Description:
Job Title: Regulatory Manager CMC

Location: Belgium - Brussels area

Schedule: Permanent - Full Time - Office based

TalentSource is currently looking for a Regulatory Manager CMC to strengthen the team of one of our TOP Pharmaceutical client Companies. An operational role where you will be responsible to coordinate all steps of the registration process on an international level (except for EU, US and Japan). One of the main responsibilities will be to ensure the compilation of the files following local regulations and to ensure the follow-up and maintenance for the vaccines. In this role you will work independently and have some contacts with the affiliates.

For our client-facing positions, you must be confident and be able to drive the role and yourself and to work autonomously. You will have a close relationship with our Line Managers, who will provide you with mentoring and guidance. Most of our roles are permanent positions with CROMSOURCE and you will be working on studies for just one client. We are open, friendly and approachable and aim to support you through the recruitment process every step of the way.

Responsibilities:

• Regulatory Manager is responsible for the development and execution of Regulatory CMC strategies, submissions and compliance activities for biopharmaceutical projects/products from development to market and post-marketing, including the preparation and submission of correspondence and applications (IMPD's, MAA's,…) to regulatory agencies. Potential project responsibilities may include monoclonal antibodies, other recombinant proteins, vaccines, peptides and nucleotides. Depending on experience, may act as CMC liaison with regulatory authorities to discuss and define submission contents and strategies.
• Leads the preparation of CMC information for submission to regulatory agencies, generates CMC strategies, assesses risks and develops contingency plans. Ensures that CMC regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirements. Support preparation of interfaces with Boards of Health, including scientific reviewers, administrative staff, in order to discuss and define regulatory applications (Quality Module, Responses and Commitments. Depending on experience, may act as CMC representative in formal meetings and teleconferences with regulatory authorities.
• Act as the CMC representative and contributes support to the Global CMC representative within cross-functional project teams, involving the interpretation of regulations and guidelines and the assessment of global implications for strategic CMC decisions.
• Accountable for assigned CMC programs, managing day-to-day delivery of plans and strategic activities for specific projects, including Life Cycle Teams and compliance of commercial products.
• May operate independently to resolve complex issues and manage regulatory risks and ambiguous situations within project teams.
• Creates / contributes to the development of internal policies, processes and procedures supporting the progression and maintenance of the biopharmaceutical portfolio at large. Leads document management and information management teams, within Global CMC / groups outside Global CMC.
• Serves as a GCMC strategist for projects within product portfolios, providing regulatory assessments and developing regulatory strategies.
• Acts as the CMC representative and contributes support to the Global CMC representative, within cross-functional project teams.
• Interprets CMC regulatory requirements, develop strategies (including novel approaches), assess risks and develops contingencies. Uses technical and scientific knowledge to conduct the appropriate analysis of CMC submission documentation.
• Responsible for the development of CMC documentation, coordination and management of global submissions, including the assessment and management of commercial license status, maintenance of product compliance and management of change control.
• Ability to collaborate effectively across a network of other stakeholders, partners and customers, to deliver high quality CMC submissions and ensuring the compliance of the biopharmaceutical portfolio. Manages the resolution of regulatory CMC/information management issues with project/program stakeholders.
• Able to develop and/or lead projects or team initiatives to support short-term operational goals and contribute to the development of global regulatory initiatives.
• Collaborates across Global CMC and functional activities in a matrix environment, with globally located cross-functional project teams including representatives from World Wide Pharmaceutical Sciences / Worldwide R&D / Global Supply/Worldwide Regulatory Affairs.
• Interactions with regulatory agencies and/or external partners as required (either directly or in conjunction with Regulatory Affairs Department). May participate in pharmaceutical industry initiatives and support the development of the company positions to external regulatory policies.

Education and experience:

• University degree, Scientific (chemical, biochemical)
• Min. 2 years of relevant Experience in Biotechnical - Vaccines
• International Regulatory experience for full registration Vaccines dossiers (not local experience).

Skills:

• Leadership skills, influencing and persuading skills
• Excellent cross-cultural awareness and understanding
• Fluency in the English Language is essential
• Excellent communication, interpersonal and relationship building skills
• Collaborative team player
• Excellent planning, organizational and project management skills
• Proactive and flexible
• Technical and scientific understanding of biopharmaceutical drug development with technical writing skills. May serve as Subject Matter Expert in specific relevant disciplines or recognized as a regulatory CMC resource for specific pharmaceutical science projects and/or specialized expert in specific regulatory domains.
• Competent working knowledge of computer based systems such as Microsoft Office, controlled documentation systems (e.g. Documentum). Ability to learn and navigate tracking/change control systems, compliant and consistent use of systems (including GMP validated systems) and willingness to train and support others in system use.

Our benefits when working in Belgium:

• Competitive Salary
• Group and hospitalisation insurance
• Electronic meal vouchers
• Internet reimbursement
• Company Car with fuel card depending on the function
• Dedicated Line Manager
• Regular face-to-face or phone meetings with line manager
• Full annual performance review process
• Ad-hoc team events and end of year party
• Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
• Employee satisfaction survey - your feedback is important for continuous improvement

If you have the experience needed for this position, please apply directly to https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00001891

If you would like to discuss the role before applying through the website, please contact julie.casteleijn@cromsource.com for more information.

Why TalentSource Life Sciences/CROMSOURCE:

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously.

CROMSOURCE is an independent, international Contract Research Organisation (CRO) operating in over 40 Countries and 16 offices with approximately 500 professional team members, making it one of the largest independent CROs in Europe. Our international headquarters located in Verona, Italy and Waltham, USA and with local offices in Belgium, The Netherlands, Germany, Poland, Russia, Spain, Switzerland and the United Kingdom.

Our key approach is to equally value our clients and our own people. Our employees are the most valuable company asset and because we want to retain our staff, we ensure they work in a friendly environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel through our dedicated training team, focused on employee development. We also understand the importance of a good work-life balance and we offer flexible solutions for a high number of positions.

The success of these core values are evidenced by our below industry average turnover rates.

By joining our teams, you can be part of making a difference in the lives of people and experience a fulfilling and rewarding career. Together, we help our clients succeed in their work developing medicines and medical devices for patients around the world.

CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

How can we help you on your next career move? Learn more on LinkedIn, Pharmiweb, Facebook, Twitter, and Glassdoor.

Keywords: Regulatory Affairs, Regulatory, Quality Assurance

Skills: Quality Assurance, Regulatory Location: Belgium