Executive- Regulatory Affairs, Regulatory

7 months ago

Mumbai Maharashtra, India Apotex Research Private Limited Full time

**About Apotex Inc.**

Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.

**Job Summary**:

- Maintenance of documentation/database records pertaining to products, in line with systems, processes and procedures
- Supporting and/or coordinating regulatory affairs projects, as assigned

**Responsibilities**:

- Support in review and compilation of deficiency packages for assigned products of US/Canada market within given timeline & with high quality measured against compiler checklist maintained by team.
- Ensure dossier/documents are of high-quality standard to ensure one cycle review from Regulatory authorities
- Support in review and compilation of supplements/pre-launch variations (e.g. CBE, CBE-30, PAS, sANDS and Level -III) for assigned products
- Maintain records in global regulatory databases and in established trackers (Review checklist for NPD/deficiency response/ pre-launch variation, deficiency tracker, status sheet etc.) and ensure accuracy of information
- In depth (detailed) review of all technical documents required for compilation of New Product Submission (NPD - ANDA/ANDS), Pre-launch variations and query responses before sending it for final review.
- Completion of all the assigned trainings in timely manner.
- Actively work to suggest, develop and obtain own Key Performance Measures (KPMs) in conjunction with Reporting Manager
- Ensure compliance with SOPs and regulatory guidelines published from time to time by respective regulatory agencies
- Act as a back-up for team members and support as and when required
- Review of change control forms and provide accurate assessment for change being assessed (as applicable and assigned)
- Timely communication and follow up with the respective departments for compilation and submission of new product submissions, query responses & pre-launch variation to meet agreed timeline
- Provides regulatory support to stakeholders as & when required
- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
- All other relevant duties as assigned.

**Job Requirements**:

- Education:

- A Post graduate/Graduate in pharmacy.
- Knowledge, Skills and Abilities:
- Experience:
At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

  • Regulatory Affairs Executive(Female)

    7 months 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 Executive

    7 months ago

    Andheri East, Mumbai, Maharashtra, India Career Strategy Solutions Full time

    Seeking Drug Regulatory Affairs for a Company into Pharma Industry **Key Responsibilities**: - Research and stay updated on regulatory requirements and guidelines - Coordinate with cross-functional teams to gather necessary documentation and information for regulatory filings - Review and assess product labeling, packaging, and promotional materials to...

  • Regulatory Affairs Executive

    2 months ago

    Deccan Gymkhana, Pune, Maharashtra, India Zetta Women Full time

    **Job Title**:Pharmaceutical Regulatory Affairs Executive **(Intern)** **Location**: Pune, India **Duration**: 9 months (Advanced Certification) + 3 months (On the Job Internship) **Job Summary**: **Key Responsibilities**: 1. Attend classes on weekends (Saturdays and Sundays) 2. Complete coursework, assignments, and projects 3. Participate in...

  • Regulatory Affairs Executive

    3 weeks ago

    Mumbai, India URRI HR Full time

    **Roles and Responsibilities** **Position :Regulatory Affairs Executive** **Qualification**:Graduation+ PG diploma in Regulatory Affairs**Experience **:0to 2 Years**Location **:Dombivali, Mumbai(Experienced or fresh) will be required for the expansion of the Regulatory department. The expansion of the department is necessary to cater to the requirements...

  • Regulatory Affairs Executive

    5 days 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. They are...

  • Regulatory Affairs Executive

    4 days 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 Executive

    3 months ago

    Pune, 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, organising,...

  • Regulatory Affairs Executive

    8 months 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 Position Type New position Location Marol, Mumbai Job Overview Planning, undertaking, and overseeing regulatory work for local & export related products in Agri and Scientific support Responsibilities and...

  • Executive Regulatory Affairs

    3 weeks ago

    Mumbai, Maharashtra, India Gowork placement service Full time

    We are looking for regulatory affairs executive. **Job Types**: Full-time, Permanent Pay: ₹14,197.55 - ₹44,544.75 per month Schedule: - Day shift Application Question(s): - Do you have experience in handling ROW/ Semi Regulated Market? - Do you know how to use excel sheet, Power point? - What's your education qualification? Bpharma or M.Pharma is...

