basis compliance and risks,
Support building comprehensive documentation required for registration, Manage submissions to relevant authorities, Liaison with relevant authorities & agencies for queries / Notices/ notifications
- Artwork review and approval, Review and approval of promotional and advertising material, packaging and label claims of new developments
- Overseeing/ Coordinating for Line extension/ product licence renewals/ New variants, License transfer or site change documentation
- Reviewing complete documentation for Regulatory submission and quality compliance
- Monthly Planning of dossier submission, allotment of tasks to all RA team members
**Other required skills**:

- Timesheet management and Project report updates/ status updates
- Flexibility in woring hours - to attend client calls in required market timezone.
- Good communication skills ( verbal and written, both)
- Exposure with MS Office (Excel, Word, Powerpoint, MSTeams /Skype/Google/Webex/ Gotomeeting app, Outlook, etc.,)
- Team management (team support, mentoring, Review, Appraisal and other team meetings)
- Strong interpersonal and relationship-building abilities
- Effective presentation skills
- Sound decision-making
- Ability to successfully manage multiple competing priorities while maintaining attention to detail

**Qualifications**:

- Bachelor's or Master’s Degree in Science or Pharmacy or Biotechnology with a minimum of 4-5 years of experience in regulatory affairs function ( Pharma, Food and Cosmetics/ Personal care products)
- QA and compliance knowledge and experience, would be an added advantage but not mandatory
- Global exposure to various projects for regulatory supportcountries like USA, EU, Canada, India, UK,
ANZ, SE Asean markets will be an added advantage.

**Job Types**: Full-time, Permanent

**Salary**: $300,000.00 - $450,000.00 per month

**Language**:

- English (required)