Manager–Drug RA- EM_

6 days ago

Gurgaon, Haryana, India DDReg Pharma Pvt. Ltd. Full time

Job Descriptions

  • CMC review of technical documentation for regulatory filings to various markets – market: US- Gap Analysis and Remediation for module 3 -CMC
  • Development and implementation of regulatory strategies, processes and timelines for grant of MA- Africas, GCC, LATAM, ASEAN.
  • Review of CTD dossiers , variations, change controls, renewals and ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
  • Critically reviews documentation intended for submission to the respective agencies for internal consistency, for consistency to relevant guidelines and to promote regulatory excellence.
  • Demonstrate subject matter and area expertise.
  • Collaborate with internal and external clients,
  • Supporting and enabling effective and efficient communication that results in operational excellence.
  • Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on various agencies' website.

Education & Experience

  • Master's degree in Pharma
  • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 7 to 10 years') or equivalent combination of education, training, & experience.

Knowledge, Skills And Abilities

  • Excellent technical data interpretation skills
  • Excellent interpersonal skills including problem solving
  • Excellent oral and written communication skills with strong presentation skills
  • Significant knowledge of US Regulations
  • Excellent computer skills; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
  • Ability and desire to work in a team-oriented environment.
  • Excellent written and verbal communication skills
  • Highly proficient with Microsoft Word, PowerPoint and Excel.
  • Possesses a collaborative, results-driven style.
  • Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines

Other Requirements
As may be required from time to time – the incumbent may be required to working slots catering to different time zones

Location
Gurgaon, Haryana (INDIA)

Related Blog Post
Senior Manager-Regulatory Affairs-EU/US

Sr. Manager-Regulatory Affairs- US/EU Experience: -15+ YearsLocation: Gurgaon We are looking for an experienced and accomplished Senior Manager – Regulatory Affairs (CMC) with deep expertise in US and EU regulatory frameworks. The role will drive regulatory strategy, dossier submissions, and lifecycle management activities across these key markets, ensuring compliance and regulatory…

September 29, 2025

Asst-Manager RA_ ASEAN_(Onsite)_ (5+yrs Exp)

Job Purpose: The Asst. Manager – Regulatory Affairs (ASEAN) will lead regulatory strategy, submissions, and compliance for pharmaceutical products intended for the ROW markets. This is an onsite role based in Gurgaon. The individual will serve as a key regulatory liaison, ensuring products meet all regulatory requirements, supporting lifecycle management,…

December 8, 2025

Asst-Manager_ RA_ GHC/KSA_ (Onsite)_ (5+yrs Exp)

Job Purpose: The Asst. Manager – Regulatory Affairs (GHC/KSA) will lead regulatory strategy, submissions, and compliance for pharmaceutical products intended for the ROW markets. This is an onsite role based in Gurgaon. The individual will serve as a key regulatory liaison, ensuring products meet all regulatory requirements, supporting lifecycle management,…

November 24, 2025

  • Senior Associate– API_RA

    4 days ago

    Gurgaon, Haryana, India DDReg Pharma Pvt. Ltd. Full time

    Job DescriptionsCMC review of technical documentation for regulatory filings to various markets – market: EU & UK, US- Gap Analysis and Remediation for module 3 -APIPrepare and compile Section 322, QOS & QbR ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.Critically reviews...

  • RA/QA Manager

    2 weeks ago

    Gurgaon, Haryana, India Convatec Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    About ConvatecPioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide our...

  • Specialist, Regulatory Affairs FDF

    11 hours ago

    Gurgaon, Haryana, India Centrient Pharmaceuticals Netherlands Full time

    Supporting the RA-FDF Team and contributing in the regulatory activities in order to achieve the objectives of the department which are:  obtaining global approval for CENTRIENT products, including the lifecycle management of the registration dossiers according to business planning.Key Individual AccountabilitiesCollection of information and preparation of...

  • Senior - RA - Management

    2 weeks ago

    Gurgaon, Haryana, India KPMG Full time ₹ 12,00,000 - ₹ 24,00,000 per year

    **JOB DESCRIPTION About KPMG in India**KPMG entities in India are professional services firm(s). These Indian member firms are affiliated with KPMG International Limited. KPMG was established in India in August 1993. Our professionals leverage the global network of firms, and are conversant with local laws, regulations, markets and competition. KPMG has...

  • Senior - RA - Management

    2 weeks ago

    Gurgaon, Haryana, India BSR & Co Full time ₹ 5,00,000 - ₹ 15,00,000 per year

    DescriptionAbout KPMG in IndiaKPMG entities in India are professional services firm(s). These Indian member firms are affiliated with KPMG International Limited. KPMG was established in India in August 1993. Our professionals leverage the global network of firms, and are conversant with local laws, regulations, markets and competition. KPMG has offices...

  • Material Management

    1 week ago

    Gurgaon, Haryana, India Sunbrilo Technology Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    We are hiring for-Role: Material Management & Quality Management Business AnalystExperience:7+ YearsJob Description• Review and validate design documents, business process flows, functional specifications, user manuals, test scripts shared by implementation partner • Execute transaction testing for MM & QM processes - purchase requisition, ordering,...

  • Finance & Controlling Business Analyst

    2 weeks ago

    Gurgaon, Haryana, India Sunbrilo Technology Full time ₹ 6,00,000 - ₹ 18,00,000 per year

    Experience7-8 years of hands-on SAP FICO consulting and implementation experience in the construction section and less on leasingExperience in driving closure of Fit- Gap workshops with business counter parts and put objective lense on SI steering across stages - build, testing, deployment, and support.Should able to successfully drive closure on test...

  • Account Manager

    1 week ago

    Gurgaon, Haryana, India Officebanao Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    The ideal candidate will be responsible for working with senior management to develop financial strategies for the organization. You are comfortable handling large amounts of data, acting as a business partner, decision maker, and providing regular financial reporting.Experience required- 8-14 YrsBudget- 13 LPALocation- GurgaonResponsibilitiesProject Cost...

  • HR Manager

    3 days ago

    Gurgaon, Haryana, India DCM Shriram Full time

    The position is for Dr. Bansi Dhar Institute, Gurugram (please visit us at )HR & Administration Manager Research Institute (JD)ResponsibilitiesDevelop and implement HR policies suited to a research/academic setupHandle recruitment & hiring for faculty, researchers, technical staff, and admin staffManage onboarding, joining formalities, and HR...

  • Senior Quantity Surveyor

    21 hours ago

    Gurgaon, Haryana, India Voyants Solutions Full time

    QualificationB.E (Civil)/ Masters in QS (preferably)Job Description10 to 15 years of experience as a Quantity Surveyor(Exclusively of building projects)Experience in Estimating, Tendering, Reconciliation, Material, Cost Control, preparation of BOQs and Budgeting Management of Building projects.Good knowledge of 3Ds-Max, Auto Cad, REVIT, STAD Pro, MS Project,...