Manager Regulatory Affairs - Head of Product Stewardship

ALTANA Wesel, Germany

Responsibilities

Exciting opportunities await you – as Regulatory Affairs Manager and Head of our Product Stewardship team, your task will be the management of regulatory requirements for our products: from ensuring the compliance of new raw material sources and qualities for our products with existing, changing and upcoming regulations to coordinating the evaluation and clearance of new raw materials and suppliers to leading our Product Stewardship team and reporting to the Global Head of Regulatory Affairs to acting as contact person for national and international authorities and institutes to engaging in important industry associations and industry consortia. Further duties include:

• Taking care of special regulations in application-related fields, e.g. food contact or cosmetics;
• Monitoring global regulatory customer requests;
• Implementing standardized and consistent responses to customer inquiries as well as customer and industry portals;
• Creating regulatory BYK documents;
• Handling disclosures of confidential information;
• Advising on BYK's marketing strategy with regard to the publication of regulatory product information;
• Providing regulatory information for business line and end use managers;
• Supplying stakeholders with regulatory information on ensuring BYK product compliance;
• Participating in the staging of training courses and seminars.

Requirements

With this profile, you convince us – if you are versed in the EU legal framework and specific regulations, e.g. concerning the EU Ecolabel or conflict minerals, and bring ready business acumen, analysis, planning and prioritization proficiency as well as a track record in product communications resp. stewardship, we warmly invite you to apply. Your other skills and competencies include:

• University postgraduate degree, preferably a PhD, ideally in chemistry or business chemistry;
• Positive attitude, strategic thinking and dexterous communication;
• Leadership as well as team player qualities.

Senior Principal Consultant, Regulatory Affairs

Cytel

Stockholm or Uppsala, Sweden

Experience/qualifications

• Advanced degree in life sciences or related field (PhD, PharmD or MSc or equivalent);
• Minimum of 10 years of experience in regulatory affairs within the pharmaceutical and/or biotech industry;
• Solid experience of strategic regulatory affairs in drug development phase (Phase I-III);
• Advanced understanding of regulatory requirements (EMA and FDA);
• Experience of regulatory authority interactions (EMA and FDA);
• Experience of regulatory submissions; authoring and compilation of e.g. briefing documents, IND, IMPD, IB, ODD, PIP, PSP, MAA/NDA, and related regulatory documentation;
• Solid understanding and experience of building regulatory strategies; regulatory roadmaps/TPP/TPC/CDS;
• Experience with compilation of label/USPI is meriting;
• Excellent communication and project management skills, with the ability to interact effectively with cross-functional project teams, clients and regulatory authorities;
• Fluency in English, both written and verbal.

Job description

• Lead and execute regulatory strategies and submissions to support clients according to their product development programs;
• Develop strategic documentation such as regulatory road maps, regulatory gap analyses, feasibility assessments, regulatory due diligence, and Target Product Profile (TPP)’s/TPCs/CDSs for clients;
• Support, manage and lead scientific advice meetings and communication with regulatory authorities;
• Coordinate and compile regulatory submissions, which entail leading cross-functional teams including clinical, nonclinical and CMC to ensure alignment with regulatory strategies;
• Author and review regulatory documentation, e.g. briefing documents, IND, IMPD, IB, ODD, PIP, PSP, and MAA/NDA;
• Act as primary contact towards the clients and as project manager for the assignment, working closely with the client/Cytel Sweden project team members as well as other external cross-functional team members within the projects;
• Monitor regulatory intelligence and provide clients with insights into current standards, guideline updates and authority expectations;
• Educate others within Regulatory Affairs – externally and internally;
• Continuously and proactively improve internal processes and ways of working;
• Support sales activities such as client meetings and events as subject matter expert.