Regulatory Affairs Associate

3 days ago

Mumbai Maharashtra, India Fusion Market Research Full time

_**Responsibilities**:_

As a regulatory affairs officer, you'll need to:

- ensure that a company's products comply with the regulations of the regions where they want to distribute them
- keep up to date with national and international legislation, guidelines and customer practices
- respond to queries from medical bodies like the Medicines and Healthcare products Regulatory Agency (MHRA)
- collect, collate and evaluate scientific data from a range of sources
- develop and write clear arguments and explanations for new product licences and licence renewals
- prepare submissions of licence variations and renewals to strict deadlines
- monitor and set timelines for licence variations and renewal approvals
- work with specialist computer software and resources
- write clear, accessible product labels and patient information leaflets
- plan and develop product trials and interpret trial data
- advise scientists and manufacturers on regulatory requirements
- provide strategic advice to senior management throughout the development of a new product
- project manage teams of colleagues involved with the development of new products
- oversee product trials and interpret trail data
- undertake and manage regulatory inspections
- review company practices and provide advice on changes to systems
- liaise with, and make presentations to, regulatory authorities
- negotiate with regulatory authorities for marketing authorisation
- take part in the development of marketing concepts and approve packaging and advertising before a product's release.

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

Pay: ₹315,023.20 - ₹574,442.11 per year

**Benefits**:

- Health insurance
- Life insurance
- Paid sick time

Schedule:

- Day shift
- Monday to Friday

Supplemental Pay:

- Joining bonus
- Performance bonus
- Yearly bonus

**Experience**:

- total work: 1 year (preferred)

Work Location: In person

  • Associate, Regulatory Affairs

    2 weeks ago

    Mumbai, Maharashtra, India Colgate-Palmolive Full time

    Established in 1806 as a small soap and candle business in New York City Colgate-Palmolive is now a truly global company with products sold in over 200 countries and territories under such internationally recognized brand names as Colgate Palmolive Softsoap Irish Spring Protex Sorriso Kolynos elmex Tom s of Maine Sanex Ajax Axion Soupline Haci Sakir Suavitel...

  • Associate - Regulatory Affairs

    6 days ago

    Mumbai, India Colgate-Palmolive Full time

    Relocation Assistance Offered Within Country 139208 - Mumbai, Maharashtra, India ***: **About Colgate-Palmolive**: Do you want to come to work with a smile and leave with one as well? In between those smiles, your day consists of connecting with others across the world, full of stimulating discussions, and making impactful contributions! If this is how...

  • Regulatory Affairs Associate

    2 weeks ago

    Thane H.O, Thane, Maharashtra, India Planet Science Full time

    **About Us**: An established player in the B2B Pharma raw material space has recently launched an exciting new E-commerce platform **- CLYZO** **Position - Regulatory Affairs Associate.** An organization with a reputed history of 10+ years in the Pharma raw material industry, dealing in excipient products is looking for Regulatory Affair Executive having...

  • Executive - Regulatory Affairs - Mumbai

    3 days ago

    Mumbai, Maharashtra, India Domnic Lewis Pvt. Ltd Full time

    **Executive - Regulatory Affairs - Mumbai**: **Domnic Lewis has been mandated to hire for Executive - Regulatory Affairs - Mumbai** **Position Title**: Executive - Regulatory Affairs **Grade**: C **Reports to**: Lead/Manager - Regulatory Affairs **Position Purpose**: - Monitor and report the status of all product licenses in a timely and accurate manner -...

  • Regulatory Affairs

    2 weeks 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....

  • Regulatory Affairs Executive

    1 week ago

    Mumbai, India Morpheus Human Consulting Full time

    Reference Code: - 319-58 - Job Title: **Regulatory Affairs Executive - Animal Health Care - Mumbai** - Category: - Manufacturing - Job Description: - Job Title: Regulatory Affairs Executive - Vile Parle - Mumbai - **Job Description**: - Managing regulatory affairs of the organization & its subsidiaries / associates. - Liaising with regulatory bodies like...

  • Regulatory Affairs Executive/ Veterinary Pharma

    1 week ago

    Mumbai, Maharashtra, India Double HR Consultancy Full time

    VACANCY REGULATORY AFFAIRS EXECUTIVE (Pharma Company is manufacturing veterinary products) Job Location: Mumbai Maharashtra Eligibility: - M. Sc / B. Sc / M. Pharm / B. Pharm. Degree / Diploma in Regulatory Affairs. - Should have good knowledge of preparing registration of Drugs & Feed Supplements in different countries - Minimum 2 years experience in...

  • Medical Affairs Associate

    1 day ago

    Mumbai, Maharashtra, India Clini launch Business Solutions Full time

    Job Title: Medical Affairs Associate (Fresher) Department: Medical Affairs Location: Mumbai (Andheri West) Job Summary: We are seeking a detail-oriented and scientifically driven Medical Affairs Associate to support our medical affairs team in delivering high-quality, evidence-based support to internal and external stakeholders. This role involves engaging...

  • Regulatory Affairs Executive

    1 week ago

    Mumbai, India Morpheus Human Consulting Full time

    Reference Code: - 319-54 - Job Title: **Regulatory Affairs Executive - Animal Health Care - Mumbai** - Category: - Manufacturing - Job Description: - Our client is one of the leading Manufacturing company of Animal Healthcare Products since 1977. They have around 20 dedicated sales offices in India. - They market wide range of poultry and cattle products....

  • Regulatory Affairs Officer

    7 days ago

    Santacruz West, Mumbai, Maharashtra, India Globofarm International Pvt Ltd Full time

    Job Profile - Regulatory Affairs (FSSAI) Position Regulatory Affairs - FSSAI Compliance Location Santacruz West mumbai Reports To Head - Director Role Purpose To 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...