Regulatory Affairs Manager

3 weeks ago


Nellore, Andhra Pradesh, India Rubicon Research Limited Full time

About Us

Rubicon Research Limited is a fast-growing pharmaceutical formulations company delivering value to our customers and investors by developing, manufacturing, and marketing branded specialty and generic prescription pharmaceutical products in regulated markets.

We have an established marketing, sales, and distribution platform in the US through our subsidiaries AdvaGen Pharma that markets non-branded prescription products and Validus Pharmaceuticals that markets branded prescription products and promotes them to healthcare practitioners in the US.

We have two US FDA inspected R&D facilities – one each in India and Canada, and two manufacturing facilities in Maharashtra, India with multiple accreditations from multiple regulatory agencies such as US FDA, Food and Drugs Administration, Maharashtra (WHO-GMP accreditation) and Health Canada. Our facilities are equipped with a range of drug development and manufacturing capabilities across dosage forms.

Headquartered in Thane, India we have a sales and marketing office in New Jersey, USA.

Job Title: Regulatory Affairs Manager

Type: Full-time

Location: Thane, Maharashtra

Job Overview:

The successful candidate will manage product registrations in key regulated markets of Canada and Australia, including preparing dossiers, submitting applications for product registrations, addressing query responses to obtain product approvals, and meeting any annual requirements. They will also liaise with cross-functional teams and manufacturing plants to obtain necessary documents for product filings, interact with regulatory bodies on administrative and technical matters, and manage a team of professionals to deliver planned filings and approvals.

Key Responsibilities:

  • Managing product registrations in key regulated markets of Canada and Australia, including dossier preparation, submission, query response, and registration.
  • Submitting post-approval variations and meeting annual requirements in these markets.
  • Liaising with cross-functional teams and manufacturing plants to obtain necessary documents for product filings.
  • Interacting with regulatory bodies on administrative and technical matters.
  • Managing a team of professionals to deliver planned filings and approvals.

Requirements:

  • Minimum 10-15 years of experience in regulatory affairs, preferably in CA and AU markets.
  • Proven experience in dossier preparation, submission, query response, and registration in key regulated countries.
  • M.Pharm or M.Sc degree required.
  • Excellent communication and planning skills.

Salary Estimate:

$120,000 - $180,000 per annum, depending on experience and qualifications.


  • Junior Consultant

    3 weeks ago


    Nellore, India eGovern Full time

    eGovern is seeking a Junior Consultant to join our team to support Global South governments build meaningful friendships with governments and multilateral organisations. This is a unique opportunity to be part of a team that is redefining diplomacy—using innovative approaches to forge international partnerships, drive economic cooperation, and move the...

  • Deputy Manager

    1 week ago


    Nellore, India Canara HSBC Life Insurance Full time

    The role involves dealing in Fixed Income Securities (G-Ssec, SDL, Corporate Bonds, CD, CP etc.) and timely settlement of the same within IRDA guidelines. The focus should be on efficient execution of trades in the market. The role also involves closely working with Mid and Back office for timely settlement of all deals. The role involves providing support...

  • Reinsurance Manager

    1 month ago


    Nellore, India Kshema General Insurance Limited Full time

    About the Company - Kshema General Insurance Limited (Kshema) was established in 2018 and is India's only Digital Agri Insurance Company catering to farmers/cultivators in the Agriculture Sectors. Kshema enables cultivators with resilience from financial distress due to extreme climate events and perils through localised insurance products. Kshema is...


  • Nellore, India SIRO Clinpharm Pvt. Ltd. Full time

    Advanced degree in a relevant scientific/clinical/regulatory field preferred; Bachelor’s degree is required.At least 7 years of experience writing clinical/regulatory documents for a pharmaceutical or biotechnology company is required.Experience as lead writer for key documents included in major US and/or international regulatory submissions...


  • Nellore, India Charles Group Full time

    Charles Group is a fastest growing organization in India, We are seeking a seasoned Assistant Manager - Legal to join our dynamic team and oversee our legal operations.Education:Bachelor’s degree in Law (LLB or equivalent) from an accredited institution.Additional certifications or a master’s degree in law (LLM) or corporate law is a plus.Experience:3-5...


  • Nellore, India SMA - Strategic Management Alliance Full time

    Job Title: General Manager, Airside OperationsLocation: Andhra PradeshSalary Band : 38 - 42LPA Company: Client of Strategic Management AllianceAbout the Company:Our client is one of India's leading Services & Infrastructure Conglomerates with interests in Infrastructure, Retail, Airport Development, Services Business etc.Position Summary:Overall responsible...


  • nellore, India Dhruva Space Full time

    Role overview and responsibilities Dhruva Space is seeking a passionate Geospatial Business Analyst-Intern to work closely with regulatory bodies, clients, and technical teams in developing satellite imagery-based solutions. This hands-on role provides a unique opportunity to explore the intersection of remote sensing technology, business development, and...

