Am - Drug & Regulatory Affairs (Pharmaceutical

1 week ago


Chandigarh, India Maya Biotech PVT LTD Full time

Dossier preparation, compilation and review.
- Preparing of STS,STP,COA,STABILITY DATA.
- Knowledge of CTD & ACTD Studying scientific and legal documents
- gathering, evaluating, organising, managing and collating information in a variety of formats
- ensuring compliance with regulations set by the Medicines and Healthcare products Regulatory Agency (MHRA)
- maintaining familiarity with company product ranges
- planning, undertaking and overseeing product trials and regulatory inspections
- keeping up to date with changes in regulatory legislation and guidelines
- analysing complicated information, including trial data
- offering advice about company policies, practices and systems
- providing advice about regulations to manufacturers/scientists
- ensuring that quality standards are met and submissions meet strict deadlines
- preparing documentation.
- 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
- collate and evaluate scientific data from a range of sources
- develop and write clear explanations for new product licences and licence renewals
- undertake and manage regulatory inspections
- review company practices and provide advice on changes to systems
- liaise with, and make presentations to, regulatory authorities
- undertake and manage regulatory inspections

Schedule:

- Day shift
- Morning shift

Ability to commute/relocate:

- Industrial Area, Chandigarh - 160002, Chandigarh: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 9 years (preferred)
- Drug & regulatory affairs: 5 years (preferred)

**Speak with the employer**

+91-XXXXXXXXXX


  • Regulatory Affairs

    3 days ago


    Chandigarh, India VEE AAR PLACERS ( P ) LTD. Full time

    **Opening for Regulatory Affairs (RA) Pharma API Plant near Chandigarh.** **We are having following positions in RA -** **Head - RA** **Executive / AM - RA** - **Please e mail your updated profile mentioning present CTC**_ **VEE AAR PLACERS PVT.LTD.** - **MANAGEMENT CONSULTANTS **_ - **CHANDIGARH,**_ - **9056260260,8054276779**_ **Salary**:...


  • Chandigarh, Chandigarh, India Sysmed Medical Technologies Full time

    **Documentation Executive for Regulatory Compliance** 1) Ensure compliance with regulatory requirements for product registration, renewals, and variations. 2) Prepare and review technical documents, including stability data, product formulation, and analytical reports. 3) Liaise with internal departments such as R&D, Quality Assurance, Quality Control,...

  • Dra -executive

    1 week ago


    Chandigarh, Chandigarh, India Maya Biotech PVT LTD Full time

    **Job Summary**: The DRA Executive will be responsible for supporting regulatory submissions, compliance, and approvals for pharmaceutical products specifically for **injectable pharmaceutical products**, ensuring alignment with global and local regulatory requirements. The role involves coordination with cross-functional teams to ensure timely regulatory...


  • Chandigarh, India Aishwarya Healthcare Full time

    **JOB RESPONSIBILITIES FOR DRA OFFICER** 1. Dossier writing, compilation and evaluation of dossiers as per the guidelines of various countries in CTD/ACTD and Regional format. 2. Responsible for dossier preparation/compilation & submission of assigned dossiers and maintaining data base. 3. Handling queries received by MOH/Consultant and respond the...


  • Chandigarh, India Mcbrex Lifesciences Full time

    __ We are seeking a highly motivated and dynamic individual to join our team as a Pharmaceutical Sales Representative. In this role, you will be responsible for promoting and selling our pharmaceutical products to healthcare professionals within your assigned territory. - **Responsibilities**:_ - Build and maintain strong relationships with healthcare...


  • Chandigarh, India EDEN CRITICAL CARE HOSPITAL Full time

    Qualification - DPharm, BPharm As a hospital pharmacist he/she will be responsible for providing pharmaceutical care to patients within a hospital setting. Their primary role is to ensure safe and effective medication use, working collaboratively with other healthcare providers to optimize patient outcomes. Here's a comprehensive overview of a hospital...


  • Chandigarh, Chandigarh, India Daksh Pharma Pvt. Ltd. Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Company DescriptionMsea Pharmaceuticals is located in Ponta Sahib ( manufacturing unit under the Daksh Group). We are committed to providing high-quality medicines to individuals worldwide, with a focus on making healthcare accessible and affordable. Our diverse portfolio of medicines covers various therapeutic areas. We prioritize quality and adhere to...

  • Marketing Executive

    5 days ago


    Sector B chandigarh, Chandigarh, India Herrick Healthcare Full time ₹ 4,00,000 - ₹ 12,00,000 per year

    Key Responsibilities:Assist in developing and implementing marketing strategies for pharmaceutical products Coordinate with the medical and sales teams to align marketing activities with product positioning Conduct market analysis to identify trends, competitor strategies, and customer needs Support the launch of new products and promotional...


  • Chandigarh, Chandigarh, India Dr Krishna's Cancer Healer Center Pvt Ltd Full time

    The Pharmacist will be responsible for dispensing medications, advising patients on proper medication use, and ensuring compliance with regulatory requirements. This role involves collaborating with healthcare professionals, maintaining accurate records, and providing excellent customer service. Key Responsibilities: - Medication Dispensing: Precisely...

  • Pharmacist

    1 day ago


    Chandigarh, India Acme Hr Consulting Full time

    Pharmacist related to sales and handling medical chemist shop Licences is must Experience: 1-4 years ** *Knowledge of generic medicines or substitutes is must* We are looking for a qualified pharmacist to assist customers by interpreting symptoms and providing immediate treatment or to successfully refer customers to a suitable physician. You will also...