JOB DESCRIPTION. DATE: August 2017 Senior Regulatory Affairs Scientist. Regulatory Affairs Assistant Manager RESPONSIBLE FOR (PEOPLE): N/A

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1 JOB DESCRIPTION DATE: August 2017 POSITION: Senior Regulatory Affairs Scientist BUSINESS UNIT: Central Services LOCATION: Craigavon REPORTING TO: Regulatory Affairs Assistant Manager RESPONSIBLE FOR (PEOPLE): N/A OVERALL ROLE OBJECTIVE: The post holder will provide support in the development of new medicinal products and maintenance of approved products. They will co-ordinate the compilation and submission of regulatory documentation and required follow-up. JOB SPECIFIC RESPONSIBILITIES: The post holder will: Regulatory Submissions 1. Compile and submit applications for global Marketing Authorisation (MA) applications for new medicinal products, including obtaining and evaluating chemical, pharmaceutical, pharmacological, toxicological and clinical data required in these MA applications 2. Draft/co-ordinate the drafting of pharmaceutical, clinical and pharmacological/toxicological sections of MA applications and give advice as to format and content 3. Co-ordinate the submission of new MA applications through global regulatory procedures, for example national, pan-european and/or United States submission and assessment processes 4. Co-ordinate post-approval and lifecycle maintenance activities for approved MAs through global regulatory procedures, for example national, pan-european and/or United States submission and assessment processes 5. Maintain effective contact between the companies and Regulatory Authorities during assessment of applications and co-ordinate and/or draft the responses to comments from Regulatory Authorities 6. Co-ordinate and/or draft global applications relating to other regulated activities, for example clinical trial applications, manufacturing authorisations, orphan drug submissions Page 1 of 5

2 Product Development and Support Activities 7. Provide regulatory support for the development of new products and changes required to approved products, including the provision of advice on pharmaceutics issues and also the planning of clinical and pharmacological/toxicological strategies 8. Advise other departments and business partners on optimum regulatory application/submission strategies and assist in planning of projects 9. Advise other departments and business partners on information required by Regulatory Authorities to support MA applications or post-approval changes 10. Assist in the performance of due diligence activities in relation to the acquisition and divestment of medicinal products 11. Liaise with global business partners in support of approved medicinal products and in licensing of products in new territories 12. Support activities to ensure the ongoing compliance of products with their respective MAs 13. Respond to medical and technical enquiries as appropriate, including assistance with the provision of a medical information service Documentation 14. Review and assist with the drafting of specifications, protocols, reports and manufacturing and analytical documentation 15. Compile and maintain Standard Operating Procedures and work in compliance with those procedures as required 16. Keep up-to-date with and ensure compliance with all relevant regulatory guidelines General 17. Provide a professional, responsive and co-operative service at all times 18. Undertake other duties as assigned by Departmental Management Page 2 of 5

3 GENERAL ROLE RESPONSIBILITIES: Quality Health & Safety Training and Development Human Resource Management Communication Equal Opportunities Core Competency Framework Ensure GMP is adhered to in all areas of work. Understand Company s Health & Safety Policy and follow all company HSE procedures. Report all accidents or any unsafe conditions in the work place. Ensure training has been received before undertaking specific duties and that all training is recorded in training records. Adhere to all HR policies and procedures, to include all absence policies and procedures. Communicate within your own department to ensure that all relevant information is forwarded to the appropriate personnel on a regular and timely basis. Provide regular updates to your line manager regarding progress on required duties and the status of any projects. Observe and adhere to the company's Equal Opportunities and Dignity at Work policies ensuring that a neutral and harmonious work environment is maintained in which bullying and/or harassment does not occur. Ensure that all job specific responsibilities relating to the overall role objective are carried out in accordance with the requirements outlined within the Almac core competency framework. By signing this Job Description I accept that I have received and read the Job Description and have accepted the responsibilities identified therein. EMPLOYEE S SIGNATURE: PRINT NAME: DATE: This job description should not be regarded as conclusive or definitive. It is a guideline within which the individual jobholder works. It is not intended to be rigid or inflexible and may alter as the Company s strategic direction changes. Page 3 of 5

4 PERSON SPECIFICATION DATE: August 2017 POSITION: Senior Regulatory Affairs Scientist BUSINESS UNIT: Central Services LOCATION: Craigavon REPORTING TO: Regulatory Affairs Assistant Manager RESPONSIBLE FOR (PEOPLE): N/A ESSENTIAL REQUIREMENT DESIRABLE REQUIREMENT ASSESSMENT METHOD QUALIFICATIONS BSc (or equivalent) in Pharmacy or Life Science related discipline, e.g. Biochemical/Biomedical Sciences, Biology, Physiology, Pharmacology, Chemistry, Microbiology N/A Application Form and Documentary Evidence EXPERIENCE Experience of the compilation and submission of new MA applications through pan- European regulatory licensing procedures, principally the Decentralised and Mutual Recognition Procedures, and/or the maintenance of pan- European MAs Experience of the compilation and submission of new MA applications through US regulatory licensing procedures, and/or the maintenance of US drug approvals Experience of electronic regulatory submission processes Application Form and KEY SKILLS Excellent communication skills (both written and oral) Proficiency in the use of Microsoft Office packages to include Word, Excel and PowerPoint Ability to prepare and deliver formal presentations and briefings Experience in the use of Adobe Professional or similar software Psychometric Testing and/or Proven ability to organise, plan and prioritise tasks within a high volume, varied workload Proven ability to work effectively on own initiative and effectively contribute within a team environment Proven ability to maintain a high level of accuracy and confidentiality in all work undertaken Ability to appropriate and disseminate information Ability to appraise data critically. Page 4 of 5

5 ALMAC CORE COMPETENCIES COMPETENCY BEHAVIOUR ASSESSMENT METHOD RESULTS DELIVERY Delivers results on time, within constraints and in line with company policy and procedure and organisational strategy. Demonstrates a continuous drive for quality and a commitment to excellence. PROACTIVE SOLUTIONS Analyses and uses experience and logical methods to make sound decisions which solve difficult problems. Seeks practical/workable and innovative methods to deliver solutions. LEADS BY EXAMPLE Promotes a clear vision and mission. Acts as a positive role model for the organisation, fostering a climate of teamwork and development. COMMUNICATION Communicates clearly and effectively. Promotes the exchange of ideas and information across the organisation. Fosters dialogue to ensure everyone understands what is going on. CUSTOMER FOCUS Strives to exceed the expectations and requirements of internal and external customer; acts with customers in mind and values the importance of providing high-quality customer service. JOB SPECIFIC KNOWLEDGE Demonstrates required job knowledge and understanding to successfully and competently fulfill or exceed the requirements of their post. Follows correct procedures and guidelines (SOPs). Proactively demonstrates a desire to enhance and develop their job knowledge. Page 5 of 5