  • Design Engineer

    1 week ago


    Nellore, India Tata Projects Full time

    Role holder expected to have good knowledge of design of substation from 66kV to 765 kV AIS and GIS, responsible for all activities related to substation engineering like preparation and review of engineering documents for substation. Qualification: BE. or B. Tech. in Electrical / Civil Engineering from reputed universityExperience: 5-15 Years in substation...

  • Quality Controller

    3 months ago


    Nellore, India NAVCO INDUSTRIES PVT LTD Full time

    Reports to - Factory Manager Profile Overview: The QC officer achieves quality assurance operational objectives by contributing information, assure to maintain QMS ISO 13485 by preparing and completing action plans. Validates quality processes by establishing product specifications and quality attributes, writing and updating quality assurance...


  • Nellore, India Twinhatch Legal Services Full time

    Intern - Legal and ComplianceCompany: Twinhatch Pvt. Limited (Twinhatch Legal Services)Location:RemoteDuration:1 ( On e) monthStipend: UnpaidEligibility: Freshers, final year law students, and pursuing CS are welcome to apply.Job Summary:We are seeking a highly motivated and detail-oriented intern to assist our legal and compliance team at Twinhatch Legal...


  • Nellore, India ACL Digital Full time

    Work Mode: Office Shift Mode : EST Time Zone Location: Bengaluru Primary Job Duties:Manage all US immigration cases (H-1B, L-1A/B, TN, E visa, and Green Card) and assess potentialavailable options and sponsorship viability by working closely with employees, HR, and recruitingmanagers.Independently manage day-to-day aspects of high-volume caseload and...


  • nellore, India Biocon Full time

    Job Description As a Regional lead you will lead the commercial efforts across the region in India to maximize the market opportunities. Your primary management responsibility will be managing business operations, including maximizing sales and market share gain for products and/or services throughout assigned regions in India domestic and regulated market....


  • Nellore, India Peoplemint Consultants Full time

    Experience:-15+ YearsGrade:- EVPBudget:- Open for discussionLocation:- KolkataJob details:-The Head-Credit Administration & Bank Control Unit role will lead the two verticals in the Bank. Currently, the Bank does not have a dedicated Credit Administration Vertical. The incumbent will be responsible for setting up the entire vertical in line with the...

  • Food Safety Officer

    2 weeks ago


    Nellore, India Parul University Full time

    Job Title: Food Safety OfficerOrganization: Parul University, Vadodara, GujaratAccreditation: NAAC A++Role Summary:Parul University seeks a qualified Food Safety Officer to oversee food safety measures, conduct inspections, ensure compliance with standards, and train staff on proper food handling across its food courts and mess...


  • Nellore, India LATS Solutions Private Limited Full time

    **Qualification**: - 12th or Above **Mandatory Documents: Minimum Eligibility Criteria** - Pan Card - Aadhar Card - **Permanent/Learner Driving License**: - Bikes and Smartphones having Android OS Version 10 - Passport Size Photo/Selfie - Bank Details - Passbook or Cancel Cheque or Statement Job Overview: The Outlet Verification Associate will be...

  • Head of Department

    1 week ago


    Nellore, India CHANDIGARH UNIVERSITY Full time

    Job Title - HOD Department - Interior Design DepartmentLocation - Chandigarh University Experience - 10 + Years Qualification - Masters in Design / Bachelors in Design JOB SUMMARY:Provide effective leadership to Interior Design teaching, research and extension.Essential Duties and Responsibilities: Formulate and implement Interior design department...

  • Infrastructure Analyst

    2 months ago


    Nellore, India DuPont Full time

    At DuPont, we are working on things that matter, whether it’s providing clean water to more than a billion people on the planet, producing materials that are essential in everyday technology devices from smartphones to electric vehicles, or protecting workers around the world.If you would like to be a part of a premier multi-industrial company that is...


  • Nellore, India GE HealthCare Full time

    As a Staff Software Engineer You will be responsible for the design and development of Linux based embedded software for diagnostic cardiology (DCAR) products. You will work independently and contribute to the immediate team and to other teams across business. You will Lead design discussions.GE HealthCare is a leading global medical technology and digital...

  • Fraud Analyst

    3 weeks ago


    Nellore, India Genpact Full time

    Job Description :Minimum qualificationsVoice Process• Candidate should have at least 1-3 years’ experience performing Banking/Dispute Investigations in the debit and/or credit card industry• Keen attention to detail & risk identification• Basic knowledge of Banking Industry & Regulatory Environment with in-depth knowledge of Regulations E, Z, CFPB,...

  • Security Analyst

    4 weeks ago


    Nellore, India NEXUS CONSULTING SOLUTIONS Full time

    Full Job Description -Resource will work as an Information Security Analyst responsible for auditing and monitoring systems containing confidential information. This position is also responsible for helping the organization manage its risks by monitoring the organization’s IT systems for inefficiencies, inaccuracies, mismanagement, etc. Tasks will include...