Director, CMC, FDA Experience

2 weeks ago

india Allucent Full time

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Director, Chemistry Manufacturing and Controls (CMC) (Director, CMC) to join our A-team (hybrid*/remote). As a Director, CMC at Allucent, you are responsible for assisting clients with CMC and related pharmaceutical development activities of drug, biologic or medical device products. The Director, CMC leads and/or participates in Health Authority (HA) communications including correspondences with the FDA and EMA, and reviews, provides advice on, or authors CMC-related regulatory content for HA submissions, reports, protocols, and other scientific documents, including new drug market applications (, INDs, BLAs, NDAs, IMPDs).

In this role your key tasks will include:

Reviews and/or writes regulatory/scientific documents or sections thereof, with efficiency, accuracy, and independent thought Contributes significantly to strategic/CMC discussions and associated documents/reports regarding drug, biologic, or device development Guides the writing of regulatory/scientific documents written by other project team members Has advanced scientific knowledge of HA Regulatory Guidance and Regulations Interacts with various HAs, including leading HA meetings and participating as a subject matter expert; assists in preparation of meeting and briefing documents, and preparing responses to inquiries Contributes significantly to strategic/CMC discussions and associated documents/reports regarding drug, biologic, or device development issues with primary emphasis on scientific aspects Has advanced understanding of electronic common technical document (eCTD) format and requirements of regulatory submissions Prepares product development plans and/or strategies from early development through Phase 4 Provides strategic advice in evaluating impact and necessary filing requirements and strategies for drug product post-approval changes/variations May provide expertise in GMP and GLP audits, inspection readiness and remediation activities Participates in meetings with clients and leads discussions in scientific area(s) of expertise as subject matter expert

Requirements

To be successful, you will possess:

Requires a , , , , or equivalent degree, in a scientific area, and equivalent combination of relevant experience in drug, biologic, or device development. Scientific and regulatory knowledge of drug, biologic, or device development Critical thinking and analytical skills, as well as strong written and verbal communication skills in English Strong computer skills, including SharePoint, Word, Excel, and PowerPoint Quality focus Emotional intelligence and decision-making skills Innovative, creative, and practical thinking including problem-solving skills ≥ 6 years’ post-degree of directly relevant experience in drug, biologic, or device development desirable

Benefits

Benefits of working at Allucent include:

Comprehensive benefits package per location Competitive salaries per location Departmental Study/Training Budget for furthering professional development Flexible Working hours (within reason) Opportunity for remote/hybrid* working depending on location Leadership and mentoring opportunities Participation in our enriching Buddy Program as a new or existing employee Internal growth opportunities and career progression Financially rewarding internal employee referral program Access to online soft-skills and technical training via GoodHabitz and internal platforms Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees

Disclaimers:

*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our .

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”

#LI-AH1

  • Director, CMC, FDA Experience

    2 weeks ago

    India Allucent Full time

    DescriptionAt Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Director, Chemistry Manufacturing and Controls (CMC) (Director, CMC) to join our A-team (hybrid*/remote). As a...

  • Director, CMC, FDA Experience

    2 weeks ago

    india Allucent Full time

    DescriptionAt Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Director, Chemistry Manufacturing and Controls (CMC) (Director, CMC) to join our A-team (hybrid*/remote). As a...

  • Regulatory Affairs Specialist

    3 weeks ago

    India Apsida Life Science Full time

    Regulatory Affairs Specialist - CMC Variations/Submissions12 month contract - Immediate startOverview: Join our Regulatory Affairs team and contribute to the management of Chemistry, Manufacturing, and Controls (CMC) You’ll be pivotal in ensuring compliance and efficiency in our regulatory processes.Key Responsibilities:CMC Change Control Assessment:...

  • Regulatory Affairs Specialist

    3 weeks ago

    india Apsida Life Science Full time

    Regulatory Affairs Specialist - CMC Variations/Submissions 12 month contract - Immediate start Overview: Join our Regulatory Affairs team and contribute to the management of Chemistry, Manufacturing, and Controls (CMC) You’ll be pivotal in ensuring compliance and efficiency in our regulatory processes. Key Responsibilities: CMC Change Control...

  • Scientist - CMC (Analytical)

    1 week ago

    india Ferring Pharmaceuticals Full time

    Job Description: Role : Scientist  Reports to : Associate Director - CMC (Analytical) Location : Hyderabad, India Purpose of the Role : Work both as individual contributor and in collaboration with team to facilitate & drive timely achievement of CMC & R&D objectives, from CMC (Analytical) function. Qualification : Ph.D (preferred), M. Pharma/M.Sc in...

  • Assistant Scientist

    1 week ago

    india Ferring Pharmaceuticals Full time

    Job Description: Position : Assistant Scientist / Scientist - CMC (Formulation) Reporting to : Lead scientist/Associate Director -CMC Location : Hyderabad, India Education/Qualifications : M. Pharm/Ph.D from premier institute. Experience : At least 7-9 years of industrial research experience, in the field of formulation development for differentiated...

  • Assistant Scientist

    1 week ago

    india Ferring Pharmaceuticals Full time

    Job Description: Position: Assistant Scientist / Scientist - CMC (Formulation) - Injectables Reporting to: Lead scientist/Associate Director -CMC Location: Hyderabad, India Education/Qualifications: M. Pharm/Ph.D from premier institute. Experience: At least 7-9 years of industrial research experience, in the field of formulation development for...

