Director, CMC, FDA Experience

1 month ago

delhi, India Allucent Full time
Description
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 (e.g., 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 B.S., R.Ph., M.S., Ph.D., 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 global offices.
“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.”

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