Bayer Hiring Regulatory Affairs Manager

Bayer Foundations vision is to catalyze advances in Science and Social Innovation for a world with Health for all, Hunger for none. There is no meaningful progress without science and social innovation. Fundamental research and cutting-edge advances in science are the basis for progress. Social innovators bring concrete and long-lasting change to people and communities.

Post : Manager - Regulatory Affairs

Job Description
• Responsible and accountable for all Regulatory Affairs activities concerning Radiology drug products in India (IN), Nepal (NP) and Sri Lanka (LK). To provide effective functional leadership and governance into planning, development and execution of regulatory strategies within assigned scope.
• Prioritisation and alignment of regulatory work with business plans and strategies through cross-functional collaboration. Provide regulatory expert input to all stakeholders in development of business plans and strategies and on Issue Management.
• Scope of regulatory activities includes all maintenance and development product activities dealing with the relevant Health Authorities and government bodies in relation to Radiology contrast media marketing authorisation/permission/notification as appropriate based on assigned geography.
• The position will have to consider and balance the business objectives and priorities within assigned portfolio and geography, allocating resources accordingly.
• Works independently to ensure best regulatory planning and preparation for all new chemical entities, new indications and line extensions to be registered in the best possible timeframe and with the best possible label. Maintains full awareness of all regulatory activities for assigned geography and ensures project deadlines and performance standards for these projects are established and met.
• Ensure that the overall regulatory functions and products in scope remain compliant with all relevant regulatory, corporate and legal policies, procedure and practices throughout their product life cycle. Develop and implement standards to enable compliant practices and processes.

• To partner with relevant stakeholders within PH and Radiology as appropriate to assist in achieving optimal company outcomes, cross-functionally and not limited to IN/NP/LK only but also the AP region and global regulatory affairs.
• To support the APAC contrast media regulatory development and compliance activities to ensure appropriate global, regional and local collaboration and communication amongst commercial, product supply and regulatory.
• Position holder shall provide leadership to ensure all assigned goals are achieved in the most optimal and efficient manner with a solution oriented ‘can do’ approach.
• Ensure local maintenance of required licenses for proper functioning of the company e.g. GMP certificate, manufacturing license/s (if applicable), special functioning licences, and provision thereof on request.
• To ensure local regulatory practices and procedures reflect current best practice.
• applicable), special functioning licences, and provision thereof on request.
• To ensure local regulatory practices and procedures reflect current best practice.
• Work closely with regional and global regulatory affairs in setting and leading local regulatory strategic and operational matters of assigned portfolio to fulfil the local business strategies, in coordination with local functions.
• Ensures transparent, timely and efficient communication with business, supply chain and other local functions and global regulatory affairs, providing regulatory expertise to achieve common decisions. Effectively manages priorities within responsible portfolio.

Functional excellence responsibilities :
* Leading contribution to operational activities within the team to assure diligent and professional regulatory checks and timely delivery of documentation, compliance support to R&D and other stakeholders on development activities and issue management.
* Continuously identifies and implements efficiency, productivity goals for integrated RA organisation (resources, processes, systems).
* Works closely with regional and global regulatory to identify resource requirements within assigned geography and manages own resources to meet regulatory needs. Ensures early identification of conflicts between projects and ensures transparent and aligned prioritisation in consultation with global regulatory and Head of Commercial Radiology.
* Ensures preparation of the application files for products based in the documentation from RA regulatory partners in accordance with local regulation, is of acceptable standard and quality for the respective authorities.
* Where applicable, ensures the preparation of the application files for clinical trials, based on the documentation provided from RA regulatory partners, are in accordance with the local regulations and presents them to the respective authorities, where locally relevant.
* Work closely with Pharmacovigilance (PV) for PSUR and AE reporting as needed.
* Work closely with Quality to provide regulatory expert input to manage product complaints and recall process, including health authority interaction and communications. Provide necessary.
* functional input and documents to enable Quality to complete local compliance checks and develop local QSD process.
* Where applicable, support and oversee product registration and maintenance for export products, local and regional tenders.
* Ensure mandatory compendial/pharmacopeial compliance of input materials and finished products. Obtained revised product permission from State Drug Authorities in case of compendial/pharmacopeial amendments of finished product label claim
* Handling the test licence applications to the zonal offices for import of required materials for testing in India. Coordinate testing of drug formulations at central drug testing laboratory and other laboratories as relevant as part of the registration process as well as commercial consignments. Provide technical support for the analysis of imported products by Authorities or samples drawn by ADC customs.
* Works closely with distribution partners in NP and LK to ensure that regulatory objectives are met and to ensure supply and compliance are maintained for CME in those respective markets.

Candidate Profile
• Master’s degree in Life Sciences or equivalence scientific degree with minimum of 5-7 years pharmaceutical industry experience in regulatory affairs with at least 2 years of proven leadership/technical specialist role experience in health authority interactions and negotiations, in managing projects and resources and demonstrated track record of providing workable solutions to complex regulatory problems. Sound pharmaceutical product knowledge and hands-on experience across various types of applications, experience with contrast media an asset.
• The experience to act as an effective business partner to country commercial organisation. He/she will need to be a self-starter with excellent interpersonal and communication skills to facilitate the ability to negotiate and influence others, while dealing with issues which have considerable scientific and regulatory uncertainty.
• Analytical capability to evaluate complex/ambiguous situations and to proactively identify potential issues and future trends and to translate into business cases. Ability to come up with solutions to deal with heterogenous environment.
• Fluent in English and local language. Excellent communication skills to communicate effectively both orally and in writing, with proven persuasive, assertive and negotiating skills to represent the company at external meetings and report issues, strategies and activities to IN country management and regional management teams as well as RA global/regional management.
• Ability to focus on multiple issues at one time, ability to organize, prioritise and direct diverse activities in a changing environment often under time pressure.
• Excellent interpersonal skills to both independently and with local/global counterparts in line with our company LIFE values and to effectively support IN/NP/LK and APAC businesses and RA goals.

Location: India : Maharashtra : Thane
Division: Pharmaceuticals
Reference Code: 820385