Regulatory Affairs Api Role with Rusan Pharma

3 weeks ago


Mumbai, India Rusan Pharma Full time

We have Excellent Job Opportunity for Regulatory Affairs Role (API), Kandivali.

**KRA:
- **To ensure the preparation, review and filing of annual reports, supplements, variations and periodic reports, for all approved products**
- **Timely Response of DMF deficiencies.**

**Job Responsibility:
- Planning, execution, review and submission of Drug Master File (DMF) for Regulated ,Semi Regulated & other geographical markets in CTD/eCTD format.
- Cross-functional meeting & satisfactorily addressing the deficiencies conveyed by the regulatory agencies with adequate data and within stipulated timeline.
- Compilation, review and submission of DMF amendments
- Interaction with cross functional team members of R&D, Marketing, QC, QA, Production and Purchase department on various commercial/technical issues, documentation as required for responding to queries etc.
- Provide notifications to clients for the prior-approval and annual changes. Arrange acceptance from client, schedule submissions to meet assigned goal by organization.
- Consolidate the submission plan in coordination with the business teams and ensure global regulatory filings as per the business plan.
- Review the Drug Master Files prepared by Plant Regulatory teams to ensure the submission requirements in respective countries/customer.
- Provide the inputs to the team for defining the regulatory strategy for post-approval changes with respect to specifications and methods, manufacturing process, alternate manufacturing sites, rationalized products to ensure timely support for their approvals and keep the customer updated on active and Inactive dmfs.
- Maintain and update the tracker for shared dmfs to customers, deficiency response to agencies, issued loas, shared change proposals.

**SKILLS & ABILITIES:
- M.Sc. / M. Pharmacy with 5 + years of work experience
- Hands on experience of API DMF preparation
- **Current guideline requirement awareness**:

- Advance Verbal and Written communication skills.
- Complete understanding of API global regulatory affairs
- Should have knowledge in Analytical, Quality, cGMP, Manufacturing & IP
- **Strong understanding of API development, manufacturing processes, and quality control systems.**:

- ** Detail-oriented with a high degree of accuracy and ability to work under pressure.**:

- ** Ability to multitask and prioritize tasks effectively.**

If you are not interested but know someone who might be interested, we would welcome the recommendations
- Role:
Regulatory Affairs Compliance
- Salary:
6-7 Lacs P.A.
- Industry:
Pharmaceutical & Life Sciences
- Department:
Legal & Regulatory
- Role Category:
Corporate Affairs
- Employment Type:
Full Time, Permanent
- Key Skills

Regulatory Affairs API

API global regulatory affairs

API DMF preparation

regulatory affairs

Skills highlighted with ‘‘ are preferred keyskills
- Education
- PG:
MS/M.Sc(Science) in Any Specialization

Company Profile
- Rusan Pharma
- Rusan is a research driven pharmaceutical company having its Manufacturing Units in India and Worldwide Marketing of Pharmaceutical Formulation, Active Pharmaceutical Ingredients and Intermediates. The company has its own Research & Development centre at Kandivli (west), Mumbai, state of the art, Bulk Manufacturing Plant at Ankleshwar and Formulation plant at Dehradun and SEZ, Kandla having approval of MHRA (UK), MCC (SA) and other International Health Authorities. March 2008 - 82 Crs., Expected by March 2009 €“ 150 Crs.

Contact Company:
Rusan Pharma

Address:
58-D,GOVT INDUSTRIAL ESTATE, MUMBAI, Maharashtra, India



  • Mumbai, India Rusan Pharma Full time

    **Location : Kandivali WEST** **Roles and Responsibilities**(API) - Market : ROW- Education /Qualification : M.Sc. /B. Pharm/M. Pharm - Experience : 2 to 6 years - Job Profile: - DMF filing in regulatory / non regulatory market. - Co-ordination with site for all the data required for initial filing and queries received. - To review the documents...


  • Mumbai, India Rusan Pharma Full time

    **Greetings!** **Industry**:Pharma (Formulations) **Market**:Export / International ( ANZ, Canada ,Latam, Europe, SEA, CIS, MENA) **Experience**:18 + **CTC**:25 LPA **Job Responsibility**: - Develop the vision and strategy for expanding business in LATAM, Europe, MENA, SEA, CIS. - Maintain all company distributors for all assign territories and perform...


  • Mumbai, India Rusan Pharma Full time

    Greetings ! Let me take this opportunity to introduce our company to you. Rusan is a fully integrated global pharmaceutical Company specialized in the treatment of addiction (drugs, alcohol, smoking) and Pain Management. It is indeed true that the performance of any company is a reflection of the people working within the company. Rusan Management...


  • Mumbai, India Rusan Pharma Full time

    **LOOKING FOR CANDIDATE WITH 3 TO 6 YRS OF EXPERIENCE IN PACKAGING AND DEVELOPMENT AT OUR CORPORATE OFFICE BASED IN KANDIVALI (W), MUMBAI.** **Roles and Responsibilities** - Finalizing dimension for primary, secondary and tertiary packaging material. - Overall responsibility of Existing and New product Artwork Designing (Cartons, Foil, Tubes, Pouch, Label,...


  • Charkop, Mumbai, Maharashtra, India Rusan Pharma Full time

    Greetings, Let me take this opportunity to introduce our company to you. Rusan is a fully integrated global pharmaceutical Company specialized in the treatment of addiction (drugs, alcohol, smoking) and Pain Management. It is indeed true that the performance of any company is a reflection of the people working within the company. Rusan Management...


