Regulatory Affairs Executive

2 weeks ago

Shivaji Nagar Pune Maharashtra, India NextUP Pharma Full time

**Job description**

1. Responsible for all medical device registration submission under in India and Indian subcontinent countries as required. Ensure medical devices in the designated geographies obtained approval status before commercialization.
2. Maintain the device registration status and ensure timely re-registration.
3. Provide support the local distributors in India subcontinent countries to register devices when required.
4. Provide guidance and advice in Legal and Regulatory requirements including mandatory label marking requirements.
5. Responsible to review and approve the relevant artwork, package label and marketing materials from regulatory and customs aspects covering inhouse and outsourced product portfolio.
6. Ensures labels for India meet Package Commonality Rules and Customs requirements.
7. Evaluates, reviews and approves product claims on labels and marketing collaterals in accordance to legal and regulatory requirements.
8. Maintains label marking and guidance templates for MED and PPE/ SU products.
9. Provides professional advice, propose feasible solutions and supports local cross
- functional teams in business decision making process.
10. Identify strategy for change management to product and business. Establish plan to ensure effective implementation. Consults the respective governmental agencies on regulatory requirements for new products and major changes in existing products.

**Salary**: ₹12,838.63 - ₹45,075.42 per month

**Benefits**:

- Internet reimbursement

Schedule:

- Day shift

Supplemental pay types:

- Performance bonus

Ability to commute/relocate:

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

**Education**:

- Bachelor's (preferred)

**Experience**:

- total work: 1 year (preferred)

**Speak with the employer**

+91 9762972000

  • Regulatory Affairs Executive

    4 days ago

    Balaji Nagar, Pune, Maharashtra, India Vertex Business Solutions Full time

    Regulatory Affairs Executive act as a link between companies and regulatory authorities, ensuring that products are manufactured, tested and distributed in compliance with appropriate legislation. **Responsibilities**: - studying scientific and legal documents to check they meet legal requirements. - Gathering, evaluating, organising, managing and...

  • Regulatory Affairs Executive

    5 hours ago

    Masjid, Mumbai, Maharashtra, India Amico Formulations LLP Full time

    **Post**: RA Executive **Experience**: 5+ Years Experience in Regulatory Affairs in Pharma Industry (Formulation) **Location**: Masjid Bunder, Mumbai - Experience in handling regulatory affairs for ROW market mainly Central and Latin American, African & Asian countries for Pharma Formulations. - Preparation, Compilation & Review of Registration documents...

  • Regulatory Affairs Executive

    2 weeks ago

    Mumbai, Maharashtra, India Fusion Market Research Full time

    Regulatory affairs officers ensure that products such as foods, cosmetics, pharmaceuticals and veterinary medicines - and the steps involved in developing, testing and marketing them - meet legislative requirements. **Typical duties include**: - studying scientific and legal documents to check they meet legal requirements. - gathering, evaluating,...

  • Regulatory Affairs Executive/ Veterinary Pharma

    2 weeks 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...

  • Regulatory Affairs

    2 weeks ago

    Wagholi, Pune, Maharashtra, India SYS 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 - collect, collate and evaluate scientific data from a range of sources -...

  • Regulatory Affairs Executive

    1 week ago

    Malad, Mumbai, Maharashtra, India SaffronBizz Solutions LLP Full time

    Greetings, We have an excellent opportunity for Regulatory Affairs officer. Location : Malad Experience :1 + year Role: We are seeking a skilled and licensed Regulatory officer to join our team. The products, managing purchase orders, and ensuring proper follow-up procedures. The officer will play a crucial role in maintaining compliance with...

  • Regulatory Affairs Analyst

    1 week 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 Executive

    5 hours ago

    Kanjurmarg, Mumbai, Maharashtra, India Malu healthcare Full time

    **Key Responsibilities**: - Manage regulatory submissions for Class 1 medical devices in India. - Ensure compliance with Indian medical device regulations (MDR). - Maintain regulatory documentation and support product registration processes. - Liaise with regulatory bodies for approvals and updates. **Qualifications**: - Proven experience in regulatory...

  • Regulatory Affairs Executive

    2 weeks ago

    Goregaon East, Mumbai, Maharashtra, India Meliorate Health Pvt Ltd Full time

    Designation: Executive Regulatory Affairs Qualification: B Pharma / M Pharm Department: Regulatory Affairs Location: Goregaon East, Mumbai Joining CTC: Package around 3.00 lacs to 4.00 lacs per anum Job Responsibilities: 1) Dossier Preparation: Preparation and review of standard dossier, ACTD, CTD, ECTD as per Country specific guideline. 2) Query...

  • Regulatory Affairs Executive- Pharma

    2 weeks ago

    Hadapsar, Pune, Maharashtra, India Gowork placement service Full time

    Looking for Regulatory affairs (officer) Experience - 1-2 yrs,Location - Magarpatta,Pune Qualification - B/.Pharm or M.Pharm Pay: ₹215,412.89 - ₹3,000,000.00 per year Schedule: - Day shift **Experience**: - total work: 2 years (preferred) Work Location: In person