  • Regulatory Affairs Specialist – CMC 215

    3 weeks ago

    india ProductLife Group Full time

    Specific activities and responsibilities: Review the drug product dossier section ( specifically 3.2.P.2 and 3.2.P.3 ) as per the EU regulatory requirement. Aware of regulatory requirements, and technical knowledge of various pharmaceutical dosage forms. Project coordination and management skills CMC regulatory requirements for other than...

  • Experience Design Director

    7 days ago

    india Shobiz Experiential Full time

    Job Summary Creative directors guide the direction of creative projects by developing a big-picture vision and brand guidelines. They oversee every stage of the creative process, approving artwork, strategy and other project elements. Key Responsibilities 1. Strategic Event Design: Develop a comprehensive event design strategy that aligns with client...

  • Deputy Director, Participant Learning Experiences

    1 week ago

    india TeachForAll Inc Full time

    Deputy Director, Participant Learning Experiences The Academy @ Teach For All’s Global Institute for Transforming Education Remote locations: Bangladesh, Côte D'Ivoire, Ghana, Hong Kong, India, Kenya, Malaysia, Mauritius, Malawi, Nigeria, Philippines, Rwanda, South Africa, Thailand, Tunisia, Uganda, UAE, Zambia, Zimbabwe, Qatar, Jordan  ...

  • Store Director

    1 day ago

    india Work Tonic Full time

    Our client, is a prestigious multi-designer boutique store for fashion enthusiasts seeking a curated collection of diverse designer labels, styles, and trends under one roof. Established in 2012 with a vision to make luxury accessible to the dear audience, our client has penetrated the wardrobes of fashionistas of Chennai. Based at an upscale locality of...

  • Art Director

    7 days ago

    india Adwants Full time

    Company Description : Adwants is an integrated agency offering brand, strategy and digital solutions. Serving clients across the globe from 3 offices, Chennai, Bengaluru and Dubai. Position Overview: As an Art Director, you will collaborate closely with the Content, Client Servicing and design teams to create engaging and on-brand visuals for various...

  • Executive Director

    2 days ago

    india PEMS Digital Technologies Pvt Ltd Full time

    Company Description PEMS Digital Technologies Pvt Ltd is a newly formed digital solution firm to optimize decision-making processes and ensure digital transformation. Our focus is on transformation construction sector through data-driven approaches. We believe in the power of united communities to drive positive change and are passionate about creating...

  • Regulatory Affairs Manager

    7 days ago

    india USV PRIVATE LIMITED Full time

    Organisation : USV, a top -15 pharmaceutical company in India, excels in the diabetes and cardio sectors. With a presence in over 65 countries, our dynamic team of over 7,000 spans generations. Our commitment to brand building is evident in our popular products like Glycomet GP, Ecosprin AV, Jalra, Tazloc, Glynase and more. Responsibilities: For the CMC RA...

  • Managing Director

    4 weeks ago

    india The Nature Conservancy Full time

    OFFICE LOCATION New Delhi, India WHO WE ARE ORGANIZATIONAL OVERVIEW: A PIONEER IN CONSERVATION LEADERSHIP This is an exciting time at The Nature Conservancy (TNC) as we are shifting our strategy for greater impact in the world, seeking to address some of the most complex challenges facing people and nature — issues such as...

  • Executive Assistant to Director

    7 days ago

    india Suncity Projects Pvt. Ltd. Full time

    Position Overview We are seeking a talented Executive Assistant to Director to join our team. The ideal candidate will be organized, detail-oriented, and capable of handling a wide range of administrative and executive support tasks. This role requires the ability to work independently with little or no supervision, as well as the capacity to manage...

  • Hospital Director

    16 hours ago

    india MindPlus Full time

    Company Description MindPlus is a leading mental health care provider located in Ludhiana. We specialize in the prevention, diagnosis, and treatment of mental health issues, disorders, and addictions for children and adults. Our holistic and collaborative approach to mental health care includes both inpatient and outpatient services, providing comfort and...

  • Assistant Director

    16 hours ago

    india Stealth Startup Full time

    We are seeking a dynamic and creative Assistant Director who is comfortable in front of the camera for our children-focused YouTube channel. This role requires a versatile professional to manage pre-production tasks, handle props, and occasionally step into acting roles, primarily portraying a nurturing figure in children’s educational and entertainment...

  • Associate Director Experience Design

    3 weeks ago

    india VML Full time

    DESCRIPTION At VML, we create connected brands. We resist the usual ways of seeing, doing, and thinking — harnessing creativity, technology and culture — to reimagine the entire connected consumer experience. Our goal? To create work that becomes part of people’s lives, to drive value for our clients and, in the best of cases, to impact the world. Our...

  • Assistant Director

    2 days ago

    india CHITRALEKHA STUDIOS Full time

    *This is an ad agency, we make only corporate films and ad films* *Apply only if you are interested in the advertising industry* Experience: 0-1 year or max 2 years Company Description We are a video production house based in Hyderabad. *Apply only if you are interested in ad film making* Role Description Chitralekha Studios is seeking a full-time...