Strategist - Regulatory Affairs (Canada)

17 hours ago

Bengaluru, Karnataka, India ClinChoice Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Job Summary:


• Experience in Drug identification number (DIN), natural health products (NHP), Dietary Supplement & Cosmetic notification submission and amendment notification to Health Canada.

• Experience in Formula review and approval.

• Evaluation of Ingredient as per Canadian Environmental Protection Act (CEPA) and Ingredient Listing creation including fragrance and flavor certificate review.

• Expertise in Artwork review and drive for approval.

• Change control management from initiation to approval in coordination with cross function teams and drive to implement the changes timely.

• Authoring Product Risk Management of self-care products.

• Experience in product website update and e-commerce activities as per client need.

• Follow client documentation standards and best practices.

Qualifications and desired skills:

• Minimum B.Sc/M. Sc. Chemistry, M. Pharmacy, or related scientific field.

• 7 - 9 years of working experience within regulatory affairs department (pharmaceutical, cosmetics, dietary supplements etc.) with direct accountability for deliverables.

• Work experience in Health Canada regulatory domain would be added advantage.

• Effective and clear communication.

• Quality oriented view with concise writing skills.

• Ability to multi-task effectively and work independently in a remote setting.

• Excellent written and verbal communication skills.

• Familiarity with Health Canada pharmaceutical/supplement guidelines and their scientific interpretation.

  • API Regulatory Affairs

    14 hours ago

    Bengaluru, Karnataka, India Biocon Ltd Full time ₹ 15,00,000 - ₹ 20,00,000 per year

    RoleAPI Regulatory Affairs DMF Filing/ Compilation (Global market)Level Associate Manager / Manager Level:-Required Education/Exp :-Experience Req. : 11 yrs.18 yrs. Qualification:M.Sc. / M.PharmaResponsibilities1. Hands on Regulatory Affairs-API /DMF Filing/ DMF Compilation/ Submission/ Customer Communication etc.2. Compilation and submission of DMFs...

  • API Regulatory Affairs

    17 hours ago

    Bengaluru, Karnataka, India Biocon Ltd Full time ₹ 15,00,000 - ₹ 20,00,000 per year

    Role - API Regulatory Affairs - DMF Filing/ Compilation (Global market) Level - Associate Manager / Manager Level:- Required Education/Exp :- Experience Req.: 11 yrs. - 18 yrs. Qualification: - M.Sc. / M.Pharma Responsibilities 1. Hands on Regulatory Affairs-API /DMF Filing/ DMF Compilation/ Submission/ Customer Communication etc. 2. Compilation and...

  • Executive/ive - Regulatory Affairs (Canada Market)

    14 hours ago

    Bengaluru, Karnataka, India Strides Pharma Science Full time ₹ 8,00,000 - ₹ 12,00,000 per year

    Responsible for compilation and assist team for projects and regulatory submissions by collating documents per regulatory requirements for Canada market for CMC and labelling aspects.Interpret and prepare response to the quality & administrative deficiencies as per regulatory requirement within defined timelines.Develop and implement regulatory CMC...

  • Regulatory Affairs Operations Analyst

    3 weeks ago

    Bengaluru, Karnataka, India BD Full time

    Summary This position is responsible for the creation identification collection and entry of regulatory affairs information of medical devices Support related regulatory affairs activities such as assessment execution and management of regulatory data and information to support all regulatory needs and objectives of the business Requires the analysis...

  • Regulatory Affairs Specialist

    5 days ago

    Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 90,00,000 - ₹ 1,20,00,000

    Regulatory Affairs SpecialistThis role is a great opportunity for individuals with a strong understanding of regulatory affairs and a passion for ensuring compliance. The Regulatory Affairs Specialist will play a critical role in assisting international regulatory teams with navigating evolving business needs in the Indian market.Key...

  • Regulatory Affairs Specialist

    1 week ago

    Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000

    Job Title: Regulatory Affairs Specialist">Job Description:">We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to manage and support regulatory submissions, ensure compliance with global regulatory requirements, and maintain the highest standards of operational excellence in regulatory processes.">Technical skills: Deep...

  • Regulatory Affairs Expert

    3 days ago

    Bengaluru, Karnataka, India beBeeExcellence Full time ₹ 90,00,000 - ₹ 1,20,00,000

    Unlock Regulatory ExcellenceJob Description:As a Regulatory Affairs Specialist, you will play a vital role in ensuring the compliance of our solutions in Healthcare, Life Science, and Electronics. You will work closely with cross-functional teams to define regional regulatory strategies for product changes and serve as an internal point of contact for TA and...

  • Regulatory Affairs Professional

    1 week ago

    Bengaluru, Karnataka, India beBeeRegulatoryAffairs Full time ₹ 8,46,992 - ₹ 12,99,898

    Regulatory Affairs AssociateThis is a critical role that involves providing regulatory support to various departments across the organization. The successful candidate will be responsible for ensuring that all regulatory activities align with business needs.Key Responsibilities:The Regulatory Affairs Associate will be responsible for:Providing regulatory...

  • Regulatory Affairs Professional

    3 days ago

    Bengaluru, Karnataka, India beBeeRegulatory Full time

    Regulatory Affairs ProfessionalThe ideal candidate will be responsible for working closely with international regulatory teams to ensure compliance with Indian regulations.Develop and maintain in-depth knowledge of India's Medical Device Regulations (MDR).Collaborate with cross-functional teams to implement effective regulatory strategies.Identify and...

  • Regulatory Affairs Specialist

    6 days ago

    Bengaluru, Karnataka, India Biocon Biologics Full time

    Position SummaryThe Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations in...