The Company – Syner-G Pharma Consulting, LLC:

· A young, dynamic, entrepreneurial, and growing regulatory and technical consulting firm providing specialized consulting and contracting services in the areas of Chemistry, Manufacturing and Controls (CMC) for biopharmaceutical companies (small molecule and biologic products)

· Adept in developing risk-based CMC strategies following cGMP for 21st Century initiatives and Quality by Design (QbD) principles

· Distinguish ourselves by our passion for creativity and innovation

· Offer flexible work environment that allows for on-site, off-site, and virtual-office scenarios

· Clients include national and multinational pharmaceutical companies

The Candidate:

Syner-G Pharma, CMC Consulting is seeking an exceptional science professional to join our Regulatory Affairs team. The candidate will be responsible for supporting our Biotechnology/Pharmaceutical clients throughout the regulatory filing process, including serving as the client lead as Manager of Regulatory Affairs. A successful candidate will have a proven track record of learning and applying scientific principles to solve CMC technical and project management challenges. Seeking a passion to help patients by enabling the expeditious development and approval of high-quality, life-saving medicines.

Required Activities/Experience:

· MS in Chemistry, Biology, Chemical Engineering, Pharmacy, Healthcare, Public Health, or a related field.

· 3-7 years’ experience in the Authoring and review of CMC sections for NDA, BLA, IND, and IMPD with a minimum of 1 year of experience with BLA/Large Molecule

· Creation and authoring of global and regional dossiers (IND, IMPD, and Canadian QOS).

· Coordinate timely & accurate assembly of responses to inquiries from the FDA on CMC content

· Strategize regulatory CMC pathway for new small & large molecules

· Assess and strategize post-approval changes and relevant submission

· Authoring CMC amendments, supplements, and annual reports

· Preparing briefing documents for the health authority meetings

· Regulatory agency meeting support including meeting preparation and briefing document creation.

· Review of analytical test methods, specifications, and stability protocol/report/data

· Support and prepare other CMC ad-hoc requests at the pre & post-approval stage of the product

· Coordinate timely & accurate assembly of responses to inquiries from the FDA on CMC content

· Sponsor consultancy regarding drug development including timeline management

Critical success factors:

· Ability to work with diverse stakeholders, both internally and at commercial contract manufacturers.

· Strong knowledge and demonstrated practice of cGMP.

· Detail-oriented with strong written and oral communication skills and proven history of working with others in a multidisciplinary team environment.

· Ability to troubleshoot problems, work within a team, and independently design, develop, and execute experiments.

· Ability to manage several projects simultaneously, creative in developing strategies for solving problems, and is driven by project requirements such as milestones and timelines.

Job Category: Chemistry Manufacturing and Controls Manager
Job Type: Full Time

Apply for this position

Allowed Type(s): .pdf, .doc, .docx