  • Regulatory Affairs Executive

    1 day ago

    Dongri, Mumbai, Maharashtra, India approach Full time

    Designation: Executive - Regulatory Affairs Location: Sandhurst Road, Mumbai Department: API (Active Pharmaceutical Ingredients) Products Handled: Pharmaceutical API, Veterinary API Job Responsibilities: Regulatory Documentation: Prepare, review, and submit DMFs (Drug Master Files), CEPs, and other regulatory documents for Pharmaceutical and Veterinary...

  • Regulatory Affairs Executive

    6 days ago

    Mumbai, India SourceGrids Consulting LLP Full time

    One of our key client is a leading pharmaceutical company headquartered in Mumbai is conducting interview drive for "Regulatory Affairs Executive" role at Dadar office. Interview date and timing - 2nd August'23 between 2 to 5 PM Job role - Regulatory Affairs Executive Experience - 3+ Years Job location - Dadar East, Mumbai Industry - Pharmaceutical /...

  • Regulatory Affairs Officer

    7 months ago

    Mumbai, Maharashtra, India MEDVARSITY ONLINE LIMITED Full time

    Job Title: Senior Executive - Regulatory Affairs UK/IE/MT Department: Regulatory Affairs Grade Level: P-2 Reports to: Manager / Sr. Manager - Regulatory Affairs Number of Reports: NONE Location: Mumbai **Main purpose of role**: To ensure adequate and prompt life cycle maintenance activities for Marketing Authorization’s (MA) held based on portfolio...

  • Regulatory Affairs Officer

    5 months ago

    Mumbai, Maharashtra, India TheTalentforte.com Full time

    Manufacturer of Bio-Pharmaceuticals, Soft Gel Capsules & Multi-Vitamins **REGULATORY AFFAIRS** Job Location: Borivali West **Experience: Min. 2 years in Pharma Formulations** - Conduct quality assurance activities to ensure compliance with regulatory requirements. - Manage regulatory audits by providing necessary documentation and support. - Maintain...

  • Regulatory Affairs Executive

    7 months ago

    Worli, Mumbai, Maharashtra, India RecruitApt Full time

    Looking for RA Executive having min 2 years of Experience **Salary**: ₹40,000.00 - ₹50,000.00 per month Schedule: - Day shift **Experience**: - Regulatory Affairs: 2 years (required) Work Location: In person **Speak with the employer** +91 8002870884

  • Regulatory Affairs Executive

    2 months ago

    Mumbai, India Ipca Laboratories Limited Full time

    Position : Executive - Regulatory affairs formulation for USA market.Qualification : B.Pharm/M.PharmExperience : 4 - 7 years experience of working in regulated markets like USA/ Europe/Australia with experience of ANDA, USA market preferred.Role:- Preparation of registration dossiers as per the US Regulatory guidelines- Preparation of renewal application as...

  • Regulatory Affairs Officer

    1 month ago

    Mira Road, Mumbai, Maharashtra, India Vimek Bioconcept Pvt LTd Full time

    A regulatory affairs (RA) professional in the in vitro diagnostics (IVD) industry typically has responsibilities that include: - **Developing regulatory strategies**: Creating and implementing global regulatory strategies for IVD products - **Reviewing submissions**: Reviewing and revising submissions to regulatory agencies - **Managing change control**:...

  • Regulatory Affairs Executive

    7 months ago

    Goregaon, Mumbai, Maharashtra, India Fast Track Jobs Full time

    We Requires 2 **Regulatory Affairs Executive** for **Pharma **Company at **Goregaon**: - West **Designation**:Regulatory Affairs Executive** Experience : 1 to 3 Years **Education**:B Pharm / M Pharm **[**Compalsary **] Salary : up to 30K Location**:Goregaon**: - **West** **Responsibilities**: - Preparing and submitting the relevant regulatory...

  • Regulatory Affairs Executive/ Veterinary Pharma

    7 months 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 Associate

    7 months ago

    Mumbai, 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...

  • Regulatory Affairs Executive

    2 hours 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...