Regulatory Affairs Api Role with Rusan Pharma

2 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

  • Executive Assistant to Chairman in Kandivali

    3 days ago

    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...

  • Regulatory Affairs Executive

    2 days ago

    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...

  • Digital Marketing Executive

    17 hours ago

    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...

  • 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,...

  • Officer - Regulatory Affairs

    4 days ago

    Mumbai, India TheTalentforte.com Full time

    **Require**:REGULATORY AFAIRS EXECUTIVE/OFFICER **Experience**:Min.2 years experience in Pharma Formulations Regulatory Affairs. Schedule: - Day shift **Speak with the employer** +91 8097337489

  • Regulatory Affairs Officer

    Found in: Whatjobs IN C2 - 5 days ago

    mumbai, India TheTalentforte.com Full time

    Hello Our Client is a Manufacturer and Exporter of Pharmaceutical Formulations We are looking for : REGULATORY AFFAIRS OFFICER Job Location: Mumbai (Central Line) Salary Range Depending on suitability and experience Candidate Criteria B. Pharma / M. Pharma OR Science Graduate with Diploma in Regulatory Affairs Experience: Min.2 Years in Reg. Affairs OR...

  • Regulatory Affairs Officer

    Found in: Appcast Linkedin IN C2 - 5 days ago

    Mumbai, India TheTalentforte.com Full time

    HelloOur Client is a Manufacturer and Exporter of Pharmaceutical FormulationsWe are looking for :REGULATORY AFFAIRS OFFICERJob Location: Mumbai (Central Line)Salary Range Depending on suitability and experienceCandidate CriteriaB. Pharma / M. Pharma OR Science Graduate with Diploma in Regulatory AffairsExperience: Min.2 Years in Reg. Affairs OR Quality...

  • Regulatory Affairs Officer

    Found in: Talent IN 2A C2 - 5 days ago

    Mumbai, India TheTalentforte.com Full time

    HelloOur Client is a Manufacturer and Exporter of Pharmaceutical FormulationsWe are looking for :REGULATORY AFFAIRS OFFICERJob Location: Mumbai (Central Line)Salary Range Depending on suitability and experienceCandidate CriteriaB. Pharma / M. Pharma OR Science Graduate with Diploma in Regulatory AffairsExperience: Min.2 Years in Reg. Affairs OR Quality...

  • Executive Regulatory Affairs

    17 hours ago

    Andheri, Mumbai, Maharashtra, India Eway IT Solutions Full time

    Provide expert regulatory input to strategic decision making; including portfolio review, prioritization, and external communications, Product packaging, Artwork etc.  Provide expert regulatory input to in-licensing evaluations and due diligence activities  Provide advice about regulations to manufacturers/scientists  Ensure that quality...

  • Regulatory Executive

    Found in: beBee S IN - 7 days ago

    Mumbai, India Double HR Consultancy Full time

    DESCRIPTIONVACANCYREGULATORY AFFAIRS EXECUTIVE(Pharma Company is manufacturing veterinary products)Job Location: Mumbai MaharashtraEligibility : 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 the...

  • Regulatory Executive

    Found in: beBee jobs IN - 6 days ago

    Mumbai, Maharashtra, India Double HR Consultancy Full time

    VACANCYREGULATORY AFFAIRS EXECUTIVE(Pharma Company is manufacturing veterinary products)Job Location: Mumbai MaharashtraEligibility : 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 the same...

  • Regulatory Affairs Specialist

    Found in: Whatjobs IN C2 - 1 week ago

    mumbai, India Tesloye Consultancy Services Full time

    We are looking for a motivated and experienced Regulatory Affairs Specialist to join our team! As a Regulatory Affairs Specialist, you will be responsible for the day-to-day monitoring of the companys regulatory activities to ensure compliance with all regulations. You will be a key member of our regulatory affairs team, which is responsible for the companys...

  • Regulatory Affairs Specialist

    Found in: Talent IN C2 - 2 weeks ago

    Mumbai Suburban, India Tesloye Consultancy Services Full time

    We are looking for a motivated and experienced Regulatory Affairs Specialist to join our team! As a Regulatory Affairs Specialist, you will be responsible for the day-to-day monitoring of the companys regulatory activities to ensure compliance with all regulations. You will be a key member of our regulatory affairs team, which is responsible for the companys...

  • Regulatory Affairs Executive

    6 days ago

    Sion, Mumbai, Maharashtra, India Automobile dealership Full time

    Please find JD for Regulatory Affairs: 1. Preparation of Dossier in CTD, ACTD and country specific format. 2. Resolving queries received from various Ministry of Health. 3. Preparation of Technical master file for Medical Device. 4. Finalization of Artwork as per Country specific guidelines. 5. Co-ordination with vendors for DMF and API related data. 6....

  • Sr. Manager

    Found in: Whatjobs IN C2 - 2 weeks ago

    mumbai, India KlinEra Global Services Full time

    The Sr. Manager, Regulatory Affairs will be responsible for overseeing regulatory activities related to clinical trials conducted by the clinical research organization. This position will play a crucial role in ensuring compliance with regulatory requirements and providing strategic regulatory guidance to internal teams and clients. The Sr. Manager,...

  • Sr. Manager

    Found in: Whatjobs IN C2 - 2 weeks ago

    Mumbai, India KlinEra Global Services Full time

    The Sr. Manager, Regulatory Affairs will be responsible for overseeing regulatory activities related to clinical trials conducted by the clinical research organization. This position will play a crucial role in ensuring compliance with regulatory requirements and providing strategic regulatory guidance to internal teams and clients. The Sr. Manager,...

  • Sr. Manager

    Found in: Appcast Linkedin IN C2 - 3 weeks ago

    Mumbai, India KlinEra Global Services Full time

    The Sr. Manager, Regulatory Affairs will be responsible for overseeing regulatory activities related to clinical trials conducted by the clinical research organization. This position will play a crucial role in ensuring compliance with regulatory requirements and providing strategic regulatory guidance to internal teams and clients. The Sr. Manager,...

  • Sr. Manager

    Found in: Talent IN 2A C2 - 2 weeks ago

    Mumbai, India KlinEra Global Services Full time

    The Sr. Manager, Regulatory Affairs will be responsible for overseeing regulatory activities related to clinical trials conducted by the clinical research organization. This position will play a crucial role in ensuring compliance with regulatory requirements and providing strategic regulatory guidance to internal teams and clients. The Sr. Manager,...

  • Manager Regulatory Affairs

    Found in: beBee jobs IN - 3 weeks ago

    Mumbai, Maharashtra, India Abbott Laboratories Full time

    MAIN PURPOSE OF ROLE Specialist professional individual contributor with comprehensive knowledge in the area of Regulatory Affairs. Ability to execute highly complex or specialized projects. Adapts precedent and may make significant departures from traditional approaches to develop solutions. MAIN RESPONSIBILITIES As the Specialist in the Regulatory Affairs...

  • Executive Regulatory Affairs

    17 hours ago

    Mumbai, India Ample Leap Cognition & Technologies Pvt Ltd Full time

    **Job Description Form** **Fields** **Required Information** **Job Title** **Executive - Agriculture Regulatory Affairs** Reports To Manager CTC Budget 3-4 LPA Position Type New position Location Marol, Mumbai Job Overview Planning, undertaking, and overseeing regulatory work for local & export related products in Agri and Scientific...