Regulatory Operations Expert

7 days ago

Mumbai, Maharashtra, India Fortrea Full time ₹ 12,00,000 - ₹ 24,00,000 per year
Job Overview:Perform various project management and regulatory affairs activities for Fortrea clients.Manage team including performance reviews, human resource issues, and assist Senior Management in assigning resources to projects as required.Manage, coordinate and oversee the overall Regulatory Operations associated with creation/revision/compilation/approval of specifications, regulatory and labeling documents across the product lifecycle for submission by Fortrea clients to US, EU, Japan, and ROW health authorities within the agreed/stated timelines, as applicable. The post holder is responsible for supporting team members in providing this service to clients either as a support function to the client project groups or as stand-alone business.Provide all clients, both internal and external, with the appropriate quality of service in a safe and cost-effective manner.Summary of Responsibilities:
  • The contractor will report into the team lead of the QA Laboratory group of CSQ of the global Product Quality Management (PQM) organization located In Beerse Belgium.The contractor will work from the JnJ premises: Mumbai, Maharashtra, IndiaThe team is responsible for quality oversight and quality assurance support for the JnJ laboratories, and their contract laboratories used by TDS.
  • Review and approval of documents such as but not limited to protocols and report for Method qualification, method validation, transfer; methods; investigations.
  • Handling of Quality Issues, Corrective/Preventive Actions, and Change Controls related to the SMPD laboratories as well as their contract laboratories
  • Works with the supported departments to maintain and continuously improve the quality culture to positively influence Quality KPI.
  • Actively participates to meetings with business such as Capa board, Quality improvement program and team e.g. connect meetings
Qualifications (Minimum Required):
  • Bachelor or Master degree, scientific oriented (pharmaceutical, chemical or biological sciences) or equivalent by experience
  • 3-5 years' experience in pharmaceutical industry
  • Experience and affinity with the laboratory environment (method development method validation, release & stability testing, micro,…), quality assurance, pharmaceutical development, instrument qualification, IT, automation
  • ability to work across organizational boundaries, cultures
  • influencing, negotiation and partnering in a global environment
  • Positively react to changes and show agile behavior
  • In-depth knowledge of cGMP and ICH guidelines
  • Excellent verbal and written communication skills (English)
  • Demonstrates Diversity & Inclusion behavior
  • Team player
Physical Demands/Work Environment:
  • Physical demands: Available for regional or global travel 5-10% of the time including overnight stays as necessary consistent with project needs and office location.
  • Work environment: Office environment or remote.

Learn more about our EEO & Accommodations request here.

  • Maritime Regulatory Manager

    7 days ago

    Mumbai, Maharashtra, India Comaea Consulting Full time ₹ 80,000 - ₹ 1,20,000 per year

    Our client is a MNC n the maritime industry. To support the growth strategy and its expansion, our client is seeking an experiencedMaritime Regulatory Manager.Fleet Compliance Manager(Based in London/Greece)ORGANISATION:We are hiring on behalf of a leading global shipowner and shipping solutions provider, with a strong presence across Asia and Europe. The...

  • Regulatory Mammalian Toxicology

    3 days ago

    Navi Mumbai, Maharashtra, India UPL Limited Full time ₹ 1,20,000 - ₹ 1,80,000 per year

    JOB SUMMARY:Knowledgeable in all disciplines of ecotoxicology, including aquatic, plants, avian, mammals, and terrestrial.Conduct ecotoxicological risk assessments and provide expert guidance to internal colleagues on ecotoxicology issues, including responses to Regulatory decisions, Data Call In reviews and recommendations, and planningdefense strategies...

  • Global Regulatory Operations Senior Executive

    2 weeks ago

    Navi Mumbai, Maharashtra, India UPL Ltd Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Global Regulatory Operations Senior Executive - APACJob Id: 11870City:Navi Mumbai, Maharashtra, IndiaDepartment: RegulatoryFunction: Regulatory Science & Government AffairsEmployee Type: Permanent Full TimeSeniority Level: ExecutiveDescription:ob Summary:The Regulatory Operations Specialist will be responsible for managing and executing regulatory...

  • Regulatory Reporting, AS

    2 weeks ago

    Mumbai, Maharashtra, India Deutsche Bank Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    Job Title: Regulatory Reporting, ASLocation: Mumbai, IndiaRole DescriptionIt is a regulatory reporting role. The candidate is expected to prepare / check the various regulatory reports to be filed with Central Bank, SEBI, Income Tax, FIU, etc. on timely manner.Further, candidate is expected to provide various adhoc requirements sought by the regulators on...

  • Global Regulatory Operations Senior Executive

    2 weeks ago

    Navi Mumbai, Maharashtra, India upllimited Full time ₹ 15,00,000 - ₹ 25,00,000 per year

    ob Summary:The Regulatory Operations Specialist will be responsible for managing and executing regulatory strategies, submissions, and compliance activities across the Asia-Pacific (APAC) region. This role ensures that products meet all regulatory requirements for market access, lifecycle management, and post-market surveillance. The position involves...

  • Regulatory Operations Specialist II

    1 week ago

    Mumbai, Maharashtra, India Fortrea Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Job Overview:Responsible to provide analytical support for the developmental projects/comparative dissolution projects received from other client sites.Summary of Responsibilities:These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties as individual...

  • Regulatory Operations Specialist II

    6 days ago

    Navi Mumbai, Maharashtra, India Fortrea Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    Job Overview:Responsible to provide analytical support for the developmental projects/comparative dissolution projects received from other client sites.Summary of Responsibilities:These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills, and duties as individual...

  • Regulatory Reporting Specialist

    2 weeks ago

    Mumbai, Maharashtra, India JPMorgan Chase Full time

    Join our dynamic Regulatory Controls Team and shape the future of regulatory trade reporting. Be at the forefront of innovation, collaborating with Change Management and key stakeholders. Make a meaningful impact by exceeding regulatory requirements in a fast-paced, global environment.Job SummaryAs a Regulatory Reporting Analyst within the Regulatory...

  • Network Engineer

    1 week ago

    Mumbai, Maharashtra, India Ares Operations Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Over the last 20 years, Ares' success has been driven by our people and our culture. Today, our team is guided by our core values – Collaborative, Responsible, Entrepreneurial, Self-Aware, Trustworthy – and our purpose to be a catalyst for shared prosperity and a better future. Through our recruitment, career development and employee-focused programming,...

  • Specialist, Cybersecurity Regulatory

    2 weeks ago

    Mumbai, Maharashtra, India DBS Bank Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Business FunctionTechnology and Operations (T&O) enables and empowers the bank with an efficient, nimble and resilient infrastructure through a strategic focus on productivity, quality & control, technology, people capability and innovation. In Group T&O, we manage the majority of the Bank's operational processes and inspire to delight our business partners...