Associate Director, Regulatory Affairs

4 weeks ago

hybridremote india myGwork Full time

This job is with Parexel, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Key Responsibilities

  • Clinical Trial Regulatory Submissions: Over 15 years of relevant experience in clinical trial regulatory submissions.
  • Regulatory Leadership: Experience in managing clinical trial studies, serving as Regulatory Lead for global trials, with exposure to the European market.
  • Database Expertise: Proficiency in handling the CTIS database and submitting EU CTR and CDSCO is desirable.
  • Project Profitability: Monitor the profitability of multiple projects/programs through active involvement with project leads in preparing project plans and managing project budgets.
  • Revenue Recognition: Proactively avoid and resolve issues with revenue recognition.
  • Team Collaboration: Work within a team environment or individually based on project needs.
  • Mentorship: Provide guidance to project team members and act as a mentor to staff.
  • Issue Resolution: Work within broad project guidelines and lead issue and conflict resolutions.
  • Workload Management: Prioritize own workload and the workload of the project team to achieve project scope and objectives.
  • Efficiency Improvement: Capitalize on opportunities to improve project efficiency, results, or team performance and proactively take action.
  • Performance Management: Actively manage performance, including typical HR activities for direct reports (e.g., performance management forms, salary actions, bonuses, scorecards).
  • Staff Support: Provide input on staff to appropriate PC Members and support direct reports with the management of their staff.
  • Guidance and Accountability: Provide applicable guidance and support to staff to succeed and achieve key metrics; hold staff accountable to key metrics.
  • Staff Development: Facilitate staff development plans and coordinate with Strategic Resourcing staffing to ensure staff is utilized completely and appropriately to increase their expertise.
  • Skill Expansion: Collaborate with strategic resourcing to provide staff with opportunities to expand skill sets.
  • Recognition and Reward: Reward staff appropriately as needed.
  • Leadership and Mentoring: Provide leadership, coaching, mentoring, feedback, and role modeling to managers and extended staff to ensure quality and accuracy of services as well as achievement of key metrics.
  • Vision and Values Communication: Communicate and champion organizational vision and values.
  • Effective Communication: Regularly communicate with staff to assure effective two-way information flow (e.g., business updates, staff interests, issues, and/or concerns).
  • Consulting Services: Provide a full range of technical and/or business consulting services mainly in areas where policy or precedent is clear.
  • Self-Development: Define self-development activities to keep current within the industry (e.g., maintain membership in a relevant industry and/or scientific/technical association).
  • Project Efficiency: Capitalize on opportunities to improve project efficiency, results, or team performance and proactively take action.
  • Information Leverage: Leverage information from previous projects or other client work to efficiently complete assigned project activities and facilitate business decisions.
  • Quality Work: Produce quality work that meets the expectations of the client. Review the work of colleagues for content and quality to ensure client and PC expectations are met.
  • Strategy Development: Assess project issues and develop strategies to meet productivity, quality, and project goals and objectives.
  • Performance Management: Actively manage performance, including typical HR activities for direct reports (e.g., performance management reviews, salary actions, bonuses, scorecards)

#LI-REMOTE

  • Regulatory Affairs Consultant

    4 weeks ago

    hybrid/remote, india myGwork Full time

    This job is with Parexel, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Regulatory Affairs expertise with medicinal products for changes with impact on Product Information - Safety /...

  • Regulatory Affairs Consultant

    4 weeks ago

    hybrid/remote, india myGwork Full time

    This job is with Parexel, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Regulatory Affairs expertise with medicinal products for changes with impact on Product Information - Safety /...

  • Director of Regulatory Affairs

    4 weeks ago

    india Vehere Full time

    Job Summary:The Director of Regulatory Affairs will lead the regulatory compliance strategy for Vehere, ensuring that all products, technologies, and services meet regulatory requirements across Indian markets. This role will involve managing regulatory submissions, advocating compliance standards, collaborating with cross-functional teams, and staying ahead...

  • Associate Director, Regulatory Affairs

    4 weeks ago

    hybrid/remote, india myGwork Full time

    This job is with Parexel, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Key ResponsibilitiesClinical Trial Regulatory Submissions: Over 15 years of relevant experience in clinical trial...

  • Regulatory Affairs Executive

    6 days ago

    Remote, 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 Associate

    3 weeks ago

    Remote, India Parexel Full time

    As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...

  • Regulatory Affairs Associate

    1 week ago

    Remote, India Parexel Full time

    As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...

