Regulatory Affairs Specialist III
- Contribute to authoring, review and provide comments for Chemistry Manufacturing and Control (CMC) CTD documents, including Investigational Applications (IND, CTX), Marketing Applications (NDA, NDS, MAA, BLA), and post-approval lifecycle dossiers, per the North American Regulatory Affairs Services Menu
- Collaborate and coordinate with SMEs to support the authoring and review activities of CMC CTD documents
- Prepare company regulatory submissions (e.g. site master files, drug master files)
- Support key company projects in the North America region such as new facilities, new strategic customers
- Contribute to moderately complex regulatory strategic advice for internal customers and clients
- Contribute to the maintenance of centralized records for compliance status of North American manufacturing sites
- Participate in regulatory impact evaluation of change controls
- Track NA Regulatory Services metrics for self-assist with collation and reporting out for North American network
- Contribute to regulatory intelligence surveillance and communication to the network
- Bachelor's degree in a scientific or related field is required. Advanced Degree preferred. Preferred Fields of Study: Engineering, Life Sciences, Chemistry or related technical field
- 3-4 years of regulatory experience in the pharmaceutical industry strongly preferred
- ASQ certifications (CQE, CQA) desired
- Strong knowledge of cGMP, ISO 13485/9001, and applicable regulatory requirements (FDA, EMA, etc.)
- Expertise in quality systems including: CAPA and deviation management, change control, risk management and FMEA, document control, and internal/external auditing
- Mature, results-oriented self-starter who can execute roles and responsibilities with minimal supervision.
- Ability to motivate and influence without line-management authority.
- Working knowledge of regional regulatory requirements and the global regulatory environment.
- Demonstrated ability to evaluate and resolve moderately complex regulatory and technical issues due to broad based knowledge of pharmaceutical manufacturing and related regulatory requirements.
- Strong organizational skills, with ability to multi-task in a fast-paced environment.
- Strong attention to technical detail.
- Highly effective verbal and written communication skills.
- Sound skills in typical office electronic platforms.
- Good negotiation and influencing skills with internal stakeholders, clients and regulatory bodies.
- Collaborative team player with strong interpersonal skills who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders, internal and external.
- Ability to demonstrate discretion, confidentiality and independent judgement.
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