Regulatory Affairs

3 weeks ago


Remote, India Comtec IT Services Full time

Regulatory Affairs Associate Manager

Location: Remote

Duration: 7 months

RESPONSIBILITES:

- Validate product composition, ingredient lists, develop nutritionals and advise on/approve regulated claims for compliance under US laws and regulations
- Participate in validation of marketing campaigns and review of associated materials
- Approve packaging artwork/graphics and label claims for brands supported
- Contribute regulatory perspective in brand and cross-functional meetings and/or legal weekly meetings to mitigate regulatory risks and support business growth and innovation
- Identify challenges for upcoming projects and innovations and advise business with solutions that meet regulatory requirements
- Support roll outs of new food and packaging regulations
- Train key stakeholders on relevant regulatory updates
- Support comments to new rules, trade association work, and relevant regulatory committee projects
- Support the management of crises, as needed
- Review product and ingredient specifications and documentation
- Support Export team in certain types of regulatory product information requests
- Develop claim language and liaise with relevant stakeholders in approval process (includes working with key functions such as Nutrition Science, Scientific Affairs, Research and Innovation, and Legal)
- Assess changes to regulations and impact to relevant portfolio of products
- Review new ingredients for GRAS status and/or regulatory authorization
- Engage with suppliers on relevant regulatory compliance topics and/or adherence to new regulations
- Position will support Yogurt Business Unit and may support additional businesses in the future

PREFERRED CANDIDATE QUALIFICATIONS:
Education and Experience
- Bachelor’s Degree in Food Science, Biological Sciences, Nutrition, or related scientific field
- 3+ years of experience in a Regulatory Affairs (or related scientific) role with a CPG food manufacturer or ingredient supplier; experience in food labeling for nutrition-focused products (dairy, plant-based foods, beverages, cereals, bars, shakes, meals)
- Familiarity with SAP nutrition database and labeling systems, or similar systems such as Genesis

Knowledge, Skills and Abilities:

- Knowledge of food composition as it relates to food labeling, nutrition, and ingredient composition
- Scientific proficiency and ability to understand science-based regulations and communicate scientific topics to various functions, including marketing and legal
- Ability to handle complexity, multiple projects and requests, and short timelines
- Strong drive for results and ability to bring projects to completion
- Good judgment, decisiveness, and interpersonal skills
- Comfortable with labeling databases, computer software, Microsoft Excel, and other systems
- Detail oriented, accurate and excellent record keeping skills
- Comfortable with ambiguity and problem solving
- Strong written and oral communication skills

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

**Salary**: ₹25.00 - ₹27.00 per hour

Schedule:

- Day shift

**Experience**:

- CPG: 2 years (preferred)
- food labeling for nutrition-focused products: 2 years (preferred)
- Regulatory Affairs: 2 years (preferred)

Work Location: Remote



  • Remote, India Parexel Full time

    As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...


  • REMOTE, India Parexel Full time

    Senior Regulatory Affairs AssociateAround 4-8 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologics) in various markets.Good understanding of regulatory framework, including regional trends, for various types of applications and proceduresContribute to preparation...


  • REMOTE, India Parexel Full time

    Job Description:Relevant experience in regulatory package preparation, compilation and submission to Health Authorities in various markets with focus on EU countries.Working knowledge of EU regulatory procedures including adaptability to strict Health Authority and Sponsor timelines for completing submissionsKnowledge of EU country regulationsAble to...


  • Remote, India ProductLife Group Full time

    **Required education**: Degree in relevant life science discipline **Required Experience**: 2-4 years relevant experience **Required Technical Skills**: - Lifecycle maintenance experience - Providing support during external and unannounced audits. - Responding to internal requests for technical and/or regulatory information. - Preparation and submission...


  • Remote, India Innovaderm Research Full time

    The Regulatory Project Assistant (RPA) is responsible for providing project administrative support to the regulatory project team members (regulatory affairs, eTMF operations). The RPA also supports activities within the regulatory website Clinical Trial Information System (CTIS) ensuring completeness and timely entry of information for EU submissions. The...

  • 118

    1 month ago


    Remote, India ProductLife Group Full time

    **Responsibilities**: - To contribute to the production of client administrative documents and reports to be included in regulatory submissions - Compile, or supervise the compilation of regulatory dossiers in accordance with national requirements - LCM, Systems Management and Administration - Document and track regulatory submissions and regulatory...


  • Remote, India Syneos Health Clinical Full time

    **Description** **Medical Writer II** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers...


  • Remote, India IQVIA Full time

    Job Overview Engage in peer-to-peer scientific exchange with ability to understand, interpret, communicate complex scientific data and information effectively to KOLs/HCPs Essential Functions - Engage in peer-to-peer scientific exchange with ability to understand, interpret, communicate complex scientific data and information effectively to KOLs/HCPs -...


  • Remote, India Syneos Health Clinical Full time

    **Description** **Principal Biostatistician** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient...


  • Remote, India Syneos Health Clinical Full time

    **Description** **Principal Statistical Programmer** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the...