Manager Medical & Regulatory Affairs

Responsible for the management of the local portfolio including new and existing marketing authorizations in Pakistan & Afghanistan including products in other categories (cosmetics, medical devices and food supplement), providing guidance and advice to local business and regional/global functions on the regulatory& medical strategy development and processes as well as issues and risks. Represents BCH as a competent and reliable partner to the relevant competent authorities and stakeholders on all regulatory, medical and scientific matters.

YOUR TASKS & RESPONSIBILITIES:

• Supports the business growth and sustainability by managing regulatory activities and processes in line with the overall cluster and regional strategy.
• Supports the implementation of regulatory strategy, tailored to the special needs in Pakistan/Afghanistan.
• Supports the organization with product-related issue and risk management activities by providing regulatory and medical advice to internal partners including, Marketing, Quality, Business Development, regional and global RMSQC function in order to contribute to development and marketing processes, incl. licensing-in activities.
• Review the external regulatory environment and share intelligence with relevant internal parties, understanding and communicating the impact of the information in relation to the CH business.
• Represents Bayer as a competent reliable partner to the local Health Authorities & local trade association regulatory committees in all regulatory matters. Builds regulatory networking with national regulators, local industry organizations and key opinion leaders.
• To contribute to the development of medical strategy and to provide Medical input into brand strategies.
• Develops & maintains relationships with Thought leaders.
• Responsible for leading Medical activities in the assigned scope of countries (e.g. advisory boards).
• Contributes to the content of promotional materials and claims substantiation to support Bayer CH brands.
• Provides Medical guidance and governance for different therapeutic areas keeping up to date with Local and Global codes, regulations and laws.
• Reviews and approves external communication materials according to applicable local and international guidelines.
• Handling Medical inquiries concerning CH products either internally or externally per applicable Standard Operating Procedures (SOPs).
• Ensures team members are properly trained and ensures medical efforts are properly documented.
• To act as the company contact person and representative regarding the medical/scientific aspects of the drug for the scientific community.

WHO YOU ARE:

• Education: University degree or equivalent in pharmacy, pharmacology, chemistry or the biological sciences, preferably Ph.D., M.D., Pharm.D. orequivalent.
• At least 3 years’ experience in Drug Regulatory Affairs.
• Proven track record in consumer health Regulatory Affairs or related positions
• Demonstrated ability to work in a regulatory capacity supporting business objectives while ensuring appropriate governance.
• In-depth understanding of national regulatory requirements and experience in managing national registration procedures
• Customer focus & commercial awareness. Team spirit and people management skills.
• Ability to communicate effectively and assertively with sound negotiation skills. Ability to communicate complex information to all levels.
• Fluent in English

YOUR APPLICATION:

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.

To all recruitment agencies: Bayer does not accept unsolicited third-party resumes.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

Location: Karachi, Sindh, Pakistan

Division: Consumer Health

Steps to Apply:

Step 1:

Fill out the Form: Please complete the application form by providing all the required information and details accurately.

Step 2:

Share Your CV: Send your updated CV to [email protected] with the subject line: "Manager Medical & Regulatory Affairs".

Deadline: October 20, 2024