The newly created Regulatory Affairs and Quality Assurance Lead will be responsible for the implementation of the global regulatory strategy for products working in collaboration with senior regulators, project managers, regulatory scientists and country/regional regulatory affairs managers. This position offers the opportunity for a Quality Assurance professional with Regulatory Affairs experience to develop further a career in the regulation and compliance of development and marketed products.
The position requires demonstrated initiative in the compliance management of projects directly linked to the success of the business in the areas of product development, line expansion, growth, and sourcing, in all geographies and across all product lines. The successful candidate will report to the Senior Director of Regulatory Affairs and Quality Assurance and be a member of a highly interactive and supportive team.
- Develop and implement a global regulatory strategy for regulatory submissions and manufacturing changes, developing the path forward and meet submission deadlines ensuring timely approval of product authorization.
- Responsible for authoring regulatory submissions, compliance and Life Cycle Management (LCM) of IND, NDA, ANDA, DMF, MAA, Manufacturing/Wholesale License Applications, Annual Reports, Supplements/Variations and Annual Product Reviews.
- Provide QA expertise and guidance.
- Lead preparations for internal and third-party audits, preparing audit reports and responses to observations, providing recommended conclusions and actions with implementation.
- Facilitates audits with regulatory agencies.
- Maintain compliant systems and processes for global clinical and commercial products.
- Provide timely and effective evaluation and resolution of recommended changes/corrective/preventative actions.
- Responsible for providing Regulatory and Quality Assurance guidance and strategies for Change Control activities.
- Author, coordinate the Regulatory/QA review and approval of technical documents and reports, quality agreements, validation documentation, protocols and Master Batch Records.
- Maintain compliant and complete document management system.
Evaluate complaints and conduct investigations.
- Ensures project deadlines and performance standards are established and met.
Qualifications, Knowledge and Skills Desired:
- Scientific college degree (Bachelor of Science or equivalent degree)
Eight plus years of pharmaceutical experience in Regulatory Affairs and/or Quality Assurance
Minimum of 5 years in Quality Assurance with progressive responsibilities.
- Ability to think strategically across technical disciplines
- Experience handling regulatory inspections and preparation of regulatory submissions
- Willingness to travel
- Strong understanding of FDA and EU regulatory requirements for the pharmaceutical industry
- Working knowledge of the drug development and commercialization processes
- Experience with latest practices in risk assessment
- Ability and desire to work effectively in a multidisciplinary team environment
- Strong problem-solving ability
- Excellent written and oral communication skills
- Ability to manage multiple and varied tasks, prioritize workload with attention to detail with strong organizational skills
Cv to Gerry Kennedy at The RFT Group on firstname.lastname@example.org / 01 2302400 / www.rftgroup.ie