Regulatory Affairs Manager

Work Schedule

Other

Environmental Conditions

Office

Job Description

Thermo Fisher is looking for a highly skilled and experienced Regulatory Affairs professional to lead our Regulatory Affairs team based in Vilnius, Lithuania. This is an outstanding opportunity to play a pivotal role in an innovative, industry-leading company.

As a Regulatory Affairs Manager, your primary focus will be on guiding a team responsible for the planning, managing, and tracking of regulatory CMC submissions and regulatory documentation, including Drug Master Files for raw, ancillary, and starting materials used in the manufacturing of cell and gene therapies.

Responsibilities:

• Spearhead the organization of team activities related to the planning, managing, and tracking of regulatory CMC submissions and regulatory documentation, ensuring compliance with applicable laws and regulations;
• Collaborate with Regulatory Functional, Project and Business Leads to plan and prepare high-quality CMC submissions, ensuring timely and compliant submissions to global health authorities;
• Serve as the primary point of contact for project and/or submission teams with health authorities;
• Act as a liaison between Research scientists and key cross-functional partners, including Regulatory Affairs, Quality Control, Manufacturing Sciences, Product Management, and IP Legal;
• Coordinate responses to queries from regulatory agencies and mentor regulatory project leads on CMC documentation requirements;
• Handle multiple regulatory submission projects in eCTD format and the development and maintenance of submission content plans;
• Maintain technical expertise of regulatory requirements, CMC and ensure alignment with company processes and customer requirements.

Requirements:

• A B.Sc. degree in Biology, Chemistry, Bio-engineering, or a related science;
• Proven experience, at least 3-5 years, in Pharmaceutical, Biologics, In vitro diagnostics, or Medical Devices fields in Regulatory Affairs or Quality functions;
• Familiarity with CTD regulatory submission formats is a must.

Skills:

• Proven expertise in technical writing;
• Experienced in managing teams;
• Excellent communication and interpersonal skills;
• Strong project management, organizational, and time management skills;
• Familiarity with global Health Authority regulations/guidances e.g., FDA regulations, ICH and EMA guidelines/directives;
• Proficiency with computer programs/systems (MS office, etc.) and the ability to learn new systems quickly;
• Solid analytical and problem-solving skills with proven managerial competencies.

We offer:

• The innovative environment of the rapidly growing international company;
• High-performing, driven and supportive working culture and outstanding development possibilities to increase your potential;
• An exciting opportunity to be part of a dynamic global organization and work with experienced professionals;
• We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company pension, and a range of employee benefits;
• Monthly salary 3442 - 5167 Eur Gross.

Compensation and Benefits

The salary range estimated for this position based in Lithuania is €41 300,00–€62 000,00.