  • Mumbai, India Rusan Pharma Full time

    **Greetings from Rusan Pharma Rusan Pharma Ltd. is a fully integrated global pharmaceutical company specializing in the treatment of 'Addiction and Pain Management'. Since 1994, we have been diligently working towards making Opioid Substitution Treatment (OST), a widely accepted form of treatment in India. Towards achieving this objective, we work with all...

  • Sales Admin

    4 weeks ago


    Mumbai, India Rusan Pharma Full time

    **Job Responsibility: - SFA-Analysis and Reports to Management SFA-Addition/Deletion/Follow-up - SAP / SanEforce updating of Basic Data - SPR/Sample Accounting Control - Assisting Head HR/ Field HR / BU Head with his follow-ups - Full & Final settlement follow-up and papers - Field due/review/overdue of Appraisals. - Training programs letters & follow up -...


  • Mumbai, India Omnicals Pharma Limited Full time

    Company DescriptionOmnicals Pharma Pvt Ltd is a Mumbai-based company specializing in Global Pharma Business Development. We work with prestigious clients who are approved by regulatory bodies, with presence in more than 50 countries, we are expanding further and looking for extensive RA team to Hire.Role DescriptionThis is a full-time on-site role for a...

  • Digital Marketer

    4 weeks ago


    Mumbai, India Rusan Pharma Full time

    **Job brief**: - We are looking for an experienced Digital Marketing Executive/Sr. Executive to assist in the planning, execution and optimization of our online marketing efforts for Navicare clinic - Experience in the field of healthcare industry will be an added advantage. - He/She should be will be well versed in the concepts surrounding digital...


  • Charkop, Mumbai, Maharashtra, India Rusan Pharma Full time

    **We are looking Executive Tender / Institutional Business in our Kandivali HO.** **Qualification : B.Sc/ B.Pharma / Any Graduate.** - Track relevant tenders through various sources such as online search engines, industry and market intelligence data etc., which are needed for submission - Fill tenders accurately and timely and submit on time - Knowledge of...


  • Mumbai, Maharashtra, India SUN PHARMA Full time

    We are seeking a Global Regulatory Affairs Manager to lead our regulatory operations team at SUN PHARMA. The successful candidate will have extensive experience in regulatory affairs submissions, particularly in CTA and CTIS. They will be responsible for managing regulatory operations activities, including CTA applications, CTIS management, submission...


  • Mumbai, India HRD House Full time

    From 3 to 5 year(s) of experience- ₹ 4,00,000 - 6,00,000 P.A.- Mumbai Suburban**Job description** You will be based at a R&D center of API / Bulk Drugs in Mumbai - Western Suburbs. - Key Skills Regulatory AffairsAPI research developmentbulk drugsdmfRA Skills highlighted with ‘‘ are preferred keyskillsEducation - UG:_B.Pharma in Any Specialization -...


  • Mumbai, India Rusan Pharma Full time

    **Roles and Responsibilities** **Job brief**: We are looking for an experienced Digital Marketing Executive/Sr. Executive to assist in the planning, execution and optimization of our online marketing efforts for Navicare clinic Experience in the field of healthcare industry will be an added advantage. He/She should be will be well versed in the concepts...


  • Mumbai, India Archerchem healthcare pvt ltd Full time

    **We are Urgently looking for Regulatory Affairs - API** **Company name - Archerchem Healthcare Pvt Ltd** **Responsible for all regulatory affairs for API regulatory filings** **DMF compiling and filings** **Online filing of DMF as required.** **Customer queries to respond and resolve** **CEP filings to be done** **Education** **UG: B.Sc in...


  • Mumbai, India Astellas Pharma Full time

    Astellas Pharma India i s looking for a Regulatory Affairs (RA) Manager , based in Mumbai, India. Purpose and Scope: Planning, preparation and submission for Market Authorization, Registration of product, new indication, and maintenance of registration and its compliances. Interaction and coordination with DCGI(CDSCO) and SFDA and concerned regulatory bodies...


  • Mumbai, India Double HR Consultancy Full time

    Mumbai, Andheri 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...


  • Mumbai, Maharashtra, India SUN PHARMA Full time

    Responsibilities and RequirementsThis role is responsible for managing regulatory operations activities, including CTA applications, CTIS management, submission management, and eCTD publishing. The ideal candidate will have a strong understanding of global regulatory filing requirements and eCTD/CTIS structure.Key ResponsibilitiesDevelop and implement...


  • Mumbai, Maharashtra, India SUN PHARMA Full time

    Key ResponsibilitiesThe GMP Regulatory Affairs Professional will be responsible for ensuring the presence and participation during manufacturing for process validation batches, reviewing quality system documents, and facilitating cause-based or routine visits to CMO sites.Additionally, this role involves reviewing batch manufacturing and packaging records,...


  • Mumbai, India Astellas Pharma Full time

    Astellas Pharma India i s looking for a Regulatory Affairs (RA) Manager , based in Mumbai, India.Purpose and Scope:Planning, preparation and submission for Market Authorization, Registration of product, new indication, and maintenance of registration and its compliances.Interaction and coordination with DCGI(CDSCO) and SFDA and concerned regulatory bodies...


  • Mumbai, India Astellas Pharma Full time

    Astellas Pharma India is looking for a Regulatory Affairs (RA) Manager, based in Mumbai, India.Purpose and Scope:- Planning, preparation and submission for Market Authorization, Registration of product, new indication, and maintenance of registration and its compliances.- Interaction and coordination with DCGI(CDSCO) and SFDA and concerned regulatory bodies...