CMC Group Manager bei Gsk

Key Accountabilities/Responsibilities:

• Leads and mentors a group of regulatory professionals. Provides coaching, direction and oversight to CMC staff to ensure adequate capabilities to deliver business objectives, in close collaboration with local and global teams. Maintains a well-motivated, engaged and resilient team.
• Oversees and supports the development of successful regulatory strategies, preparation of regulatory submissions for new pipeline and currently marketed products to achieve desired business outcomes, including responses to Health Canada requests. Leads efforts to improve GSK submission approval times, achieve competitive labelling, resolve product-related issues, including associated risk communications, and ensure continued supply.
• Builds relationships and trust with a wide range of internal partners and external stakeholders to support the needs of the business, including overseeing and leading interactions with Health Canada for consultations and throughout the submission review process to ensure timely regulatory approval.
• As a member of the Canada Regulatory Affairs leadership team, contributes to the development and implementation of future-focused divisional strategic plans.
• Supports the development of staff and builds a talent pipeline.
• Manages project prioritization and resource allocation for CMC functions or projects within specialization area.
• Leads change and delivers results in the most effective way possible.
• Develops strategies to maximize and drive efficiencies in regulatory processes.
• Collaborates with global regulatory affairs to ensure alignment of regulatory strategy and to achieve business objectives.
• Ensures compliance with applicable Health Canada, industry & GSK codes and guidelines in alignment with business needs.
• Supports influencing and shaping Health Canada policies to create a supportive regulatory environment to achieve business objectives.

Qualifications Required:

• B.Sc. in life science or relevant scientific field (e.g. pharmacology, toxicology, chemistry)
• Extensive experience in Regulatory Affairs
• Excellent applied scientific knowledge & skills, with an ability to interpret, summarize and communicate scientific data in area(s) of accountability
• Must possess a sound understanding of the Canadian Food & Drug Regulations, relevant guidelines and policies, and the Health Canada organizational structure and processes for the review and approval of health product submissions
• Working knowledge of global regulatory agencies and their practices
• Must possess a thorough understanding of the drug development and commercialization process
• Highly innovative (strategic and functional), creative problem solver and decision maker, who can apply continuous improvement techniques to gain efficiencies in submission preparation and product approval process
• Strong ability to apply and leverage scientific knowledge for commercial value. Must
• work as a strategic partner with commercial and other cross-functional partners
• Strong business and financial acumen. Strong strategic thinking skills at the therapeutic level
• Demonstrated business planning ability
• Active owner and leader of change
• Strong coaching and leadership skills with well-developed interpersonal, team building and people management skills and experience. Demonstrated record in achieving results through others, building teamwork and developing the overall capability of a unit
• Excellent communication, influencing, negotiation and relationship management skills
• Ability to engage constructively with others and demonstrate a positive mindset. Willingness to welcome open discussions by inviting and encouraging diverse ideas, styles and perspectives
• Must act with integrity and demonstrate a strong and effective risk management perspective
• Strong commitment to quality mindset
• Proactive and seeks to constantly learn and develop, to ensure that skills meet changing business needs

Preferred Qualifications

• Graduate degree and/or Post-Graduate Certificate in Regulatory Affairs.

Why GSK?
Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. GSK is committed to accommodating persons with disabilities. If you need accommodation at any stage of the application process or want more information on our accommodation policies, please contact us at [email protected].  Please do not send resumes to this e-mail and instead apply through the online application process of this posting.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.