Regulatory Affairs Officer

5 days ago

Wagholi Pune Maharashtra, India Statistical Pharma Full time

**Regulatory Affairs Officer Duties & Responsibilities**

The role and function of a Regulatory Affairs Officer includes the following duties and responsibilities:

- Preparing submissions of licence variations and renewals to strict deadlines;
- Ensuring that a company’s products comply with regulations;
- Keeping abreast of international legislation, guidelines and customer practices in all countries that the company is exporting to;
- Negotiating with regulatory authorities for marketing authorisation;
- Specifying storage, labelling and packaging requirements.
- Collecting, collating and evaluating scientific data that has been researched by colleagues;
- Developing and writing clear arguments and explanations for new product licences and licence renewals;
- Planning and developing product trials and interpreting trial data;
- Advising scientists and manufacturers on regulatory requirements;
- Reviewing company practices and providing advice on changes to systems;
- Liaising with, and making presentations to, regulatory authorities;
- Monitoring and setting timelines for licence variations and renewal approvals;
- Working with specialist computer software and resources;
- Writing clear, accessible product labels and patient information leaflets;
- Providing strategic advice to senior management throughout the development of a new product;
- Project managing teams of colleagues involved with the development of new products;

**Salary**: ₹111,861.27 - ₹643,812.53 per year

**Benefits**:

- Internet reimbursement

Schedule:

- Day shift

Supplemental pay types:

- Performance bonus

Ability to commute/relocate:

- Wagholi, Pune, Maharashtra: Reliably commute or planning to relocate before starting work (required)

**Education**:

- Higher Secondary(12th Pass) (preferred)

**Experience**:

- total work: 1 year (preferred)

  • Regulatory Affairs Officer

    2 weeks ago

    Manjri, Pune, Maharashtra, India Fusion Market Research Full time

    _**Duties/Responsibilities**:_ - Works in the regulatory affairs department on assigned projects. - Coordinates with product development and/or research and development teams to request, develop, and prepare required data and reports to be submitted to regulatory bodies and agencies. - Collaborates with key staff from Planning, Product Development,...

  • Regulatory Affairs Officer

    3 days ago

    Mumbai, Maharashtra, India Orbitouch Outsourcing Pvt ltd Full time

    Designation : Regulatory Affairs Specialist Qualifications: Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry Experience : Minimum 8 years of experience in regulatory affairs Salary : As per industry Location : Sandhurst Road Mumbai - Head office **Job Summary**: **Essential Duties and Responsibilities**: -...

  • Regulatory Affairs Officer

    6 days ago

    Santacruz West, Mumbai, Maharashtra, India Globofarm LLP Full time ₹ 30,00,000 - ₹ 35,00,000 per year

    Job Profile – Regulatory Affairs (FSSAI)PositionRegulatory Affairs – FSSAI ComplianceLocation Santacruz West mumbaiReports ToHead – DirectorRole PurposeTo ensure that all nutraceutical, pharmaceutical ingredients, oils, botanicals, and food products marketed/imported/distributed by the company are fully compliant with FSSAI regulations and other...

  • Regulatory Affairs Officer

    7 days ago

    Mumbai, Maharashtra, India MEDVARSITY ONLINE LIMITED Full time

    Job Title: Senior Executive - Regulatory Affairs UK/IE/MT Department: Regulatory Affairs Grade Level: P-2 Reports to: Manager / Sr. Manager - Regulatory Affairs Number of Reports: NONE Location: Mumbai **Main purpose of role**: To ensure adequate and prompt life cycle maintenance activities for Marketing Authorization’s (MA) held based on portfolio...

  • Regulatory Affairs Executive

    1 week ago

    Mumbai, Maharashtra, India R. Wadiwala Sec Pvt Ltd Full time

    Designation : Regulatory Affairs Specialist - Qualifications : Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry - Experience : Minimum 2-5 years of experience in regulatory affairs - Salary : Good Hike on Current CTC - Location : Sandhurst Road Mumbai - Head

  • Regulatory Affairs Executive

    2 weeks ago

    Deccan Gymkhana, Pune, Maharashtra, India Zetta Women Full time

    **Job Title**:Pharmaceutical Regulatory Affairs Executive **(Intern)** **Location**: Pune, India **Duration**: 9 months (Advanced Certification) + 3 months (On the Job Internship) **Job Summary**: **Key Responsibilities**: 1. Attend classes on weekends (Saturdays and Sundays) 2. Complete coursework, assignments, and projects 3. Participate in...

  • Regulatory Affairs Officer

    1 week ago

    Mumbai, Maharashtra, India TheTalentforte.com Full time

    We are looking for **REGULATORY AFFAIRS OFFICER** - BPharma / MPharma / BSc / MSc - 1 - 2 years experience in Regulatory Affairs or relevant (_Freshers please do not apply_) - English Speaking is a Must - Work Timings: Mon to Sat, 10am to 6pm (2nd & 4th sat off) - Salary 18 to 22000 PM, depending on suitability **Should be able to handle**: 1. Preparation,...

  • Regulatory Affairs Executive

    7 days ago

    Pune, India Salahkaar consultants Full time

    Job Title - Regulatory Affairs Experience - 3 -5 years in finished doses form Location - Pune Industry - Leading Pharma Industry Roles and Responsibilities To coordinate and preparation of Quality Agreements. Maintain the required documents for Regulatory Affairs. Liaising with customers and regulatory authorities regarding quality matters, including...

  • Regulatory Affairs Analyst

    15 hours ago

    Pune, Maharashtra, India Varex Imaging Corporation Full time ₹ 4,00,000 - ₹ 12,00,000 per year

    To apply to a Varex Imaging position, please create an account and sign-in.CURRENT VAREX IMAGING EMPLOYEES: Please apply by logging into your internal Workday Account.SummaryVarex Imaging Regulatory Affairs Analyst participates in the compliance of medical and industrial x-ray products. The Regulatory Affairs Analysts is a key player in a cross-functional...

  • Regulatory Affairs

    24 hours ago

    Mumbai, Maharashtra, India Clini launch Business Solutions Full time

    **Position: Sr. Executive/Asst. Manager/Deputy Manager-Regulatory Affairs (Domestic).** **Location: Andheri, Mumbai.** **Qualification: M. Pharm. (Experienced preferred).** **JOB DESCRIPTION - Regulatory Affairs (Domestic)** The role will involve expertise in D & C Act and Rules as well as FSSAI regulations with experience in FDA related activities....