  • Regulatory Affairs Director, APAC

    3 weeks ago

    India Solventum Full time

    Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear...

  • Regulatory Affairs Director, APAC

    3 weeks ago

    india Solventum Full time

    Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear...

  • Senior Regulatory Affairs Associate- Labeling

    4 weeks ago

    hybrid/remote, india myGwork Full time

    This job is with Parexel, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Job Description-Must have 4+ years of experience in drug development especially in labeling, product package...

  • Senior Regulatory Affairs Associate- Labeling

    4 weeks ago

    hybrid/remote, india myGwork Full time

    This job is with Parexel, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Job Description-Must have 4+ years of experience in drug development especially in labeling, product package...

  • Regulatory Affairs Officer 627

    3 weeks ago

    Remote, India ProductLife Group Full time

    Responsibilities In the context of a project for one of our top Pharma client, we’re looking for 2 talented Regulatory Affairs Officer to lead the following missions, and much more! Compile, or supervise the compilation of regulatory dossiers Provide on-going regulatory advice to project teams to ensure regulatory concerns are planned and accounted for...

  • Regulatory Affairs

    3 days ago

    India Sunrise Remedies Full time

    Sunrise Remedies Job Opening for Regulatory Affairs (RA). **Experience**: Minimum 2 Years **Industries**: Pharmaceutical Company **Education**: B.Sc. / M.Sc / B.Pharm / M.Pharm **Job Location**: Santej Ahmedabad. **Key Responsibilities**: - Regulatory Affairs Specialists assist in obtaining and maintaining government approval for drugs, medical devices,...

  • Director, Global Regulatory Affairs

    3 weeks ago

    India GlaxoSmithKline Pte Ltd Full time

    Job DescriptionSite Name: USA - Pennsylvania - Upper Providence, Durham Blackwell Street, Rockville Vaccines, Waltham Posted Date: Feb 4 2025 At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines...

  • Senior Regulatory Affairs Manager

    4 weeks ago

    Bengaluru, India Respironics Inc Full time

    Job Description Job Title Senior Regulatory Affairs Manager Job Description Job Description: In this role, you will lead a Regulatory Affairs Team for our Magnetic Resonance Imaging (MRI) Business Unit, Bangalore & Pune. You will also be accountable for developing and deploying innovative, compliant regulatory strategies to grow and sustain the MRI...

  • Regulatory Affairs Specialist CMC

    4 weeks ago

    india, india, in Adalvo Full time

    At Adalvo, we're not just a company - we're a team of passionate people driven by our mission to consistently deliver high-quality products and services to our partners. We are positive, we are fast, we are always on target, we are Adalvo! 🎯 🚀We are looking for an enthusiastic Regulatory Affairs Specialist, CMC to join our dynamic Regulatory Affairs...

  • Regulatory Affairs Specialist

    4 weeks ago

    india Tata Consultancy Services Full time

    TCS is hiring forRegulatory Affairs Role !!!Location:MumbaiExperience:5 to 8 yearsJob Description:1) Minimum 5 to 8 Years experience in Regulatory Affairs with minimum 2 Years direct exposure in Regulatory Publishing.2) Candidates should have hands-on experience in eCTD, CTD, ACTD, NeeS submission Experiences.3) Candidates must be exposed with IND, NDA, BLA,...

  • Regulatory Affairs Consultant

    2 weeks ago

    India Apsida Life Science Full time

    Apsida Life Science has partnered with a leading biotech company who are looking for a Regulatory Affairs ConsultantThe Regulatory Affairs Consultant is required to support CMC activities in drafting submission dossiers for new vaccines.Key Responsibilities:Prepare IND and IMPD DS & DP for Phase I/II/III studies, ensuring alignment with appropriate templates...

  • Senior Manager Regulatory Affairs

    4 weeks ago

    india Omnicals Pharma Limited Full time

    Company DescriptionOmnicals Pharma Pvt Ltd is a Mumbai-based company specializing in Global Pharma Business Development. We work with prestigious clients who are approved by regulatory bodies, with presence in more than 50 countries, we are expanding further and looking for extensive RA team to Hire.Role DescriptionThis is a full-time on-site role for a...

  • Medical Device Regulatory and Clinical Affairs

    1 week ago

    Remote, India Medidee Full time

    **Career opportunity** **Consultant - Medical Device Regulatory and Clinical Affairs** **Project Associate - Remote, India **compliance with international regulatory requirements. We serve clients with hands-on support for compliance with applicable regulatory requirements of our clients’ target markets. Our services cover all steps of Medical Device and...